CASA InterventionPhase 1Beyond IDNCT07828288
Beyond Psychological Distress: Implementation of a Dyadic Behavioral Intervention Targeting Neuroendocrine and mRNA Translational Pathways in Late-Stage Breast Cancer
A Phase 1 study testing 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 in people with CASA Intervention and Usual Care, run by Ponce Medical School Foundation, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- CASA Intervention, Usual Care
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Male patients with a confirmed Stage III or IV breast cancer diagnosis.
About this study
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.
Read the 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.
- Conditions
- CASA Intervention, Usual Care
- Being tested
- 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 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
- Keywords
- CANCER, BREAST, ADVANCED CANCER, Psychosocial support
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 advanceBehavioural
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.
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 primarBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CASA InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828288
- Sponsor's protocol ID
- 2605335687
- Acronym
- Beyond ID
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Psychological Distress: Implementation of a Dyadic Behavioral Intervention Targeting Neuroendocrine and mRNA Translational Pathways in Late-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07828288
- Acronym / sponsor ID
- Beyond ID / 2605335687
- Conditions
- CASA Intervention, Usual Care
- Keywords
- CANCER, BREAST, ADVANCED CANCER, Psychosocial support
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASA: The Caregivers-Patients Support to Cope with Advanced Cancer (CASA) is a five-session | Experimental | 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 advanceThe 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. |
| Control | Active comparator | 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 primarControl 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Male patients with a confirmed Stage III or IV breast cancer diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 advanceThe 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. | Behavioural | 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 primarControl 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. | Behavioural | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for CASA Intervention
Recruiting
Strong Families Start at Home/Familias Fuertes Comienzan en Casa
Metabolic Syndrome, Protection Against, Diet, Healthy
Enrolling by invitation
Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention
Advanced Cancer, Caregivers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 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 in people with CASA Intervention and Usual Care, run by Ponce Medical School Foundation, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire depression scale (PHQ-8) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.