NCT03464188

An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers

An Upstream Palliative Care Intervention for Rural Family Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The burden placed on advanced cancer family caregivers (FCGs) and the toll on their mental and physical health have never been greater and is particularly pernicious for underserved groups in the Southeastern U.S., including rural-dwellers and African-Americans, for whom interventions have not been specifically developed and tested. The purpose of this K99/R00 is provide the awardee with the knowledge and training necessary to become a leading independent clinical investigator in developing and testing telehealth palliative care interventions for family caregivers (FCGs) of underserved persons with advanced cancer. The research specific aim during the K99 phase was to develop and tailor the content, format and delivery of a telehealth intervention for FCGs of persons with advanced cancer in the rural South. To meet this aim, qualitative semi-structured interviews were conducted with 26 lay healthcare navigators, 20 FCGs, and 18 patients with advanced cancer to elicit feedback on a FCG intervention outline based on published evidence-based interventions. After thematic analysis, major findings included that the intervention should: have topical content that is flexible and based on continuous assessment; include at least some face-to-face contact; cautiously consider internet-based technologies because internet access in rural areas is poor; and potentially have navigators lead the intervention with appropriate oversight and additional training. K99 study findings have been used to adapt and develop a potentially scalable FCG intervention in the Southern U.S. population (Project Cornerstone). The K99 study phase in combination with accomplishing the training objectives has successfully catalyzed the awardee's transition from a Postdoctoral Fellow to a Tenure-Track Assistant Professor at the University of Alabama at Birmingham School of Nursing. The overall goal during the R00 phase will be to conduct a small-scale pilot RCT of Cornerstone with 70 FCGs of rural-dwelling and/or African-American patients with advanced cancer to assess acceptability, feasibility, and potential efficacy. The research specific aims during the R00 phase are to: evaluate the acceptability of Cornerstone and the feasibility of enrolling and retaining 70 participants into a RCT of the FCG intervention for 24 weeks (Aim 1) and evaluate the potential efficacy of Cornerstone in improving caregiver (Aim 2) and care recipient (Aim 3) outcomes compared to usual care (quality of life and distress \[anxiety/depressive symptoms\]). The results will directly support an R-01 application to conduct an efficacy RCT of an early, telehealth PC intervention for Southern FCGs of underserved persons with advanced cancer.

Detailed description

Enrollment goal was increased from 60 to 70 participants due to attrition.

Conditions

• Cancer, Metastatic
• Family Members

Interventions

Type	Name	Description
BEHAVIORAL	Project Cornerstone	Project Cornerstone basic elements are: 1. The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician; 2. 6 base telephone/in-person sessions: Sessions cover specific topics (every 1-2 weeks, 20-60 minutes/session; by phone or in-person), followed by monthly follow-up and additional coaching sessions as needed; 3. Regular caregiver distress thermometer screening and problem support and self-care coaching. 4. Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions. Project Cornerstone begins within 60 days of a care recipient being diagnosed with advanced cancer and ends 1 year after care recipient death.

Timeline

• Start date: 2018-10-20
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2018-03-13
• Last updated: 2021-05-27

Locations

1 site across 1 country: United States