Beyond Psychological Distress: Implementation of a Dyadic Behavioral Intervention Targeting Neuroendocrine and mRNA Translational Pathways in Late-Stage Breast Cancer (Beyond ID)
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.
Study Overview
Status
Conditions
Intervention / Treatment
- 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
- 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
Detailed Description
Phase 1: Recruitment and Screening. The study team will use the PRI/PHSU network and activities (e.g. Community engagement workshops) to market the study invitation with providers and community stakeholders. In addition, project flyers will be posted in the main community center, oncology clinics, and on social media outlets for support group participation. Similar recruiting methods have been successful in previous qualitative studies. While the team does not anticipate difficulties obtaining the target sample, if necessary, face- to-face visits to oncology clinics, provider offices, support groups will be conducted. Screening and Engagement. Lists of potential participants will be created during recruitment activities and a follow-up call will be made to verify participation eligibility. Assessments. The project manager will coordinate all data collection activities.
Phase 2: The team will use the PRI/PHSU network and activities to share study flyers with community stakeholders and clinical psychology doctoral students. The team does not expect recruitment challenges as these approaches have resulted in successful recruitment in the past. If necessary, the team will use a back-up recruitment strategy by giving workshops on the intervention at PRI/PHSU and in the community. Screening and Engagement. Lists of potential participants will be created during recruitment activities, and a follow-up call will be made to verify participation eligibility.
Phase 3: All recruiters (trained community members) will be members of communities in the southern area of Puerto Rico to facilitate trust with participants. The team will post flyers of the intervention in the main community center, oncology clinic, on social media, at public announcements at major church events, and at recruitment tables during festivities organized by the community for support groups. We have used these approaches successfully to recruit patients and caregivers for previous studies, including recruitment of a similar population of 62 patients and caregivers in one and a half year. If necessary, the team will use a back-up recruitment strategy by sampling from additional nearby clinics and community organizations serving cancer patients and caregivers. Lists of potential participants will be created during recruitment activities, and a follow-up call will be made to verify participation eligibility. Before conducting screening procedures, consent will be obtained to allow for phone call, which will establish eligibility. Screening criteria will be implemented via phone service. Community members (CM) will administer the Distress Thermometer to patients. Once inclusion/exclusion criteria are verified, CMs will explain study procedures, including singing consent forms, to participants and design a plan to address any barriers to participation.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Male patients with a confirmed Stage III or IV breast cancer diagnosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CASA: The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session
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.
|
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.
|
|
Active Comparator: Control
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire depression scale (PHQ-8)
Time Frame: 5 minutes
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2605335687
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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