Clinical trial NCT04255030: An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Anxiety
Keywords: Caregiver
Self-directed interventions
Coping
Self-management
Stepped care
Psychosocial oncology
Cancer
Sequential Multiple Assignment Randomized Trial (SMART)
Lead sponsor: St. Mary's Research Center, Canada
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2020-02-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: BACKGROUND: Despite improvements in detection and treatment, a cancer diagnosis is appraised as a negative event not only by the person diagnosed, but also by their family caregivers. Cancer is the second most common condition in Canada requiring assistance from caregivers, and caregivers are now taking on more than ever complex illness management roles traditionally performed by health care professionals (HCPs). This is in part attributed to the cost containment climate of the current health care system; there is an increased reliance on community-based care to manage the burden of cancer care on formal care settings. Caregivers' support reduces demands on the formal health care system and positively impacts on patients' adjustment. However, caregivers often take on their roles with little formal support. This results in high anxiety and low quality of life (QOL). In recognition of this, numerous interventions have been developed and found to be efficacious in reducing caregivers' anxiety and increasing their QOL. Unfortunately, these interventions are often time- and resource-intensive, making them too costly for integration in routine care. As more sustainable modes of intervention delivery are required, one format that holds promise is to use a self-directed format (i.e., low-intensity intervention). However, previous research by the team has shown that up to 60% of caregivers do not respond to these types of interventions alone and require additional support. An innovative trial design to developing time-varying, adaptive interventions to maximize clinical effectiveness is the Sequential multiple assignment randomized trials (SMARTs). However, despite increasing popularity, SMARTs remain relatively new to intervention researchers.

OBJECTIVES: The goal of this pilot SMART is to inform the planning of a subsequent larger SMART to evaluate an adaptive dyadic coping and self-management skill training intervention that follows a stepped-care model for caregivers of individuals with cancer. The primary objective of this pilot SMART is to examine the (a) feasibility of the trial procedures and of offering different levels and types of support alongside a self-directed coping and self-management skills training intervention and (b) acceptability of the combinations of the intervention according to patients and their caregivers. The secondary objective is to estimate the clinical significance of adapting the type and level of support provided on the primary and secondary outcomes.

METHODOLOGY: Study activities will be coordinated out of St Mary's Research Centre in Montreal. Weekly, at the McGill University Health Centre (MUHC), St. Mary's Hospital Center, and Ottawa Hospital, a research assistant (RA), along with the treating clinician, will screen new patient records and identify those who meet the medical inclusion criteria. At the time of their scheduled appointment, clinicians will introduce the study to eligible patients and obtain permission for a RA to approach them. The RA will then either complete the screening interview with patients and their caregivers on site, or follow up by telephone to complete the interview. Those eligible will be emailed the link to the consent form and baseline (T0) questionnaire. At BC Cancer Agency and Princess Margaret Cancer Care Centre, posters will be displayed and patients/caregivers will be informed of the study by the Patient and Family Counseling Services team and other health care team members. Patients will be invited to self-refer by calling the RA directly using the toll free number provided. Community-based recruitment will include advertising the study through social media. This strategy will be led by the Environics Research Group who recruited participants for a previous CIHR team grant.

Investigators aim to recruit 56 patients with a primary breast, prostate, or colorectal cancer diagnosis in the previous 6 months.

Inclusion criteria are:

* receiving/planning to receive treatment,
* having a caregiver willing to participate
* access to the internet,
* patient or caregiver screening positive for anxiety.

Patient-caregiver dyads returning their consent forms and baseline questionnaires (T0) will be randomized by the study coordinator to either: (a) Coping-Together - a 6-week self-directed, dyadic coping and self-management skills training intervention or (b) Coping-Together plus brief, weekly lay telephone coaching. At the end of 6 weeks, intervention response will be assessed by the RA (T1) based on the change in patients' and caregivers' anxiety (primary tailoring variable). Across both groups, non-responders will then be randomized a second time to either (a) continue with their first stage intervention or (b) begin telephone-based self-management counseling for another 6 weeks (either with a lay coach if self-directed for the first six weeks or with a health professional if coached for the first six weeks). Responders will continue with usual care. All participants will then complete their follow-up questionnaire (T2) to examine changes in anxiety and QOL (primary outcomes), depression, self-management skills, illness appraisal, and coping (secondary outcomes). Acceptability will also be assessed in this questionnaire and further explored during an exit interview with dyads. Feasibility measures will focus on the characteristics of the dyads reached, protocol fidelity, percent of missing data, and recruitment and retention rates.

SIGNIFICANCE: The ability of caregivers to maintain their QOL despite the stressors they face is undermined by limited access to the support needed. This study will develop and evaluate the first adaptive interventions for this population, and address a significant research gap by documenting its acceptability, feasibility, and clinical significance. Despite advocacy for caregiver support, no other Canadian study has examined how potentially cost-effective interventions can be combined to meet caregivers' needs. Collaboration with six cancer centers will accelerate the uptake of findings.

Eligibility 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

Primary outcomes:
measure: Consent and follow-up rates
timeFrame: From recruitment launch to completion of follow-up (9 months)
measure: Data completion rate
timeFrame: At T2: 13 weeks
measure: Fidelity of intervention delivery
timeFrame: At T2: 13 weeks
measure: Adherence to intervention
timeFrame: At T2: 13 weeks
measure: Satisfaction with the intervention
timeFrame: At T2: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St Mary's Hospital Centre
state: Quebec
Study officials:
References: