Study Protocol for the Trial: A Pilot RCT of a Dyad-Based, Multiple-Behavior Intervention for Improving Physical and Emotional Health in Survivors Facing Lung Cancer

Overview

Journal Integr Cancer Ther

Publisher Sage Publications

Specialties Oncology
Pharmacology

Date 2023 Nov 27

PMID 38009546

Authors

Karen Kane McDonnell

Jeannette O Andrews

Chih-Hsiang Yang

Brandi R Newsome

Ella Weinkle

Jean Elizabeth Davis

Shira Dunsiger

Affiliations

Soon will be listed here.

Abstract

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 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. (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: 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.

Citing Articles

Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial.

Haun J, Fowler C, Venkatachalam H, Alman A, Ballistrea L, Schneider T J Med Internet Res. 2024; 26:e57322.

PMID: 39422992 PMC: 11530734. DOI: 10.2196/57322.

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