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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05455216
Other study ID # 202206153
Secondary ID KL2TR002346
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2022
Est. completion date November 2024

Study information

Verified date July 2022
Source Washington University School of Medicine
Contact Jacquelyn J Benson, M.A., Ph.D.
Phone 573-673-2192
Email bensonj@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer Caregiver Navigation (PCN)
PCN focuses on the psychosocial needs of FCGs and utilizes trained, non-professional, former cancer FCGs to serve as "peer caregiver navigators".

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of psychosocial intervention Peer Caregiver Navigation (PCN) The PCN intervention will be deemed feasible relative to recruitment and retention if 23% of eligible family caregivers are enrolled and an overall maximum attrition rate does not exceed 30%. Approximately 2 years and 13 weeks
Secondary Numbers of potential barriers identified while implementing Peer Caregiver Navigation (PCN) The number and types of potential barriers will be determined by collecting and analyzing the qualitative data from this study. Approximately 2 years and 13 weeks
Secondary Number of potential facilitators identified while implementing Peer Caregiver Navigation (PCN) The number and types of potential facilitators will be determined by collecting and analyzing the qualitative data from this study. Approximately 2 years and 13 weeks
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