Psycho-oncology · 2025
LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer.
Клиническое исследованиеСтатьяПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Hyland Kelly A, Neacsiu Andrada D, Fisher Hannah M, Cowperthwait Colleen M, Chou Natalie, Stinchcombe Thomas E, Oeffinger Kevin C, Porter Laura S, Dorfman Caroline S, Keefe Francis J, Somers Tamara J
Аннотация
BACKGROUND: People living longer with metastatic non-small cell lung cancer (mNSCLC) experience heightened psychological distress and decrements in quality of life. Therefore, we developed LiveWell, an 8-session adapted dialectical behavioral therapy skills training (DBT-ST) protocol delivered one-on-one via telehealth to reduce psychological distress.
AIM: To conduct a single-arm pilot trial examining the feasibility and acceptability of LiveWell and explore change in outcome variables.
METHODS: Patients receiving systemic therapy for mNSCLC with at least mild distress participated. Outcomes were feasibility (accrual N = 30 in 18 months, > 80% sessions attended, < 25% attrition) and acceptability (> 80% participant satisfaction). Distress (depression and anxiety symptoms; primary outcomes), intolerance of uncertainty, emotion regulation, illness acceptance, symptoms (e.g., fatigue, dyspnea, pain), skill use, and quality of life (secondary outcomes) were assessed at baseline, post-intervention (primary endpoint), and 1-month post-intervention and examined with paired sample t-tests.
RESULTS: Thirty participants (Mage = 63 years, 77% female) consented and completed the baseline assessment. LiveWell met feasibility (accrual N = 30 in 8 months, 93% sessions attended, 87% retention at post-intervention) and acceptability (96% satisfaction) benchmarks. Participants demonstrated reductions in distress (depression d = 0.35, anxiety d = 0.22) from baseline to post-treatment. Intolerance of uncertainty (d = 0.71), emotion regulation (d = 0.49), and illness acceptance (d = 0.45) improved. Fatigue and pain remained stable or improved (d's 0.07-0.38). Skill use increased (d = 0.65) and quality of life improved (d = 0.21). Improvements were maintained or enhanced at 1-month follow-up.
CONCLUSIONS: LiveWell was feasible and acceptable, and participants demonstrated promising improvement in primary and secondary outcomes. Findings support a larger randomized efficacy trial.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04973436.
AIM: To conduct a single-arm pilot trial examining the feasibility and acceptability of LiveWell and explore change in outcome variables.
METHODS: Patients receiving systemic therapy for mNSCLC with at least mild distress participated. Outcomes were feasibility (accrual N = 30 in 18 months, > 80% sessions attended, < 25% attrition) and acceptability (> 80% participant satisfaction). Distress (depression and anxiety symptoms; primary outcomes), intolerance of uncertainty, emotion regulation, illness acceptance, symptoms (e.g., fatigue, dyspnea, pain), skill use, and quality of life (secondary outcomes) were assessed at baseline, post-intervention (primary endpoint), and 1-month post-intervention and examined with paired sample t-tests.
RESULTS: Thirty participants (Mage = 63 years, 77% female) consented and completed the baseline assessment. LiveWell met feasibility (accrual N = 30 in 8 months, 93% sessions attended, 87% retention at post-intervention) and acceptability (96% satisfaction) benchmarks. Participants demonstrated reductions in distress (depression d = 0.35, anxiety d = 0.22) from baseline to post-treatment. Intolerance of uncertainty (d = 0.71), emotion regulation (d = 0.49), and illness acceptance (d = 0.45) improved. Fatigue and pain remained stable or improved (d's 0.07-0.38). Skill use increased (d = 0.65) and quality of life improved (d = 0.21). Improvements were maintained or enhanced at 1-month follow-up.
CONCLUSIONS: LiveWell was feasible and acceptable, and participants demonstrated promising improvement in primary and secondary outcomes. Findings support a larger randomized efficacy trial.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04973436.