Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT03032250
This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
PRIMARY OBJECTIVES:
I. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).
II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).
III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.
IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Caregivers watch introduction video on a digital video disc (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.
GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
CAREGIVERS:
CARE-RECIPIENTS:
Exclusion criteria
Attend interventionist sessions
Watch video on a DVD
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete modules of the Prepare to Care kit
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
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.
Time frame: Six weeks post radiation therapy
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 frame: Up to 1 year
38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
Time frame: Baseline and following radiotherapy, assessed up to 1 year
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 frame: Before and after radiotherapy, assessed up to 1 year
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 frame: Before and after radiotherapy, assessed up to 1 year
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: Up to 1 year
Data on intervention resources used and time spent using them based on caregivers in intervention group
Time frame: Up to 1 year
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Time frame: Up to 1 year
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
A 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.
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
21-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.
Time frame: Up to 1 year
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
Wake Forest University Health Sciences
Other
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
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