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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04255030
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Sylvie Lambert, St. Mary's Research Center, Canada

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.

Condition or disease Intervention/treatment Phase
Cancer Anxiety Behavioral: Coping Together Booklets and Workbook Behavioral: Cancer Chat online support Behavioral: Motivational Interviewing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: First stage: Self-directed Coping Together 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.

Experimental: First stage: Minimally guided Cancer Chat Support 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: Cancer Chat online support
Dyads will receive Coping-Together and participate in text-based, synchronous online groups led by a social worker (SW) and hosted by Cancer Chat Canada. This intervention capitalizes on an existing, acceptable, and feasible service to facilitate its integration into current infrastructure (if efficacious in larger SMART). This form of guidance was selected, as caregivers identify a need to connect with others through group interventions. In the first moderated group (duration = 60-90 minutes), SW will invite patients and caregivers to write about challenges and their use of Coping-Together to date. This first group will conclude with setting a goal to manage challenges for the next two weeks and developing an action plan. The subsequent two groups (duration = 60-90minutes each), over a four-week period, will focus on reviewing the use of the intervention and related barriers, offering advice to overcome these, and providing positive reinforcement.

Experimental: Second stage: High intensity Motivational Interviewing (MI) 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: 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.




Primary Outcome Measures :
  1. Consent and follow-up rates [ Time Frame: From recruitment launch to completion of follow-up (9 months) ]
    Number of consenting dyads per week over the recruitment period, with report on refusal and drop-out rates and reasons.

  2. Data completion rate [ Time Frame: At T2: 13 weeks ]
    Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.

  3. Fidelity of intervention delivery [ Time Frame: At T2: 13 weeks ]
    Checklists will be used to assess if the interventions are delivered as per protocol

  4. Adherence to intervention [ Time Frame: At T2: 13 weeks ]
    Rate of tool use and participation in the support sessions.

  5. Satisfaction with the intervention [ Time Frame: At T2: 13 weeks ]
    Using a modified satisfaction questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Both patients with cancer and their caregivers will be recruited in this study as a dyad.

Inclusion Criteria:

  • 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,

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255030


Contacts
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Contact: Sylvie Lambert, PhD 514 345 3511 ext 3074 sylvie.lambert@mcgill.ca
Contact: Manon de Raad manon.deraad@ssss.gouv.qc.ca

Locations
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Canada, Quebec
St Mary's Hospital Centre Recruiting
Montreal, Quebec, Canada, H3T1M5
Contact: Manon de Raad       manon.deraad@ssss.gouv.qc.ca   
Sponsors and Collaborators
St. Mary's Research Center, Canada
McGill University
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Responsible Party: Sylvie Lambert, Principal Scientist, St. Mary's Research Center, Canada
ClinicalTrials.gov Identifier: NCT04255030    
Other Study ID Numbers: SMHC 17 10
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sylvie Lambert, St. Mary's Research Center, Canada:
Caregiver
Self-directed interventions
Coping
Self-management
Stepped care
Psychosocial oncology
Cancer
Sequential Multiple Assignment Randomized Trial (SMART)