LiveWell mBC Pilot RCT

LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Survivorship
• Intervention / Treatment: Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program

Detailed Description

Participants will be randomized 2:1 to receive LiveWell mBC, an adapted DBT Skills Training intervention delivered to small groups of women with mBC via telehealth, or usual care. LiveWell mBC involves orientation + an 8-session skills training protocol of mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness.

Participants will complete self-report measures at baseline, mid-intervention (Week 5), post-intervention (Week 11) and 1 month post-intervention (Week 15). It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (>70% overall retention rate, >70% LiveWell mBC completion rate); 2) RCT methods will demonstrated evidence of acceptability (>50% enrollment rate, >80% participant satisfaction); and 3) LiveWell participants will demonstrate reductions in distress (primary outcome) compared to Usual Care at 11-week follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn Moody; Phone Number: 843-792-9698; Email: moodykat@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Will receive a handout with general support resources available at Hollings Cancer Center.
Experimental: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program; 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; LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerance of Uncertainty Scale - Short Form (IUS-12)	The 12-item Intolerance of Uncertainty Scale (IUS) Short Form will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.	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	The 5-item Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale will be used to assess patient-reported acceptance, inner peace, and tranquility in the context of cancer. The subscale has a score range of 5-20, where a higher score indicates greater peaceful acceptance of illness.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Positive Affect Short Form (15a)	The PROMIS Positive Affect Short Form 15a will be used to assess patient-reported positive emotions and well-being over the past 7 days. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater positive affect.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Difficulty in Regulating Emotions Scale (DERS-18)	The DERS-18 will be used to assess emotion dysregulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.	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)	The 10-item Cognitive and Affective Mindfulness Scale-Revised will be used to assess patient-reported mindfulness qualities, including present-moment awareness, acceptance, and attention. The CAMS-R has a score range of 10-40, where a higher score indicates greater mindfulness.	Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)	The DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) will be used to assess patient-reported frequency of skill use to manage difficult situations. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)	The NCI-PRO-CTCAE will be used to assess patient-reported symptom frequency, severity, and interference related to breast cancer and its treatment. Items are rated on a 5-point Likert scale, with higher scores indicating greater symptom burden.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Emotions Short Form (8a)	The PROMIS Self-Efficacy for Managing Emotions 8-item Short Form will be used to assess patient-reported confidence in managing negative emotions and emotional distress related to chronic illness. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing emotions.	Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)	The PROMIS Self-Efficacy for Managing Symptoms 8-item Short Form will be used to assess patient-reported confidence in managing symptoms and limiting their interference with daily life. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing symptoms.	Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
Functional Assessment of Cancer Therapy - Breast (FACT-B)	The FACT-B will be used to assess patient-reported quality of life across physical, social/family, emotional, and functional domains, as well as breast cancer-specific concerns. Items are rated on a 5-point Likert scale (0 = Not at all to 4 = Very much) and summed to form subscale and total scores. Higher subscale and total scores indicate better quality of life.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Emotional Support	The PROMIS Emotional Support (4a) Short Form will assess social support. The PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater access to social support networks.	Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Group Therapy Experience Scale	The Group Therapy Experience Scale will measure perceived cohesion, self-disclosure, and satisfaction with group therapy. The 16 item scale uses a Likert scale with responses ranging from 1(strongly disagree) to 5(strongly agree). Higher scores indicate higher satisfaction with group therapy.	Post-intervention (week 11)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Kelly Hyland, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer; Distress; Dialectical Behavioral Therapy; Psychosocial Oncology
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00149650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No