Clinical trial · Interventional
An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coping Together Booklets and Workbook | Behavioral | — | UNRESOLVED |
| Lay telephone coaching | Behavioral | — | UNRESOLVED |
| Motivational Interviewing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- First stage: Self-directed Coping Together
- interventionNames
- Behavioral: Coping Together Booklets and Workbook
- type
- EXPERIMENTAL
- label
- First stage: Minimally guided telephone support (lay coaching)
- interventionNames
- Behavioral: Coping Together Booklets and Workbook
- Behavioral: Lay telephone coaching
- type
- EXPERIMENTAL
- label
- Second stage: High intensity Motivational Interviewing (MI)
- interventionNames
- Behavioral: Coping Together Booklets and Workbook
- Behavioral: Motivational Interviewing
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWiesenfeld 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
- DERIVEDLambert 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