Peer Caregiver Navigation for Family Caregivers in Oncology
Peer Caregiver Navigation (PCN) for Family Caregivers in Outpatient Oncology
| Sponsors |
Lead Sponsor: Washington University School of Medicine Collaborator: National Center for Advancing Translational Science (NCATS) |
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| Source | Washington University School of Medicine |
| Brief Summary | This clinical trial assesses the feasibility and acceptability of the psychosocial intervention peer caregiver navigation (PCN) in an outpatient oncology setting. PCN is a peer mentoring service designed to help family caregivers navigate and mitigate the distress of caregiving by enhancing and promoting the emotional and behavioral coping efforts of the caregiver. |
| Detailed Description | This study will provide data to inform future efficacy testing and implementation of psychosocial interventions for family caregivers, and may advance health equity by enhancing the ability to scale-up supportive care interventions for family caregivers, especially those in geographically underserved areas. |
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| Overall Status | Not yet recruiting | ||||||
| Start Date | 2022-07-01 | ||||||
| Completion Date | 2024-11-01 | ||||||
| Primary Completion Date | 2024-11-01 | ||||||
| Phase | N/A | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 62 |
| Condition | |
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| Intervention |
Intervention Type: Behavioral Intervention Name: Peer Caregiver Navigation (PCN) Description: PCN focuses on the psychosocial needs of FCGs and utilizes trained, non-professional, former cancer FCGs to serve as "peer caregiver navigators". Arm Group Label: Peer Caregiver Navigation |
| Eligibility |
Criteria:
Eligibility Criteria for Family Caregivers: - Must be 18 years of age or older. - Must serve as the unpaid family caregiver of an adult patient with a recent diagnosis (< 3 months) of an advanced solid tumor with overt metastases with a prognosis of ≤ 1 year. As is common in caregiving research, we will define "family caregiver" as anyone substantially involved in a patient's care on an unpaid basis; a legal or biological relationship will not be required. - Able to understand and willing to provide verbal consent. Eligibility Criteria for Key Stakeholders: - Must be 18 years of age or older. - Employed by/affiliated with Siteman Cancer Center OR a former peer caregiver navigator. - Must consent to participate. Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
| Overall Official |
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| Overall Contact | Contact information is only displayed when the study is recruiting subjects. | ||||||
| Location |
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| Location Countries |
United States |
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| Verification Date |
2022-07-01 |
| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 3 |
| Arm Group |
Label: Usual Care Type: No Intervention Description: Usual care consists of reliance on the FCG's social support network and peer support groups facilitated primarily by healthcare providers. Label: Peer Caregiver Navigation Type: Experimental Description: Peer Caregiver Navigation (PCN) is a 1:1 peer mentoring service designed to help FCGs navigate and ultimately mitigate the distress of caregiving. Over an approximately 10-week period, FCGs randomized to the intervention group will receive 5 emotional support and coping skills coaching sessions from a navigator trained in evidence-based techniques to improve coping, including: motivational interviewing, psychoeducation, cognitive restructuring, emotion regulation and awareness, behavioral activation/activity planning, and mindfulness-based strategies. The intervention will be adaptive, with the navigator and study team working together to provide targeted interventions specific to the FCG's needs. The intervention will be delivered via telephone, videoconferencing technology, or in-person at the FCG's home. Label: Key Stakeholders Type: No Intervention Description: Key Stakeholders will be asked to describe the strengths and weaknesses of the supportive services their organization/clinic presently offers FCGs, offer their perspective about the reasons why similar programs have been discontinued, and identify barriers and facilitators for implementing a program like PCN into outpatient oncology settings that are in service to both rural and urban FCG populations. |
| Patient Data | No |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Family Caregivers (FCGs) will be randomized in a 1:1 basis to usual care or intervention. In addition, key stakeholders including former family caregivers of cancer patients, clinicians, and clinic administrators will participate in one interview. Primary Purpose: Other Masking: None (Open Label) |
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