Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan-Dec:22:15347354231212876.
doi: 10.1177/15347354231212876.

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

Karen Kane McDonnell  1 , Jeannette O Andrews  1 , Chih-Hsiang Yang  1 , Brandi R Newsome  1   2 , Ella Weinkle  1 , Jean Elizabeth Davis  1 , Shira Dunsiger  3
Affiliations

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

Karen Kane McDonnell et al. Integr Cancer Ther. 2023 Jan-Dec.

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 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.

Keywords: RCT; dyads; lung neoplasm; multiple behaviors; symptom self-management.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Similar articles

See all similar articles

Cited by

References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708 - DOI - PubMed
    1. Cox-Martin E, Cox MG, Basen-Engquist K, Bradley C, Blalock JA. Changing multiple health behaviors in cancer survivors: Smoking and exercise. Psychol Health Med. 2020;25(3):331-343. doi:10.1080/13548506.2019.1679849 - DOI - PMC - PubMed
    1. Bluethmann SM, Mariotto AB, Rowland JH. Anticipating the “silver tsunami”: prevalence trajectories and comorbidity burden among older cancer survivors in the United States. Cancer Epidemiol Biomarkers Prev. 2016;25(7):1029-1036. - PMC - PubMed
    1. Lemjabbar-Alaoui H, Hassan OU, Yang YW, Buchanan P. Lung cancer: Biology and treatment options. Biochim Biophys Acta. 2015;1856(2):189-210. doi:10.1016/j.bbcan.2015.08.002 - DOI - PMC - PubMed
    1. Young RP, Hopkins RJ, Christmas T, et al.. COPD prevalence is increased in lung cancer, independent of age, sex, and smoking history. Eur Respir J. 2009;34(2):380-386. doi:10.1183/09031936.00144208 - DOI - PubMed

Publication types

Associated data