Skip to content
Triangle logo TriangleGet started
← Thyroid Cancer

NCT04000880 · STUDY IN CONTEXT

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Participants completed two dietary recalls (one weekday and one weekend day) via telephone using a multipass method and the Nutrition Data Systems for Research (NDSR) software. The software averages the 2-day resulting data and calculates the Healthy Eating Index (HEI)-2015. The HEI indicates how closely someone's diet follows the Dietary Guidelines for Americans. The index range is 0 to 100 with an index closer to 100 indicating a healthier, well-balanced diet.

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

primary · POSTED

Participant body weight will be measured during an in-person or remote (Zoom) visit

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

primary · POSTED

Physical activity will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

secondary · POSTED

Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

secondary · POSTED

Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

secondary · POSTED

Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates percentage of body weight that is muscle mass.

The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Patient-reported symptom or function measure · Physical Activity - Godin (Patient Reported Outcome)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0011
source section id
NCT04000880-om-0011
source outcome index
11
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient reported' in the study's own wording
scale title
Physical Activity - Godin (Patient Reported Outcome)
measure definition
This physical activity outcome is measured using the Godin Leisure Time Physical Activity Questionnaire which asks frequency and duration of various levels of physical activity in a week period. The resulting outcome measure (minutes per week) is the Adjusted Godin Moderate-to-Vigorous Physical Activity (MVPA) score, calculated based on reported frequency and duration of moderate and strenuous (vigorous) leisure-time activities as follows: Adjusted Godin MVPA= (frequency \* duration of moderate activity) + 2 (frequency \* duration of vigorous activity)
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Quality of Life - Physical

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0012
source section id
NCT04000880-om-0012
source outcome index
12
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Quality of Life - Physical
measure definition
Quality of life - physical is assessed using the PROMIS global health subscales measuring self-reported overall physical health, including physical functioning, fatigue, pain, and general health perceptions. The outcome measure is the resulting T-scores, standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global physical health The Global Physical Health score is calculated by combining responses from survey questionnaire -- raw scores are converted to T-scores via scoring manuals.
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher T-scores indicate better
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Quality of Life - Mental

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0013
source section id
NCT04000880-om-0013
source outcome index
13
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Quality of Life - Mental
measure definition
Quality of life - mental is assessed using the PROMIS global health subscales measuring self-reported overall mental health, including emotional distress, psychological well-being, social satisfaction, and quality of life perceptions. The outcome measure is the resulting T-score standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global mental health
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher T-scores indicate better
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0014
source section id
NCT04000880-om-0014
source outcome index
14
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient reported' in the study's own wording
scale title
Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)
measure definition
Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Levels of Stress (Patient Reported Outcome)

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0015
source section id
NCT04000880-om-0015
source outcome index
15
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient reported' in the study's own wording
scale title
Levels of Stress (Patient Reported Outcome)
measure definition
Participants complete the 14-item Perceived Stress Scale (PSS-14), a validated self-report instrument that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. Each item is rated on a 5-point scale (0 = never to 4 = very often). Positively stated items are reverse scored, and item responses are summed to generate a raw total score (range: 0 to 56). The outcome measure is a T-score calculated using standard normalization procedures. Range = 0 to 100. Higher T-scores indicate greater perceived stress (worse outcome).
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
exploratory
reporting status
POSTED
higher is better
0
direction quote
Higher T-scores indicate greater perceived stress (worse
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Quality of Life - EQ-5D Index

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0021
source section id
NCT04000880-om-0021
source outcome index
21
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Quality of Life - EQ-5D Index
measure definition
Quality of life is assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument that measures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on 5 levels: No problems, Slight problems, Moderate problems, Severe problems and Extreme problems Responses are combined into a 5-digit health state, which is converted into a single summary index score. EQ-5D Index range: 0 to 1. Higher scores indicate better quality of life
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
Higher scores indicate better
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Cognitive Function

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0022
source section id
NCT04000880-om-0022
source outcome index
22
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Cognitive Function
measure definition
Cognitive Function is assessed using the PROMIS Cognitive Function Short Form 4a questionnaire, which evaluates memory, attention span, and concentration Outcome measure is a T-score, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive function
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
Higher T-scores indicate better
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Cognitive Abilities

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
qol key
qol-0023
source section id
NCT04000880-om-0023
source outcome index
23
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Cognitive Abilities
measure definition
Cognitive Ability is measured with PROMIS Cognitive Abilities - Short Form 8a, which evaluates perceived cognitive abilities, including memory, attention, concentration, and mental acuity. Outcome measure is reported as T-scores, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive abilities
time frame
Pre-intervention (Baseline), 12-month post-intervention
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
Higher T-scores indicate better
population note
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT04000880
trial label
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
8
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0000
    source section id
    NCT04000880-om-0000
    source outcome index
    0
    endpoint
    Dietary Quality (Healthy Eating Index)
    endpoint definition
    Participants completed two dietary recalls (one weekday and one weekend day) via telephone using a multipass method and the Nutrition Data Systems for Research (NDSR) software. The software averages the 2-day resulting data and calculates the Healthy Eating Index (HEI)-2015. The HEI indicates how closely someone's diet follows the Dietary Guidelines for Americans. The index range is 0 to 100 with an index closer to 100 indicating a healthier, well-balanced diet.
    time origin
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0001
    source section id
    NCT04000880-om-0001
    source outcome index
    1
    endpoint
    Body Weight
    endpoint definition
    Participant body weight will be measured during an in-person or remote (Zoom) visit
    time origin
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0002
    source section id
    NCT04000880-om-0002
    source outcome index
    2
    endpoint
    Physical Activity (Measured by Actigraphy)
    endpoint definition
    Physical activity will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.
    time origin
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0003
    source section id
    NCT04000880-om-0003
    source outcome index
    3
    endpoint
    Waist Circumference
    endpoint definition
    Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.
    time origin
    Pre-intervention (Baseline),12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0004
    source section id
    NCT04000880-om-0004
    source outcome index
    4
    endpoint
    Muscle Mass With Spillage Correction
    endpoint definition
    Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.
    time origin
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0005
    source section id
    NCT04000880-om-0005
    source outcome index
    5
    endpoint
    Percentage Muscle Mass With Spillage Correction
    endpoint definition
    Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates percentage of body weight that is muscle mass.
    time origin
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Project 1: Diet-Exercise
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    148
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Project 2: Exercise-Diet
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Project 3: Combined Diet and Exercise
    regimen
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    264
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Project 1: Diet-Exercise
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    148
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Project 2: Exercise-Diet
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Project 3: Combined Diet and Exercise
    regimen
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Project 1: Diet-Exercise
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Project 2: Exercise-Diet
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Project 3: Combined Diet and Exercise
    regimen
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Project 1: Diet-Exercise
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    128
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Project 2: Exercise-Diet
    regimen
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    129
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Project 3: Combined Diet and Exercise
    regimen
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    analyzed count
    220
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04000880-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    harm key
    EG000
    source section id
    NCT04000880-ae
    event group key
    EG000
    event group label
    Project 1: Diet-Exercise
    serious affected
    9
    serious at risk
    151
    other affected
    47
    other at risk
    151
    frequency threshold
    0
    collection period
    Adverse event data were collected from Baseline to 12-month period
    event definition
    The definitions of serious and non-serious adverse events were consistent with those used by ClinicalTrials.gov. but participants could report more than one adverse event, categories are not mutually exclusive.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    harm key
    EG001
    source section id
    NCT04000880-ae
    event group key
    EG001
    event group label
    Project 2: Exercise-Diet
    serious affected
    6
    serious at risk
    151
    other affected
    41
    other at risk
    151
    frequency threshold
    0
    collection period
    Adverse event data were collected from Baseline to 12-month period
    event definition
    The definitions of serious and non-serious adverse events were consistent with those used by ClinicalTrials.gov. but participants could report more than one adverse event, categories are not mutually exclusive.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    harm key
    EG002
    source section id
    NCT04000880-ae
    event group key
    EG002
    event group label
    Project 3: Combined Diet and Exercise
    serious affected
    10
    serious at risk
    301
    other affected
    46
    other at risk
    301
    frequency threshold
    0
    collection period
    Adverse event data were collected from Baseline to 12-month period
    event definition
    The definitions of serious and non-serious adverse events were consistent with those used by ClinicalTrials.gov. but participants could report more than one adverse event, categories are not mutually exclusive.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0011
    source section id
    NCT04000880-om-0011
    source outcome index
    11
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient reported' in the study's own wording
    scale title
    Physical Activity - Godin (Patient Reported Outcome)
    measure definition
    This physical activity outcome is measured using the Godin Leisure Time Physical Activity Questionnaire which asks frequency and duration of various levels of physical activity in a week period. The resulting outcome measure (minutes per week) is the Adjusted Godin Moderate-to-Vigorous Physical Activity (MVPA) score, calculated based on reported frequency and duration of moderate and strenuous (vigorous) leisure-time activities as follows: Adjusted Godin MVPA= (frequency \* duration of moderate activity) + 2 (frequency \* duration of vigorous activity)
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0012
    source section id
    NCT04000880-om-0012
    source outcome index
    12
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Quality of Life - Physical
    measure definition
    Quality of life - physical is assessed using the PROMIS global health subscales measuring self-reported overall physical health, including physical functioning, fatigue, pain, and general health perceptions. The outcome measure is the resulting T-scores, standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global physical health The Global Physical Health score is calculated by combining responses from survey questionnaire -- raw scores are converted to T-scores via scoring manuals.
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher T-scores indicate better
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0013
    source section id
    NCT04000880-om-0013
    source outcome index
    13
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Quality of Life - Mental
    measure definition
    Quality of life - mental is assessed using the PROMIS global health subscales measuring self-reported overall mental health, including emotional distress, psychological well-being, social satisfaction, and quality of life perceptions. The outcome measure is the resulting T-score standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global mental health
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher T-scores indicate better
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0014
    source section id
    NCT04000880-om-0014
    source outcome index
    14
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient reported' in the study's own wording
    scale title
    Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)
    measure definition
    Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0015
    source section id
    NCT04000880-om-0015
    source outcome index
    15
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient reported' in the study's own wording
    scale title
    Levels of Stress (Patient Reported Outcome)
    measure definition
    Participants complete the 14-item Perceived Stress Scale (PSS-14), a validated self-report instrument that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. Each item is rated on a 5-point scale (0 = never to 4 = very often). Positively stated items are reverse scored, and item responses are summed to generate a raw total score (range: 0 to 56). The outcome measure is a T-score calculated using standard normalization procedures. Range = 0 to 100. Higher T-scores indicate greater perceived stress (worse outcome).
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    0
    direction quote
    Higher T-scores indicate greater perceived stress (worse
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0021
    source section id
    NCT04000880-om-0021
    source outcome index
    21
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Quality of Life - EQ-5D Index
    measure definition
    Quality of life is assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument that measures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on 5 levels: No problems, Slight problems, Moderate problems, Severe problems and Extreme problems Responses are combined into a 5-digit health state, which is converted into a single summary index score. EQ-5D Index range: 0 to 1. Higher scores indicate better quality of life
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores indicate better
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0022
    source section id
    NCT04000880-om-0022
    source outcome index
    22
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Cognitive Function
    measure definition
    Cognitive Function is assessed using the PROMIS Cognitive Function Short Form 4a questionnaire, which evaluates memory, attention span, and concentration Outcome measure is a T-score, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive function
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher T-scores indicate better
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT04000880
    qol key
    qol-0023
    source section id
    NCT04000880-om-0023
    source outcome index
    23
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Cognitive Abilities
    measure definition
    Cognitive Ability is measured with PROMIS Cognitive Abilities - Short Form 8a, which evaluates perceived cognitive abilities, including memory, attention, concentration, and mental acuity. Outcome measure is reported as T-scores, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive abilities
    time frame
    Pre-intervention (Baseline), 12-month post-intervention
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher T-scores indicate better
    population note
    The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice