跳至主要内容
临床试验/NCT05179408
NCT05179408招募中不适用

Telerehabilitation for Veteran Lung Cancer Survivors Following Curative Intent Therapy

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Health-related quality of life (HRQL)

研究概览

简要总结

Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans. Substantial advances have been made in early detection through screening and treatment. The longevity of Veterans following lung cancer diagnosis and treatment has increased. Following treatment however, many Veterans experience increased symptom burden, particularly in shortness of breath, fatigue, and fear/anxiety about lung cancer, and impairments in physical and psychosocial functioning. Rehabilitation services are needed to address these survivorship challenges. This study will evaluate multi-targeted telerehabilitation with Veterans following lung cancer treatment, with goals to reduce symptom burden, improve physical and psychosocial function, and enhance health-related quality of life. This research will also develop the career of a physician researcher to acquire expertise in rehabilitation for many Veteran survivors of lung and other cancers.

详细描述

Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans - over 8,200 incident cases are diagnosed each year. Approximately 50% of lung cancers are diagnosed at stage I-III and therefore eligible for curative intent therapy. Survival rates among Veterans with early stage lung cancer have increased along with advances in surgical and radiation techniques. Following curative intent therapy, many Veterans experience physical function loss and increased symptom burden, particularly in dyspnea, fatigue, and fear/anxiety. Approaches are needed to improve their physical and psychosocial function and health-related quality of life (HRQL). We hypothesize that multi-targeted telerehabilitation could mitigate these HRQL impairments. Therefore, we will conduct a pilot randomized trial to examine the (a) feasibility, (b) acceptability, (c) safety, and (d) explore the effects of multi-targeted telerehabilitation with these patients. Participants (N=30-40) will be randomized (3:1) to receive 8 weeks of participant-chosen targeted telerehabilitation (experimental arm) or waitlist condition (control arm). Feasibility will be assessed by enrollment, adherence, retention and exploratory effects by linear mixed effects models comparing changes in patient-centered outcomes from baseline to end-of-intervention between groups: dyspnea, daily step count, fatigue, role/social function, fear/anxiety, and HRQL. This project will provide pilot data and training for an early career physician investigator to establish independence, with a goal of a large-scale, preference-informed randomized trial of targeted and patient-centered telerehabilitation, to improve the physical and psychosocial function, independence, and HRQL of Veteran lung cancer survivors following curative intent therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will be blinded to participant allocation group.

入排标准

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

入选标准

  • •Adult Veterans with a history of stage I-III A/B lung cancer, and
  • •Completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months

排除标准

  • •Adult Veterans with any comorbid conditions that preclude participation in exercise and telerehabilitation:
  • •Orthopedic conditions (e.g., bilateral below-knee amputation), or
  • •Severe cardiopulmonary disease (e.g., unstable arrhythmias including ventricular tachycardia, heart failure with systolic ejection fraction < 25%, chronic hypoxemia needing > 5 L/min oxygen supplementation at rest), or
  • •Inability to follow directions or provide informed consent (e.g., moderate to severe dementia), or
  • •Enrolled in hospice, or
  • •With an estimated life expectancy of < 6 months

研究组 & 干预措施

Targeted telerehabilitation

Experimental

Participant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/endurance; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)

干预措施: Targeted-telerehabilitation (Behavioral)

Waitlist

Active Comparator

8-week waiting period prior to participating in targeted telerehabilitation

干预措施: Waitlist (Behavioral)

结局指标

主要结局

Health-related quality of life (HRQL)

时间窗: Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)

Global health-related quality of life (EORTC QLQ C30 global/QoL subscale)

次要结局

  • Dysnea and physical activity (participant-chosen)(Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks))
  • Cancer-related function (participant chosen)(Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks))
  • Fear of Cancer Recurrence and Cancer-related Anxiety (participant chosen)(Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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