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

Ponce Medical School Foundation

Status: Not yet enrolling

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

Treatments: Behavioral: Caregivers-patients support intervention for advanced cancer (CASA); Behavioral: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06883058

2411224820

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups, including a placebo group

Usual Care

Placebo Comparator group

Description:

Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.

Treatment:

Behavioral: Placebo

CASA

Experimental group

Description:

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.

Treatment:

Behavioral: Caregivers-patients support intervention for advanced cancer (CASA)