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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
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.
Time frame: 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.
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
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.
Time frame: 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.
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Positive Affect Short Form (15a)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention (week 11)