Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score \>=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
Duke Cancer Institute
Durham, North Carolina, United States
Feasibility as Measured by Study Accrual
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Time frame: Post-intervention (approximately 8 weeks)
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
Adherence will be shown by at least 80% of intervention sessions completed.
Time frame: Post-intervention (approximately 8 weeks)
Feasibility as Measured by Number of Participants Lost From the Study Over Time
Treatment feasibility will be shown by no more than 25% study attrition.
Time frame: Post-intervention (approximately 8 weeks)
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.
Time frame: Post-intervention (approximately 8 weeks)
Psychological Distress as Measured by the PROMIS Depression Short Form Scales
Distress 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 distress.
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
Distress 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 distress.
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI). The FSI has a score range of 0 to 10, where a higher score indicates more fatigue.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Dyspnea
Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS). The MMRCDS has a score range of 0 to 4, where a higher score indicates worse dyspnea.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
The Intolerance of Uncertainty Short Form (IUS) 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.
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Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the 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, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)