Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04255030
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2019-11-01
Brief Title:
An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer
Sponsor:
St Marys Research Center Canada
Organization:
St Marys Research Center Canada
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 Marys Research Centre in Montreal Weekly at the McGill University Health Centre MUHC St Marys 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 patientscaregivers 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
receivingplanning 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
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 Marys Research Centre in Montreal Weekly at the McGill University Health Centre MUHC St Marys 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 patientscaregivers 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
receivingplanning 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None