Survivorship
Conditions
Keywords
Dialectical Behavioral Therapy, Metastatic Breast Cancer, Distress, Psychosocial Oncology
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).
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.
Interventions
BEHAVIORALLiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
Sponsors
Medical University of South Carolina
American Cancer Society, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Depression Short Form (8a) | 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. |
| PROMIS Anxiety Short Form (7a) | 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
| Measure | Time frame | Description |
|---|---|---|
| Intolerance of Uncertainty Scale - Short Form (IUS-12) | 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. |
| 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) | 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. |
| PROMIS Positive Affect Short Form (15a) | 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. |
| 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) | 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. |
| 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) | 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. |
| DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS) | 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. |
| NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) | 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. |
| PROMIS Self-Efficacy for Managing Emotions Short Form (8a) | 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. |
| PROMIS Self-Efficacy for Managing Symptoms Short Form (8a) | 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. |
| Functional Assessment of Cancer Therapy - Breast (FACT-B) | 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. |
| PROMIS Emotional Support | 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. |
| Group Therapy Experience Scale | 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. |
Contacts
CONTACTKathryn Moody
CONTACTBenjamin Axelrod
PRINCIPAL_INVESTIGATORKelly Hyland, PhD
Medical University of South Carolina
Outcome results
None listed