LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
ConditionSurvivorship
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical University of South Carolina
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
BehavioralLiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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.
Time frame
Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)4
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)Locations
Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov
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