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

NCT04255030 | Completed

• 1 other identifier: SMHC 17 10
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Cancer; Anxiety

Keywords

Caregiver; Self-directed interventions; Coping; Self-management; Stepped care; Psychosocial oncology; Cancer; Sequential Multiple Assignment Randomized Trial (SMART)

Outcome Measures

Primary Outcomes (5)

• Consent and follow-up rates

  Number of consenting dyads per week over the recruitment period, with report on refusal and drop-out rates and reasons.

  From recruitment launch to completion of follow-up (9 months)

• Data completion rate

  Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.

  At T2: 13 weeks

• Fidelity of intervention delivery

  Checklists will be used to assess if the interventions are delivered as per protocol

  At T2: 13 weeks

• Adherence to intervention

  Rate of tool use and participation in the support sessions.

  At T2: 13 weeks

• Satisfaction with the intervention

  Using a modified satisfaction questionnaire

  At T2: 13 weeks

Study Arms (3)

First stage: Self-directed Coping Together

EXPERIMENTAL

Behavioral: Coping Together Booklets and Workbook

First stage: Minimally guided telephone support (lay coaching)

EXPERIMENTAL

Behavioral: Coping Together Booklets and Workbook; Behavioral: Lay telephone coaching

Second stage: High intensity Motivational Interviewing (MI)

EXPERIMENTAL

Behavioral: Coping Together Booklets and Workbook; Behavioral: Motivational Interviewing

Interventions

Coping Together Booklets and Workbook BEHAVIORAL

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.

First stage: Minimally guided telephone support (lay coaching); First stage: Self-directed Coping Together; Second stage: High intensity Motivational Interviewing (MI)

Lay telephone coaching BEHAVIORAL

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.

First stage: Minimally guided telephone support (lay coaching)

Motivational Interviewing BEHAVIORAL

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.

Second stage: High intensity Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stages I-III primary breast, prostate, or colorectal cancer diagnosis within the past 6 months
• receiving/planning to receive treatment (including surgery, radiotherapy, chemotherapy, and/or hormone therapy)
• nominates a caregiver (spouse, partner, or other family member) willing to participate
• patient and or caregiver with low-moderate anxiety at recruitment
• regular access to a computer with internet and e-mail capabilities,

You may not qualify if:

• caregiver receiving treatment for cancer
• patient or caregiver is hospitalized
• or has suicidal intent,
• or is receiving psychological treatment
• or has in the past 6 months participated in a coping or self-management program
• or has severe anxiety
• or has moderate-severe cognitive impairment

Sponsors & Collaborators

• St. Mary's Research Center, Canada: lead
• McGill University: collaborator

Study Sites (1)

St Mary's Hospital Centre

Montreal, Quebec, H3T1M5, Canada

Location

Related Publications (2)

• Wiesenfeld S, Lambert S, Laizner AM. A stepped-care approach to self-management: a qualitative study among individuals with cancer and their caregivers using the Coping-Together program. Support Care Cancer. 2025 Feb 10;33(3):170. doi: 10.1007/s00520-025-09175-5.

  PMID: 39928172 DERIVED

• Lambert S, Moodie EEM, McCusker J, Lokhorst M, Harris C, Langmuir T, Belzile E, Laizner AM, Brahim LO, Wasserman S, Chehayeb S, Vickers M, Duncan L, Esplen MJ, Maheu C, Howell D, de Raad M. Translating Evidence-Based Self-Management Interventions Using a Stepped-Care Approach for Patients With Cancer and Their Caregivers: A Pilot Sequential Multiple Assignment Randomized Trial Design. Psychooncology. 2025 Jan;34(1):e70043. doi: 10.1002/pon.70043.

  PMID: 39763142 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: February 5, 2020
• Study Start: November 1, 2019
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)