Caregivers-Patients Support to Cope With Advanced-Cancer (CASA) Pilot Study.

NCT07639268 | Enrolling By Invitation

• 1 other identifier: 45562
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.

Conditions

Cancer (Advanced Stage); Caregivers; Patients; Stage III Cancer; Stage IV Cancer

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp)

  The Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) 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 at baseline (one to two weeks prior to the intervention) and post-intervention (one to two weeks following completion of the intervention). Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) range from 0 to 48, with higher scores indicating greater spiritual well-being.

  [Time Frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)]

Study Arms (2)

Placebo Comparator: Usual Care Usual care will be provided to participants in the control group. The

PLACEBO COMPARATOR

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.

Behavioral: Placebo Comparator: Usual Care

Experimental: CASA The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be d

EXPERIMENTAL

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: Experimental: CASA

Interventions

Experimental: CASA BEHAVIORAL

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.

Experimental: CASA The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be d

Placebo Comparator: Usual Care BEHAVIORAL

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

Placebo Comparator: Usual Care Usual care will be provided to participants in the control group. The

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• too ill to participate, all as reported by the participant and/or determined by the investigator's judgment

Sponsors & Collaborators

• Ponce Medical School Foundation, Inc.: lead

Study Sites (1)

Ponce Health Science University

Ponce, PR, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Normarie Torres Blasco

  Ponce Health Science University

  PRINCIPAL INVESTIGATOR

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: June 5, 2026
• First Posted: June 10, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

PR (1)