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NCT03032250 · STUDY IN CONTEXT

Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.

Source null

→

primary · POSTED

38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month

38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month

→

primary · POSTED

21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.

Not all participants submitted information after completion of radiotherapy.

→

primary · POSTED

The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.

Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure

→

primary · POSTED

35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.

Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.

→

primary · POSTED

Data on intervention resources used and time spent using them based on caregivers in intervention group

Source null

→

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

Unnamed quality-of-life measure · Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)

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-laryngeal-cancer-locally-advanced-33e41c9f
nct id
NCT03032250
qol key
qol-0004
source section id
NCT03032250-om-0004
source outcome index
4
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
measure definition
35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
time frame
Before and after radiotherapy, assessed up to 1 year
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
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-laryngeal-cancer-locally-advanced-33e41c9f
nct id
NCT03032250
trial label
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0000
    source section id
    NCT03032250-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
    endpoint definition
    10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
    time origin
    Six weeks post radiation therapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0001
    source section id
    NCT03032250-om-0001
    source outcome index
    1
    endpoint
    Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
    endpoint definition
    38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0002
    source section id
    NCT03032250-om-0002
    source outcome index
    2
    endpoint
    Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
    endpoint definition
    21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
    time origin
    Baseline and following radiotherapy, assessed up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Not all participants submitted information after completion of radiotherapy.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0003
    source section id
    NCT03032250-om-0003
    source outcome index
    3
    endpoint
    Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
    endpoint definition
    The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
    time origin
    Before and after radiotherapy, assessed up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0004
    source section id
    NCT03032250-om-0004
    source outcome index
    4
    endpoint
    Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
    endpoint definition
    35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
    time origin
    Before and after radiotherapy, assessed up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0005
    source section id
    NCT03032250-om-0005
    source outcome index
    5
    endpoint
    Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
    endpoint definition
    Data on intervention resources used and time spent using them based on caregivers in intervention group
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group I Supportive Care (Prepare to Care Kit)
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Participants
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group I Supportive Care (Prepare to Care Kit)
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Group II No Interventionist Sessions
    regimen
    Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group I Supportive Care (Prepare to Care Kit)
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Group II No Interventionist Sessions
    regimen
    Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0003#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Group I Supportive Care (Prepare to Care Kit)
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0004#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Group II No Interventionist Sessions
    regimen
    Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0004#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Group I Supportive Care (Prepare to Care Kit)
    regimen
    Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03032250-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    harm key
    EG000
    source section id
    NCT03032250-ae
    event group key
    EG000
    event group label
    Group I Supportive Care (Prepare to Care Kit)
    serious affected
    0
    serious at risk
    17
    other affected
    0
    other at risk
    17
    frequency threshold
    0
    collection period
    6 weeks
    event definition
    Source null
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    harm key
    EG001
    source section id
    NCT03032250-ae
    event group key
    EG001
    event group label
    Group II Control Group
    serious affected
    0
    serious at risk
    18
    other affected
    0
    other at risk
    18
    frequency threshold
    0
    collection period
    6 weeks
    event definition
    Source null
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT03032250
    qol key
    qol-0004
    source section id
    NCT03032250-om-0004
    source outcome index
    4
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
    measure definition
    35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
    time frame
    Before and after radiotherapy, assessed up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
    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