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LiveWell mBC Pilot RCT, 48 Women, Metastatic Breast Cancer

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Summary

This pilot randomized controlled trial (NCT07539649) will enroll 48 women with metastatic breast cancer experiencing at least mild distress. Participants will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy Skills Training protocol, or Usual Care. Investigators will evaluate feasibility, acceptability, and preliminary efficacy of the intervention for reducing distress as the primary outcome and improving psychological well-being, symptom burden, and quality of life as secondary outcomes.

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What changed

This registry entry documents a pilot randomized controlled trial (NCT07539649) evaluating LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy Skills Training program, in 48 women with metastatic breast cancer experiencing at least mild distress. Participants are randomized to the intervention or Usual Care, with distress reduction as the primary outcome and psychological well-being, symptom burden, and quality of life as secondary outcomes.

This is an informational clinical trial registration; it does not create compliance obligations. Healthcare providers and researchers in psycho-oncology and cancer survivorship may find the study protocol of professional interest.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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LiveWell mBC Pilot RCT

N/A NCT07539649 Kind: NA Apr 20, 2026

Abstract

In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).

Conditions: Survivorship

Interventions: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Mental health intervention research Oncology survivorship care
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Healthcare

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