LiveWell mBC Pilot RCT

NCT07539649 | Not Yet Recruiting

• 1 other identifier: Pro00149650
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Dialectical Behavioral Therapy; Metastatic Breast Cancer; Distress; Psychosocial Oncology

Outcome Measures

Primary Outcomes (2)

• PROMIS Depression Short Form (8a)

  Depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater depressive symptomology.

  Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)

• PROMIS Anxiety Short Form (7a)

  Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater anxiety symptomology.

  Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)

Secondary Outcomes (12)

• Intolerance of Uncertainty Scale - Short Form (IUS-12)

  Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)

• Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale

  Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)

• PROMIS Positive Affect Short Form (15a)

  Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)

• Difficulty in Regulating Emotions Scale (DERS-18)

  Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)

Study Arms (2)

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

EXPERIMENTAL

Will receive 9 telehealth-delivered small group (6-8 participants) sessions (orientation + 8 session DBT skills training protocol) co-facilitated by two skills trainers. Sessions will be 90 minutes each and delivered approximately weekly. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic breast cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings.

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

Usual Care

NO INTERVENTION

Will receive a handout with general support resources available at Hollings Cancer Center.

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified female are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• identify as female
• be diagnosed with metastatic (AJCC stage IV) breast cancer
• be receiving care for metastatic breast cancer at Hollings Cancer Center
• endorse \>3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist
• be \> 18 years of age
• be able to understand, speak, and read English
• be able to provide informed consent.

You may not qualify if:

• reported or suspected cognitive impairment
• presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
• expected survival \<6 months, as indicated by a hospice referral

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American Cancer Society, Inc.: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kelly Hyland, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Moody

CONTACT

843-792-9698; moodykat@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04