跳至主要内容
临床试验/NCT07214441
NCT07214441Enrolling By Invitation不适用

Evaluating the Feasibility and Preliminary Effects of a Remotely Delivered Dyad-Based Intervention Incorporating Resistance Training to Improve Fitness in Individuals With Non-Small-Cell Lung Cancer and in Their Partners

University of South Carolina1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Evaluate the feasibility of the 12-week BE+ (BE with RT) among NSCLC survivors and their partners (dyads).

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Breathe Easier+ (Behavioral)

结局指标

主要结局

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

时间窗: 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),

次要结局

  • 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+ 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 improvement in health-related quality of life (HRQL) 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 reduction in fatigue from baseline to post-intervention among NSCLC survivors and their partners (dyads).(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda Dyer

Assistant Professor

University of South Carolina

研究点 (1)

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