Evaluating the Feasibility and Preliminary Effects of BE+

NCT07214441 | Enrolling By Invitation

• 1 other identifier: Pro00144866
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This non-randomized, single group study will test a 12-week, behavioral intervention for physical activity and stress management for survivors of non-small cell lung cancer (NSCLC) and a partner (family member or friend). The goals of this intervention, Breathe Easier+ (BE+), are to increase overall physical activity and overall fitness and to reduce symptoms (fatigue, breathlessness, sleep, and stress). The aim of this study is to evaluate the enrollment, retention, adherence, participation, and acceptability of the 12-week BE+ among NSCLC survivors and their partners. The study also aims to:

1. 1.Explore preliminary intervention effects of BE+ on increasing physical activity and overall fitness (measured by 7-day Fitbit wear, step-in-place test, chair sit-and-stand, arm curl test, and balance test) from baseline to post-intervention among NSCLC survivors and their partners.
2. 2.Explore preliminary effects of BE+ for improvement in stress response, symptom burden (fatigue, dyspnea), sleep, and HRQL from baseline to post-intervention among NSCLC survivors and their partners.

Conditions

Lung Cancer (Non-Small Cell); Self-management Behavior; Physical Activity; Stress; Quality of Life; Resistance Training

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of the 12-week BE+ (BE with RT) among NSCLC survivors and their partners (dyads).

  Feasibility will be evaluated on: 1. Enrollment (25% of eligible participants), 2. Retention (80% of participants at study completion), 3. Adherence (80% to complete instruments at time points 1-3; Fitbit wear \>5 days each week for 12 weeks), 4. Participation (80% to log physical activity weekly, log breathing exercises weekly, set goals weekly, attend 2 resistance training sessions weekly, participate in weekly phone call, and read daily text messages),

  12 weeks

Secondary Outcomes (6)

• Explore preliminary effects of BE+ on increasing physical activity and overall fitness from baseline to post-intervention among NSCLC survivors and their partners (dyads).

  12 weeks

• Explore preliminary effects of BE+ for reduction in dyspnea from baseline to post-intervention among NSCLC survivors and their partners (dyads).

  12 weeks

• Explore preliminary effects of BE+ for reduction in stress response from baseline to post-intervention among NSCLC survivors and their partners (dyads).

  12 weeks

• Explore preliminary effects of BE+ for improvement in sleep from baseline to post-intervention among NSCLC survivors and their partners (dyads).

  12 weeks

• Explore preliminary effects of BE+ for reduction in fatigue from baseline to post-intervention among NSCLC survivors and their partners (dyads).

  12 weeks

Study Arms (1)

Breathe Easier+

EXPERIMENTAL

Breathe Easier+ includes guided instruction using a digital manual, a walking program, RT training sessions, a weekly telephone coaching call, daily text messages, and assessments at three time points.

Behavioral: Breathe Easier+

Interventions

Breathe Easier+ BEHAVIORAL

Breathe Easier+ includes guided instruction using a digital manual, a walking program, RT training sessions, a weekly telephone coaching call, daily text messages, and assessments at three time points.

Breathe Easier+

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Survivors of NSCLC who have completed definitive treatment within the last 2 years.
• All participants must have a health clearance for physical activity signed by a healthcare provider; have Wi-Fi access; be able to provide informed consent; and be able to speak and read English.

You may not qualify if:

• Survivors on current definitive treatment.
• All participants with a history of recurrent falls; a substantial mobility impairment related to chronic disease or injury; and lack of physical activity readiness as determined by a healthcare provider.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

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Related Links

• American Cancer Society. (2025). Cancer facts and figures 2025.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 9, 2025
• Study Start: August 15, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)