Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention
CASA
1 other identifier
interventional
30
1 country
1
Brief Summary
This 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2027
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedStudy Start
First participant enrolled
July 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
Study Completion
Last participant's last visit for all outcomes
July 30, 2027
April 24, 2026
April 1, 2026
29 days
March 12, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
FACIT-Sp
The FACIT-Sp-12 is a 12-item measure of spiritual well-being designed for individuals with cancer and other chronic illnesses. Item development was informed by input from cancer patients, psychotherapists, and religious/spiritual experts. The measure will be administered before and after the intervention.
5 minutes
Secondary Outcomes (2)
PHQ-9
5 minutes
GAD-7
5 minutes
Study Arms (2)
Usual Care
PLACEBO COMPARATORUsual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
CASA
EXPERIMENTALThe 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.
Interventions
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.
Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- diagnosed with a major disabling medical or psychiatric condition
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ponce Research Institute
Ponce, PR, 00717, Puerto Rico
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 19, 2025
Study Start (Estimated)
July 1, 2027
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04