Trials / Completed

CompletedNCT03032250

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 35 (actual)

Sponsor: Wake Forest University Health Sciences · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
OTHER	Communication Intervention	Attend interventionist sessions
OTHER	Watch video	Watch video on a DVD
OTHER	Module completion of the Prepare to Care kit	Complete modules of the Prepare to Care kit
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Survey Administration	Ancillary studies
OTHER	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.

Timeline

Start date: 2017-05-15
Primary completion: 2020-04-10
Completion: 2020-04-10
First posted: 2017-01-26
Last updated: 2023-01-09
Results posted: 2021-07-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03032250. Inclusion in this directory is not an endorsement.