Trial Outcomes & Findings for Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer (NCT NCT03032250)
NCT ID: NCT03032250
Last Updated: 2023-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Six weeks post radiation therapy
Results posted on
2023-01-09
Participant Flow
Participant milestones
| Measure |
Group I Supportive Care (Prepare to Care Kit)
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.
|
Group II Control Group
Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
Baseline characteristics by cohort
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II Control Group
n=18 Participants
Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study."
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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 15.5 • n=39 Participants
|
57.4 years
STANDARD_DEVIATION 11.8 • n=41 Participants
|
56.4 years
STANDARD_DEVIATION 13.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=39 Participants
|
18 participants
n=41 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Six weeks post radiation therapy10-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.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
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.
|
|---|---|---|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Introductory DVD
|
4 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Meetings with study interventionist
|
6 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Relaxation CD
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Weekly text reminders
|
6 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Weekly email reminders
|
4 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Study website
|
0 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Clinic iPads
|
0 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Cancer Education workbook
|
9 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Utilizing Resources workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Managing Time workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Seeking/Accepting Support workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Communicating with Others workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Healthy Behaviors workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Positive Coping workbook
|
7 Participants
|
—
|
|
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Muscle Relaxation workbook
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: 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
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=38 Participants
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.
|
Group II No Interventionist Sessions
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.
|
|---|---|---|
|
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
|
1.7 participants/months
|
—
|
PRIMARY outcome
Timeframe: Baseline and following radiotherapy, assessed up to 1 yearPopulation: Not all participants submitted information after completion of radiotherapy.
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.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
n=18 Participants
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.
|
|---|---|---|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on health at baseline
|
13.94 score on a scale
Standard Deviation 1.48
|
13.67 score on a scale
Standard Deviation 1.65
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Esteem at baseline
|
25.98 score on a scale
Standard Deviation 3.6
|
25.88 score on a scale
Standard Deviation 3.8
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Lack of family support at baseline
|
11.29 score on a scale
Standard Deviation 2.69
|
11.25 score on a scale
Standard Deviation 2.67
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on finances at baseline
|
8.29 score on a scale
Standard Deviation 2.28
|
8.89 score on a scale
Standard Deviation 1.78
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on schedule at baseline
|
17.35 score on a scale
Standard Deviation 3.31
|
16.78 score on a scale
Standard Deviation 4.1
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Esteem after radiotherapy
|
25.75 score on a scale
Standard Deviation 3.31
|
25.30 score on a scale
Standard Deviation 4.19
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Lack of family support after radiotherapy
|
12.58 score on a scale
Standard Deviation 2.23
|
11.19 score on a scale
Standard Deviation 3.23
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on finances after radiotherapy
|
8.42 score on a scale
Standard Deviation 1.16
|
8.25 score on a scale
Standard Deviation 1.24
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on schedule after radiotherapy
|
18.33 score on a scale
Standard Deviation 2.74
|
16.56 score on a scale
Standard Deviation 4.43
|
|
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Impact on health after radiotherapy
|
14.33 score on a scale
Standard Deviation 1.61
|
14.38 score on a scale
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: Before and after radiotherapy, assessed up to 1 yearPopulation: Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure
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.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
n=18 Participants
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.
|
|---|---|---|
|
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
Score at baseline
|
19.71 score on a scale
Standard Deviation 13.05
|
19.28 score on a scale
Standard Deviation 12.97
|
|
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
Score after radiotherapy
|
19.00 score on a scale
Standard Deviation 15.66
|
13.58 score on a scale
Standard Deviation 8.65
|
PRIMARY outcome
Timeframe: Before and after radiotherapy, assessed up to 1 yearPopulation: Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
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.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
n=17 Participants
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.
|
|---|---|---|
|
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
At baseline
|
87.63 score on a scale
Standard Deviation 25.95
|
87.26 score on a scale
Standard Deviation 20.32
|
|
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
After radiotherapy
|
92.55 score on a scale
Standard Deviation 22.09
|
89.86 score on a scale
Standard Deviation 18.78
|
PRIMARY outcome
Timeframe: Up to 1 yearData on intervention resources used and time spent using them based on caregivers in intervention group
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
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.
|
|---|---|---|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Cancer Education
|
22.3 Minutes
Standard Deviation 10.2
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Utilizing Resources
|
38.7 Minutes
Standard Deviation 20.1
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Seeking/ Accepting Support
|
55.2 Minutes
Standard Deviation 27.8
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Communicating with others
|
40.3 Minutes
Standard Deviation 12.7
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Managing Time
|
40.8 Minutes
Standard Deviation 26.9
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Coping
|
66.7 Minutes
Standard Deviation 51.1
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Practicing Healthy Behaviors
|
48 Minutes
Standard Deviation 15.6
|
—
|
|
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Relaxation CD
|
58 Minutes
Standard Deviation 18.1
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: 90 eligible patient/caregiver dyads, 38 agreed to participate
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=90 Participants
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.
|
Group II No Interventionist Sessions
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.
|
|---|---|---|
|
Number of Participants in Agreement to Perform Interventions
|
38 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: 38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=38 Participants
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.
|
Group II No Interventionist Sessions
n=38 Participants
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.
|
|---|---|---|
|
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
|
12 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: At baseline and up to the end of radiotherapy, assessed up to 1 yearA 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
n=18 Participants
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.
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|---|---|---|
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Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
At baseline
|
11.88 score on a scale
Standard Deviation 6.53
|
13.33 score on a scale
Standard Deviation 5.36
|
|
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
After radiotherapy
|
16.08 score on a scale
Standard Deviation 2.68
|
12.19 score on a scale
Standard Deviation 5.59
|
PRIMARY outcome
Timeframe: At baseline and up to the end of radiotherapy, assessed up to 1 year21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
Outcome measures
| Measure |
Group I Supportive Care (Prepare to Care Kit)
n=17 Participants
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.
|
Group II No Interventionist Sessions
n=18 Participants
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.
|
|---|---|---|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Managing medical information at baseline
|
22.35 score on a scale
Standard Deviation 3.26
|
22.00 score on a scale
Standard Deviation 3.29
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Caring for care recipient at baseline
|
52.94 score on a scale
Standard Deviation 9.65
|
55.11 score on a scale
Standard Deviation 6.11
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Caring for oneself at baseline
|
25.71 score on a scale
Standard Deviation 10.44
|
28.06 score on a scale
Standard Deviation 7.83
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Managing difficult interactions/emotions at baseline
|
34.52 score on a scale
Standard Deviation 10.96
|
39.13 score on a scale
Standard Deviation 7.95
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Managing medical information after radiotherapy
|
23.08 score on a scale
Standard Deviation 2.54
|
22.43 score on a scale
Standard Deviation 4.80
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Caring for care recipient after radiotherapy
|
54.42 score on a scale
Standard Deviation 5.62
|
54.98 score on a scale
Standard Deviation 6.82
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Caring for oneself after radiotherapy
|
25.75 score on a scale
Standard Deviation 9.40
|
31.30 score on a scale
Standard Deviation 8.26
|
|
Self-efficacy in Coping With Cancer Caregiver Inventory
Managing difficult interactions/emotions after radiotherapy
|
37.92 score on a scale
Standard Deviation 10.03
|
39.68 score on a scale
Standard Deviation 7.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available.
For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3
Outcome measures
Outcome data not reported
Adverse Events
Group I Supportive Care (Prepare to Care Kit)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-1432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place