Beyond Psychological Distress: Implementation of a Dyadic Behavioral Intervention Targeting Neuroendocrine and mRNA Translational Pathways in Late-Stage Breast Cancer

NCT07828288 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2605335687
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

Specific Aim 1: Determine the effect of CASA on psychological distress (primary outcome) and on neuroendocrine, inflammatory, and translational control measures (secondary and exploratory outcomes) in LSBC-PR patients and caregivers. We will conduct a two-arm randomized controlled trial of 70 patient caregiver dyads (35 per arm; N=140 individuals) comparing CASA to usual care, with assessments at baseline (T1) and post-intervention (T2, 5 to 10 weeks). This sample provides 80% power (a=0.05, two-tailed) to detect d=0.80 on the primary outcome, consistent with ORBIT Phase 3 signal confirmation. Psychological distress (Distress Thermometer) is the primary outcome and depressive symptoms (PHQ-8) the secondary psychosocial outcome; patients are the primary analytic unit, with caregivers analyzed in parallel. Plasma cortisol is the key secondary biological outcome; inflammatory cytokines (IL-6, TNF-a, IL-1B, IFN-v, IFN-a, IP-10, CRP) are secondary biological outcomes tested with Benjamin Hochberg FDR control; polysome profiling of PBMCs (with Dr. Dharmawardhane, UPR-MSC) is exploratory. Outcomes are tested hierarchically to control family-wise error. Recruitment, intervention delivery, and biospecimen collection will be conducted at the Puerto Rico Biobank (PRBB) under PMSF-PRI IRB oversight, leveraging Alliance partner collaboration (UPR-MSC and PMSF-PRI). Expected Outcome: CASA will produce greater reductions in psychological distress than usual care, with signals in cortisol and inflammatory cytokines that inform a fully powered R01 to confirm stress-biology mechanisms in LSBC-PR dyads. Specific Aim 2: Develop and validate a multilevel implementation strategy for CASA informed by implementation science determinants and stakeholder co-design. Using mixed methods, Consolidated Framework for Implementation Research (CFIR) guided semi-structured interviews (n=20) with oncology and clinic-based stakeholders will be supplemented by validated measures of acceptability, feasibility, and appropriateness. Determinants will be mapped to Expert Recommendations for Implementing Change (ERIC) strategies; co-design sessions will produce a context-specific implementation blueprint. Expected Outcome: A stakeholder-validated implementation strategy that identifies key determinants of CASA uptake and provides an actionable roadmap for scalable delivery across Puerto Rican oncology settings.

Conditions

CASA Intervention; Usual Care

Keywords

CANCER, BREAST, ADVANCED CANCER, Psychosocial support

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire depression scale (PHQ-8)

  The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies.

  5 minutes

Study Arms (2)

CASA: The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session

EXPERIMENTAL

The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session, manualized, meaning-centered psychotherapy developed for Puerto Rican patients and caregivers coping with advanced cancer, with demonstrated preliminary efficacy in reducing psychological distress and improving quality of life.

Behavioral: The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session, manualized, meaning-centered psychotherapy developed for Puerto Rican patients and caregivers coping with advance

Control

ACTIVE COMPARATOR

Control Condition. Includes CBT as the primary treatment approach for cancer patients and it is considered the usual care approach in these clinics, as well as one of the primary lines of treatment for clinical depression and anxiety, in recent ASCO guidelines. Further, multiple reviews/ metanalyses have supported its effectiveness in cancer patients.

Behavioral: Control Condition. Includes CBT as the primary treatment approach for cancer patients and it is considered the usual care approach in these clinics, as well as one of the primar

Interventions

The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session, manualized, meaning-centered psychotherapy developed for Puerto Rican patients and caregivers coping with advance BEHAVIORAL

The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session, manualized, meaning-centered psychotherapy developed for Puerto Rican patients and caregivers coping with advanced cancer, with demonstrated preliminary efficacy in reducing psychological distress and improving quality of life.

CASA: The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session

Control Condition. Includes CBT as the primary treatment approach for cancer patients and it is considered the usual care approach in these clinics, as well as one of the primar BEHAVIORAL

Control Condition. Includes CBT as the primary treatment approach for cancer patients and it is considered the usual care approach in these clinics, as well as one of the primary lines of treatment for clinical depression and anxiety, in recent ASCO guidelines. Further, multiple reviews/ metanalyses have supported its effectiveness in cancer patients.

Control

Eligibility Criteria

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

You may qualify if:

• Only eligible patients with a confirmed Stage III or IV breast cancer diagnosis who score above 4 on the Distress Thermometer and their identified caregivers will be recruited for this study.

You may not qualify if:

• Male patients with a confirmed Stage III or IV breast cancer diagnosis.

Sponsors & Collaborators

• Ponce Medical School Foundation, Inc.: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Not applicable. No additional parties are masked in this clinical trial beyond those described above.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-08