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Protocol of a randomized trial of "pathways," a hope intervention for people undergoing treatment for advanced lung
Laurie E McLouth1, Courtney Blair2, Brent J Shelton3
1Department of Behavioral Science, Center for Health, Engagement, and Transformation, University of Kentucky, 800 Rose St., Lexington, KY 40536, USA; Markey Cancer Center, University of Kentucky, 750 Rose St., Lexington, KY 40536, USA.
Objective:
Advanced cancer and its treatment can disrupt personal goal pursuits and attainment, which can imperil patient quality of life and increase risk for depression. Hope interventions foster the goal-pursuit skills exemplified by high-hope individuals and, based on a pilot trial, are a promising approach to support these patients. The current Phase II trial (NCT06047301) aims to determine the efficacy of a brief, hope intervention, "Pathways," in improving depression symptoms for people undergoing treatment advanced stage lung cancer with elevated distress.
Methods:
In this two-arm randomized controlled trial, 234 people undergoing treatment for advanced stage lung cancer are randomized to Pathways or enhanced usual care. The Pathways intervention consists of a cancer resource guide and five sessions (150-180 min total) delivered primarily during infusion or by phone by nurse practitioners or social workers. Sessions focus on identifying values, setting goals, building pathways, and agency thinking. Enhanced usual care consists of receiving and reviewing the cancer resource guide with staff. Outcomes are assessed at baseline, mid-intervention, and at 2-, 6-, and 12-weeks post-intervention. The primary outcome is depression symptoms at 2 weeks. Secondary outcomes include measures of anxiety, demoralization, positive affect, meaning and peace, social and role function, and quality of life.
Results:
Recruitment began in November 2023; 94 patients have enrolled as of November 5, 2025.
Conclusion:
If efficacious, Pathways may be a pragmatic point-of-care intervention to address cancer-related goal disruption and ultimately support the mental health and quality of life of patients receiving treatment for advanced lung cancer.