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NCT Number: NCT07539649

LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. PROMIS Depression Short Form (8a)

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

    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.

  2. PROMIS Anxiety Short Form (7a)

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

    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.

Secondary outcomes

  1. Intolerance of Uncertainty Scale - Short Form (IUS-12)

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

    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.

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

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

    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.

  3. PROMIS Positive Affect Short Form (15a)

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

    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.

  4. Difficulty in Regulating Emotions Scale (DERS-18)

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

    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.

  5. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

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

    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.

  6. DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)

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

    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.

  7. NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)

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

    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.

  8. PROMIS Self-Efficacy for Managing Emotions Short Form (8a)

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

    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.

  9. PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)

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

    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.

  10. Functional Assessment of Cancer Therapy - Breast (FACT-B)

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

    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.

  11. PROMIS Emotional Support

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

    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.

  12. Group Therapy Experience Scale

    Time frame: Post-intervention (week 11)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Axelrod

CONTACT

[email protected]

843-876-2645

Kathryn Moody

CONTACT

[email protected]

843-792-9698

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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