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Study Protocol for the Breathe Easier Trial: A Pilot RCT of a Dyad-Based, Multiple-Behavior Intervention for
Karen Kane McDonnell1, Jeannette O Andrews1, Chih-Hsiang Yang1
1University of South Carolina, Columbia, SC, USA.
Background:
Research targeting survivors of lung cancer has yet to adequately address the management of physical deconditioning and unresolved symptoms (dyspnea, fatigue). The objective of the Breathe Easier trial is to test the feasibility and preliminary effects of a theory-based, multiple-behavior intervention (physical activity, smoking reduction for current smokers, stress management) targeting survivors of localized non-small-cell lung cancer (NSCLC, stages I-III) and their supportive partners.
Methods:
This pilot RCT will enroll 30 dyads (60 participants). Each dyad will consist of one survivor and one partner (defined as a family member or friend) Dyads will be randomized to the Intervention Group (IG) or the Attention Control Group (AC). IG members will receive the 12-week, home-based intervention based on the individual and family self-management theory, which targets improvements in self-efficacy, social support, and self-regulation. Improvement in lifestyle behaviors is a proximal outcome. Improvements in physical and emotional health are distal outcomes. Breathe Easier (IG) includes educational content written in plain language as well as breathing exercises and meditations; SMART goal setting; daily text messaging; and weekly telephone calls with trained staff. The AC program includes relevant National Institutes of Health publications plus weekly telephone chats. Members who currently smoke will also receive an evidence-based smoking cessation resource.
Discussion:
Breathe Easier focuses on changes in multiple behaviors in dyads coping with a diagnosis of NSCLC (stages I-III) with the overall purpose of improving physical and emotional health. Findings will provide additional evidence of the feasibility and preliminary effects of this intervention.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05956782; This trial was registered retrospectively.
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