NCT06883058

Implementation of the Caregivers-Patients Support Coping with Advanced-Cancer (CASA) Intervention.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ponce Medical School Foundation, Inc. · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

This pre-pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.

Conditions

• Advanced Cancer
• Caregivers
• Patients
• Stage III Cancer
• Stage IV Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Caregivers-patients support intervention for advanced cancer (CASA)	The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.
BEHAVIORAL	Placebo	Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.

Timeline

• Start date: 2025-03-12
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-03-19
• Last updated: 2025-03-19