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

2026년 9월 14일 업데이트: Ponce Medical School Foundation, Inc.

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

114

단계

  • 1단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient Health Questionnaire depression scale (PHQ-8)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 7월 30일

연구 등록 날짜

최초 제출

2026년 9월 14일

QC 기준을 충족하는 최초 제출

2026년 9월 14일

처음 게시됨 (실제)

2026년 9월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2605335687

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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