NCT04000880 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2026-07-02

This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Dietary Quality (Healthy Eating Index)

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outcome · POSTED

Body Weight

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outcome · POSTED

Physical Activity (Measured by Actigraphy)

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outcome · POSTED

Waist Circumference

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outcome · POSTED

Muscle Mass With Spillage Correction

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outcome · POSTED

Percentage Muscle Mass With Spillage Correction

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outcome · POSTED

30 Second Chair Stand

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outcome · POSTED

8' Get up and go

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outcome · POSTED

2-minute Step Test

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outcome · POSTED

Chair Sit and Reach

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outcome · POSTED

Back Scratch

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outcome · POSTED

Physical Activity - Godin (Patient Reported Outcome)

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outcome · POSTED

Quality of Life - Physical

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outcome · POSTED

Quality of Life - Mental

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outcome · POSTED

Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)

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outcome · POSTED

Levels of Stress (Patient Reported Outcome)

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outcome · POSTED

Circulating Biomarkers "Cholesterol"

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outcome · POSTED

Circulating Biomarkers "HDL"

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outcome · POSTED

Circulating Biomarkers "Triglyceride"

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outcome · POSTED

Circulating Biomarkers "Glucose"

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outcome · POSTED

Circulating Biomarkers " C-reactive Protein"

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outcome · POSTED

Quality of Life - EQ-5D Index

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outcome · POSTED

Cognitive Function

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outcome · POSTED

Cognitive Abilities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Age 50 years or older * Resident of the continental United States * Diagnosed with multiple myeloma, non-Hodgkin lymphoma, or localized kidney or ovarian cancer; or \[localized (includes in situ) through regional\] breast, colorectum, endometrium, thyroid, or prostate cancer. * Completed primary treatment (surgery, radiation or chemotherapy). Active surveillance among men with prostate cancer or women with ductal carcinoma in situ is acceptable. * Completion of the 8th grade of school. Able to read and write English. * Normal blood pressure or those with high blood pressure for whom physician permission was granted. * Community dwelling. * Reside in an area that receives wireless coverage. * Have an active email address or be willing to have one created for the study. * Current body mass index of greater than or equal to 25 kg/m2, but less than 50 kg/m2. * Current physical activity level is less than 150 minutes of moderate-to-vigorous exercise per week. Exclusion Criteria: * Participation in another diet and exercise program. * Evidence of progressive cancer of the eligible types. * Recurrence of the eligible cancer types (exceptions are biochemical recurrence of prostate cancer). * A physician has provided instruction to limit current physical activity. * Pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention (e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months). * Second primary cancers, with the exception of non-melanoma skin cancer, or if the initial and second cancers are both deemed eligible cancers. * Reside in a skilled nursing or assisted living facility.
healthy Volunteers: false
minimum Age: 50 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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).
intervention Names
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Other: Combined Diet and Exercise
label
Project 1: Diet-Exercise
type
EXPERIMENTAL
description
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).
intervention Names
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Other: Combined Diet and Exercise
label
Project 2: Exercise-Diet
type
EXPERIMENTAL
description
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).
intervention Names
Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Other: Diet-Exercise
Other: Exercise-Diet
label
Project 3: Combined Diet and Exercise
type
EXPERIMENTAL

interventions

arm Group Labels
Project 1: Diet-Exercise
Project 2: Exercise-Diet
Project 3: Combined Diet and Exercise
description
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
name
Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
other Names
AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health
type
BEHAVIORAL
arm Group Labels
Project 3: Combined Diet and Exercise
description
Diet-Exercise
name
Diet-Exercise
type
OTHER
arm Group Labels
Project 3: Combined Diet and Exercise
description
Exercise-Diet
name
Exercise-Diet
type
OTHER
arm Group Labels
Project 1: Diet-Exercise
Project 2: Exercise-Diet
description
Combined Diet and Exercise
name
Combined Diet and Exercise
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

Participants will participate in one of three arms: 1. Diet followed by Exercise intervention 2. Exercise followed by Diet intervention 3. Combined Diet and Exercise intervention

masking Info

masking: TRIPLE
masking Description: Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not.
who Masked: CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 603
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
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).
measure
Levels of Stress (Patient Reported Outcome)
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
Circulating cholesterol levels are assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots are dried and stored according to standard protocols, and DBS eluents are batch-tested against known standards to determine cholesterol concentrations. This outcome measure is the measure of mg/dl of total cholesterol
measure
Circulating Biomarkers "Cholesterol"
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
High-density lipoprotein (HDL) cholesterol will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine HDL cholesterol. Outcome measure is mg/dL of HDL Range (adults): typically, 20 to 100 mg/dL Higher HDL cholesterol indicates a better (protective) cardiovascular outcome.
measure
Circulating Biomarkers "HDL"
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
Triglyceride levels are assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots are dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine triglyceride concentrations. Outcome measure is mg/dL of triglyceride concentration Range:50 to 500 mg/dL (adults) Higher triglyceride levels indicate a worse (higher cardiovascular risk) outcome
measure
Circulating Biomarkers "Triglyceride"
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
Fasting glucose levels will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine glucose concentrations. Outcome measure is mg/dL of glucose concentration Range:70 to 200 mg/dL (adults) Higher fasting glucose levels indicate a worse metabolic outcome (greater risk of impaired glucose regulation or diabetes).
measure
Circulating Biomarkers "Glucose"
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
C-reactive protein (CRP) levels will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine CRP concentrations. Range: (0.1 to 10 mg/DL) in adults (higher values may occur with acute inflammation) Higher CRP levels indicate greater systemic inflammation and a worse health outcome
measure
Circulating Biomarkers " C-reactive Protein"
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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
measure
Quality of Life - EQ-5D Index
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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
measure
Cognitive Function
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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
measure
Cognitive Abilities
time Frame
Pre-intervention (Baseline), 12-month post-intervention

primary Outcomes

description
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.
measure
Dietary Quality (Healthy Eating Index)
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
Participant body weight will be measured during an in-person or remote (Zoom) visit
measure
Body Weight
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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.
measure
Physical Activity (Measured by Actigraphy)
time Frame
Pre-intervention (Baseline), 12-month post-intervention

secondary Outcomes

description
Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.
measure
Waist Circumference
time Frame
Pre-intervention (Baseline),12-month post-intervention
description
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.
measure
Muscle Mass With Spillage Correction
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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.
measure
Percentage Muscle Mass With Spillage Correction
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
In this physical performance test the participant is instructed to sit and stand as many times as they can while crossing their arms against their shoulders for 30 seconds. the outcomes measure is the number of times participants sit and stand in 30 seconds.
measure
30 Second Chair Stand
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
In this performance test we instruct participants to start from a seated position, cross their arms against their shoulder, then, when instructed, they stand walk around the cone and come back to a seated position. The outcome measure is the number of seconds from start to end of the walk
measure
8' Get up and go
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
In this performance test, participants are instructed to step in place for 2 minutes. The outcomes measure is the number of steps within the two minutes that reach a certain height. This height is determined measuring first the distance from hip joint to top of knee, taking the half of that distance and applying it from the floor marking a that height on a wall or door frame with a sticker. Assessors spot and count steps that reach or exceed the sticker mark on the wall (every other step is counted)
measure
2-minute Step Test
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
This physical performance test is done as follows: * Participant sits on the edge of a chair, with one leg is extended straight forward with the heel on the floor and ankle at \~90°.(The other leg remains bent with the foot flat on the floor). * Participant's hands are placed one on top of the other, and participant slowly reaches forward toward the toes of the extended leg (the test is performed on both legs, and assessor selects the most flexible side) * The outcome measure is the distance in cm from the closest finger and toe. 0 inches → fingertips touch the toe Negative (-) → Participant cannot reach toes Positive (+) → Participant reaches past toes
measure
Chair Sit and Reach
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
This physical performance test of flexibility is done as follows: \- Participant stands upright and reach one hand over the shoulder and the other up the middle of the back, attempting to touch or overlap middle fingers (both sides are tried - right over left, then left over right). Outcome measure is the distance between the closest fingers (most flexible side is recorded) Scoring: 0 inches → fingertips just touch Negative (-) → fingers do not touch (gap distance) Positive (+) → fingers overlap (amount of overlap)
measure
Back Scratch
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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)
measure
Physical Activity - Godin (Patient Reported Outcome)
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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.
measure
Quality of Life - Physical
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
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
measure
Quality of Life - Mental
time Frame
Pre-intervention (Baseline), 12-month post-intervention
description
Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.
measure
Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)
time Frame
Pre-intervention (Baseline), 12-month post-intervention

Full study description

brief Summary: This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.
detailed Description: For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline (pre-intervention), 6-, 12 (post-intervention)- and 18- months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm will be evaluated at baseline (pre-intervention), 6-, 12 (post-intervention)-, and 18- months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin. It is hypothesized that cancer survivors assigned to all three of these study arms will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.

Source references

references

citation
Pekmezi D, Fontaine K, Rogers LQ, Pisu M, Martin MY, Schoenberger-Godwin YM, Oster RA, Kenzik K, Ivankova NV, Demark-Wahnefried W. Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. BMC Cancer. 2022 Apr 29;22(1):471. doi: 10.1186/s12885-022-09519-y.
pmid
35488238
type
BACKGROUND
citation
Ivankova NV, Rogers LQ, Herbey II, Martin MY, Pisu M, Pekmezi D, Thompson L, Schoenberger-Godwin YM, Oster RA, Fontaine K, Anderson JL, Kenzik K, Farrell D, Demark-Wahnefried W. Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study. JMIR Cancer. 2021 Oct 6;7(4):e26226. doi: 10.2196/26226.
pmid
34612832
type
RESULT
citation
Pisu M, Omairi I, Hoenemeyer T, Halilova KI, Schoenberger YM, Rogers LQ, Kenzik KM, Oster RA, Ivankova NV, Pekmezi D, Fontaine K, Demark-Wahnefried W, Martin MY. Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team. Contemp Clin Trials. 2021 Dec;111:106604. doi: 10.1016/j.cct.2021.106604. Epub 2021 Oct 29.
pmid
34757221
type
RESULT
citation
Rogers LQ, Pekmezi D, Schoenberger-Godwin YM, Fontaine KR, Ivankova NV, Kinsey AW, Hoenemeyer T, Martin MY, Pisu M, Farrell D, Wall J, Waugaman K, Oster RA, Kenzik K, Winters-Stone K, Demark-Wahnefried W. Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Digit Health. 2023 Jun 26;9:20552076231182805. doi: 10.1177/20552076231182805. eCollection 2023 Jan-Dec.
pmid
37434730
type
RESULT
citation
Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.
pmid
36971688
type
DERIVED