Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer

VA Office of Research and Development

Status: Enrolling

Conditions: Cancer Survivors; Lung Cancer

Treatments: Behavioral: Waitlist; Behavioral: Targeted-telerehabilitation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05179408

RX003661 (Other Grant/Funding Number)

F3661-W

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Targeted telerehabilitation

Experimental group

Description:

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)

Treatment:

Behavioral: Targeted-telerehabilitation

Waitlist

Active Comparator group

Description:

8-week waiting period prior to participating in targeted telerehabilitation

Treatment:

Behavioral: Waitlist