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

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

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

→

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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id: NCT03032250
trial label: Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
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: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
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