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Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention

Study acronym: CASA
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Enrollment increased: 30 → 62 participantsv4 Show 4 more changesShow less
    • Start date changed from estimate of Jul 1, 2027 to Jan 1, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 380 words
    • Collaborators shortened, about 9 words
  3. Primary endpoint(s) modified
    • Secondary endpoints revised (2)
    v3
  4. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 5 more changesShow less
    • Primary and study completion dates: Feb 28, 2026 to Jul 30, 2027
    • Start date: Mar 12, 2025 to Jul 1, 2027
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 2 words
    • Study title shortened, about 3 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 interventions in the proposed catchment area.
Trial Details
NCT Number NCT06883058
Lead Sponsor Ponce Medical School Foundation, Inc.
Conditions
(from sponsor)		 Advanced Cancer, Caregivers, Patients, Stage III Cancer, Stage IV Cancer
Related terms Neoplasms
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov