Evaluating the Feasibility and Preliminary Effects of BE+
- Conditions
- Lung Cancer (Non-Small Cell)Self-management BehaviorPhysical ActivityStressQuality of LifeResistance Training
- Registration Number
- NCT07214441
- Lead Sponsor
- University of South Carolina
- 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. 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).
- Detailed Description
Lung cancer is the second-most diagnosed malignancy, accounting for more annual deaths than breast, prostate, and colorectal cancers combined. Approximately 80% of lung cancer diagnoses are non-small-cell lung cancer (NSCLC), 42% will present with localized disease and 58% will present with advanced disease. Scientific advances have led to improved 5-year survival rates. These advances are projected to improve, meaning that survivors of NSCLC will live longer. However, the extent of thoracic resection, radiation, chemotherapy, and immunotherapy treatment; common comorbid conditions like COPD (chronic obstructive pulmonary disease); and health behaviors exacerbate physical and emotional health burdens. Research has yet to address the management of physical deconditioning and unresolved symptoms (e.g., dyspnea, fatigue) in long-term survivors of lung cancer, both of which negatively impact health-related quality of life (HRQL). Self-management interventions that target lifestyle behaviors such as physical activity and stress reduction have demonstrated meaningful benefit in managing symptom burden. Additionally, scientific consensus supports the use of resistance training (RT) to mitigate functional decline from physical deconditioning by increasing muscular strength and endurance. However, frequently NSCLC survivors are sedentary or insufficiently active.
Lifestyle behaviors tend to cluster in families and social networks; thus, family members and friends of survivors are also at risk of poor health. An emerging consensus corroborates the inclusion of family and friends ("partners") of cancer survivors in self-management interventions. In this proposal, a partner is anyone the survivor considers a supportive person. Partners are critical sources of all types of social support across the cancer continuum. Importantly, partners must cope with their own concerns, including uncertainty surrounding the survivor's illness, fear of losing their partner, and the impact of their own health behaviors. Together, survivors and their partners may benefit significantly from a dyad-based lifestyle behavior intervention that supports physical and emotional health.
This research team has conducted extensive formative and preliminary research to develop a dyad-based intervention for NSCLC survivors and their partners. Early on, participants clearly indicated a preference for home-based, family- and safety-oriented interventions. Most recently, participants demonstrated the feasibility and preliminary effectiveness of a 12-week, dyad-based, telephone-delivered, self-management intervention known as Breathe Easier (BE), featuring mindfulness-based breathing exercises, meditation, and a walking program for dyads (N = 40; 20 dyads). Another study involved testing an RT program tailored to survivors only (n = 14). Feasibility and acceptability were strong and indicated positive improvements involving symptom burden and physical functioning.
Recognizing that evidence supports a multimodal approach, our research team aims to expand the BE intervention by integrating home-based RT via digital technology. The revised intervention will be known as BE+ and will include stage IV survivors to better understand the feasibility of this subgroup.
Theoretical Approach: The ORBIT model, which is a systematic framework for developing behavioral interventions, was used to develop a chain of evidence for the BE+ intervention program. BE+ is also built on the individual and family self-management theory (IFSMT), which proposes that successful change in health behavior self-management after a diagnosis of lung cancer requires active involvement by the survivor coupled with partner support. IFSMT encompasses three broad dimensions (context, process, outcomes) and promotes self-regulation, self-efficacy, and social support. The context dimension may impact individual and partner engagement in the self-management process and, therefore, the outcomes. Within the process dimension, self-regulation of the self-management of behaviors requires active involvement. Social support enhances the capacity to change and influences collaboration among dyads. The program components of BE+ enhance these three factors-leading to improved health behaviors. The behaviors of individuals in close, personal relationships are interdependent, and the actions of one person continuously affect the other's actions.
Design: A 12-week, non-randomized, one group pre-post feasibility study piloted among NSCLC survivors and their partners.
A purposive sample of 10 dyads (N = 20 participants) will be recruited from two cancer treatment centers in South Carolina. A partner, defined as a relative or close friend (i.e., spouse, sibling, adult child, neighbor), will be required for enrollment.
Analysis Plan: A power analysis will not be performed as this feasibility study does not warrant formal hypothesis testing, and all statistical tests will use an α cut point of 0.10 for meaningful preliminary differences. This nontraditional cut point (vs. α = 0.05) is more lenient due to the feasibility study design. Data analysis software will be used to obtain information regarding step count, and sleep SAS 9.4 (Cary, NC) software will be used to calculate means (± SD) and frequencies for demographic data. Normality will be checked using histogram and Q-Q plots combined with skewness and kurtosis statistics. When the outcome is normally distributed, independent t-tests will be performed to assess subset differences between survivors and partners to evaluate preliminary effects. Equal variances will be determined using the Folded F test, and thus the pooled version of the independent t-test will be used to determine preliminary meaningful differences. Then repeated measures ANOVA will be used to compare means among three time points. If normality is violated, the Mann-Whitney U Test will be used to compare outcome differences between survivors and partners, and Friedman's ANOVA by ranks will be used to evaluate the differences among three time points.
Exit interviews will be audio-recorded and professionally transcribed. The lead investigator will review transcripts and audio recordings to confirm accuracy. Thematic analysis will be used to analyze the transcripts following a six-phase approach: (1) become familiar with the data, (2) generate codes, (3) search for themes, (4) review themes, (5) define or name themes, (6) report findings and analysis.64 Transcripts will be iteratively analyzed by the research team to reach a consensus on codes, categories, and themes.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate the feasibility of the 12-week BE+ (BE with RT) among NSCLC survivors and their partners (dyads). 12 weeks 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),
- Secondary Outcome Measures
Name Time Method Explore preliminary effects of BE+ for improvement in sleep from baseline to post-intervention among NSCLC survivors and their partners (dyads). 12 weeks Fitbit Sleep: Objective measure of sleep quantity based on combined body movement and HRV algorithm. Sleep measures captured by Fitbit include total minutes asleep, minutes awake, minutes to fall asleep, minutes awake after sleep, total time in bed, and sleep stages. Sensitivity = .95; specificity = 0.58-0.69.
Pittsburgh Sleep Quality Index (PSQI): 19 items measuring sleep quality, sleep latency, sleep efficiency, sleep duration, sleep disturbances, use of sleep medications, and daytime dysfunction.55 Cronbach's alpha (α) = 0.77-0.83; r = 0.77-0.85.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 Physical activity and overall fitness will be measured:
7-Day Fitbit Step Count: 7-day total steps, measured during activity tracking, including active zone minutes and step counting for 24 hours/day, found to be accurate with an absolute percent error for steps of 1.5-9.6%.
Sit-to-Stand Test: Evaluates how long a person takes to rise from a chair and return to sitting in the chair, 5 times consecutively. Measured in seconds. A reliable and widely accepted measure of physical function. ICC = 0.937.
Step-in-Place Test: 2-minute marching in place, to estimate aerobic endurance; score is the number of times the right knee reaches the target, which has been validated with ICC = 0.90, correlation coefficient (r) = 0.69.
Arm Curl Test: 30 seconds of arm curls holding a weight to measure upper body strength and muscular endurance; ICC = 0.88.
Single Leg Stance: Length of time participant can stand on 1 leg with hands on hips to limit movement of arms; ICC = 0.87-0.97.Explore preliminary effects of BE+ for reduction in dyspnea from baseline to post-intervention among NSCLC survivors and their partners (dyads). 12 weeks mMRC Dyspnea Scale: 1 item correlates with a self-report of breathlessness. Sensitivity (0.21-0.68), specificity (0.91-1.0).
Explore preliminary effects of BE+ for improvement in health-related quality of life (HRQL) from baseline to post-intervention among NSCLC survivors and their partners (dyads). 12 weeks Short Form Health Survey (SF-36): 36 items evaluating HRQL through physical function, social functioning, physical role limitations, emotional role limitations, emotional health, vitality, pain, and general health perception. α = 0.78-0.93.
Explore preliminary effects of BE+ for reduction in stress response from baseline to post-intervention among NSCLC survivors and their partners (dyads). 12 weeks Fitbit Heart Rate Variability (HRV): Measure of the fluctuation of the length of heartbeat intervals, representing the ability of the heart to respond to varying physiological stimuli, signifying stress response. ICC = 0.6
Explore preliminary effects of BE+ for reduction in fatigue from baseline to post-intervention among NSCLC survivors and their partners (dyads). 12 weeks FACIT Fatigue Scale v.4: 13 items measuring fatigue during usual activity over the past 7 days. α = 0.96; ICC = 0.95.
Trial Locations
- Locations (1)
University of South Carolina
🇺🇸Columbia, South Carolina, United States
University of South Carolina🇺🇸Columbia, South Carolina, United States