Evaluating the Feasibility and Preliminary Effects of BE+

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT07214441
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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. 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. 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. Participants will receive education, social support, coaching, a guided walking program, supervised resistance training (RT), and meditations delivered via digital technology (tablet, smartphone, and Fitbit).

Key Dates

Start date
Aug 15, 2025
Status verified
Oct 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Breathe Easier+
    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.

Primary Outcome Measure

Evaluate the feasibility of the 12-week BE+ (BE with RT) among NSCLC survivors and their partners (dyads). [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208-

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By research site
University of South Carolina· Columbia, SC

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