An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer

NCT04255030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-10-26

No results posted yet for this study

Summary

High-quality cancer care in Canada relies on family caregivers. Since cancer treatment is provided more and more in outpatient clinics, family caregivers now provide most of the support and care patients need when they return home. The problem is that caregivers often do not feel they have the knowledge and skills to fulfill this role, especially as caregivers often confront tasks once performed by health care professionals. As a result, caregivers experience high levels of burden and need more help to handle the demands of their role. Programs that enhance caregivers' knowledge and prepare them for their role can have positive effects on their well-being. However, these programs are not available in routine cancer care. They just take too much time and personnel and are too expensive. This limited access to resources reduces caregivers' ability to cope and affects their quality of life. If the ultimate goal is to integrate these programs in cancer care, cost-effective service delivery models are needed. One approach that rises to this challenge and is effective is the self-directed format. A self-directed format requires less support from clinicians and is available to individuals when it is most convenient to them. The research team recently developed and evaluated the first self-directed coping skills training intervention for cancer caregivers called Coping-Together. Although self-directed interventions offer the scalability needed for public health interventions, up to 60% of caregivers do not improve after receiving this type of intervention. These caregivers require more support. This innovative trial design will help determine whether changing the type and level of support provided can increase the number of caregivers who improve after receiving Coping-Together. This type of innovative trial design is more and more popular, but has never been used to enhance the feasibility, acceptability, and efficacy of caregiver interventions.

Conditions

Interventions

BEHAVIORAL

Coping Together Booklets and Workbook

Dyads in this group will complete Coping-Together, a 6-week, booklet-based, self-directed coping and self-management skills training intervention. This intervention addresses key psychosocial challenges by offering evidence-based practical skills to: (a) manage symptoms, (b) cope with anxiety, (c) collaborate with the health care team, (d) engage in shared decision-making, (e) communicate with partner and family, and/or (f) obtain the community resources needed. A relaxation CD is also included, in addition to a workbook that accompanies the Coping-Together booklet-based intervention. The workbook aims at helping dyads choose a booklet relevant to their cancer-related challenges faced, find coping skills that best meet these challenges, and make a plan to use one of the coping skills successfully.

BEHAVIORAL

Lay telephone coaching

Dyads will receive Coping-Together support via weekly telephone calls from a lay coach. Sessions will range between 10-15 minutes. The goal of coaching will be to provide information on how to use the workbook and booklets. Although no formal therapy will be provided, the coach will maintain a positive and encouraging attitude when interacting with participants regardless of their adherence to the intervention recommendations. The sessions will start with the coach setting a predetermined agenda based on the section of the workbook to review that week that week. Then, coaches will ask about the use of the booklets over the previous week, and ask participants about any required support or clarification in using the booklets. Sessions conclude with setting a goal related to the workbook, booklets and/or coping technique to focus on over the coming week.

BEHAVIORAL

Motivational Interviewing

Six, 45-60 minute weekly telephone-based sessions with a trained Motivational Interviewing Specialist to progress toward goals. Here, dyads are given one-on-one guidance from a HCP Motivational Interviewing Specialist to practice the skills they need. Calls will focus on problem-solving principles and core components of self-management (70), including: (a) identifying dyads' concerns, (b) reviewing management efforts, (c) identifying goals, (d) identifying skills needed to achieve goals, and (e) addressing barriers to applying skills to current situations, including level of self-efficacy. At each meeting, progress, subsequent goals, and corresponding plans will be discussed.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-08-18
Completion
2022-08-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255030 on ClinicalTrials.gov