Survivorship
Conditions
Keywords
Dialectical Behavioral Therapy, Psychosocial Oncology, Lung Cancer, Psychological Distress
Brief summary
In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an 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). The investigators will explore emotion regulation as a potential mechanism of change.
Detailed description
Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 9-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, \>80% adherence to assigned interventions and assessments, \<25% attrition) and acceptability (\>3/5 satisfaction study procedures, \>3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in emotional distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 9-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.
Interventions
BEHAVIORALLiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer
Sponsors
Medical University of South Carolina
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * AJCC Stage IV non-small cell lung cancer * Receiving treatment with non-curative intent * English proficiency * Able to provide informed consent * National Comprehensive Cancer Network distress screening score ≥ 3/10
Exclusion criteria
* Cognitive impairment * Untreated serious mental illness * Expected survival \< 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Anxiety Short Form (8a) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (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 anxiety symptomology. |
| PROMIS Depression Short Form (8a) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intolerance of Uncertainty Scale - Short Form (IUS-12) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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 3 month follow-up (week 24) | 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 3 month follow-up (week 24) | 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. |
| PROMIS Self-Efficacy for Managing Symptoms Short Form (8a) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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. |
| PROMIS Self-Efficacy for Managing Emotions (8a) Short Form | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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. |
| NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | The NCI-PRO-CTCAE will be used to assess patient-reported symptom frequency, severity, and interference related to lung cancer and its treatment. Items are rated on a 5-point Likert scale, with higher scores indicating greater symptom burden. |
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | The FACT-L will be used to assess patient-reported quality of life across physical, social/family, emotional, and functional domains, as well as lung 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. |
| DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS) | Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24) | 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. |
Contacts
CONTACTBenjamin Axelrod
PRINCIPAL_INVESTIGATORKelly Hyland, PhD
Medical University of South Carolina
Outcome results
None listed