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Can a Five-Session therapy ease distress and calm stress biology in Late-Stage breast cancer?

NCT ID NCT07828288

Symptom relief Sponsor: Ponce Medical School Foundation, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing a five-session meaning-centered psychotherapy called CASA in Puerto Rican patients with Stage III or IV breast cancer and their caregivers. The trial compares CASA with usual care in about 114 people to see whether the therapy reduces psychological distress, the main outcome, and whether it changes stress hormones and inflammatory markers in the blood. A second part of the study asks oncology staff and clinic stakeholders what would make CASA practical to deliver across Puerto Rican cancer settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A five-session meaning-centered psychotherapy program called CASA, delivered to patients with advanced breast cancer and their caregivers together
What this could lead to
If it helps, CASA could become a structured way for oncology clinics to support both patients with advanced breast cancer and the caregivers who look after them. Signals in cortisol and inflammatory markers could also point researchers toward how emotional support affects the body's stress response.
What could go wrong
This is an early-phase trial with about 114 people at one site in Puerto Rico, so the results may not hold in larger or more diverse groups. Distress and stress-hormone changes are hard to measure, and the therapy may work no better than usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Casa intervention Usual care

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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