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

Not Applicable

Not yet recruiting

• Conditions: Advanced Cancer; Caregivers; Patients; Stage III Cancer; Stage IV Cancer

• Registration Number: NCT06883058
• Lead Sponsor: Ponce Medical School Foundation, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-12
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
• Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria

• (1) diagnosed with a major disabling medical or psychiatric condition, (2) unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FACIT-Sp	5 minutes	is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Cancer patients, psychotherapists, and religious/spiritual experts provided input on the development of the items.

Secondary Outcome Measures

Name	Time	Method
PHQ-9	5 minutes	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
GAD-7	5 minutes	The Generalized Anxiety Disorder 7-item (GAD-7) is a easy to perform initial screening tool for generalized anxiety disorder