Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted-telerehabilitation
BehavioralParticipant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/stept count; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)
Waitlist
Behavioral8-week waiting period prior to targeted telerehabilitation
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Targeted telerehabilitationExperimental treatment 1 intervention
Group B: WaitlistActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Health-related quality of life (HRQL)
Global health-related quality of life (EORTC QLQ C30 global/QoL subscale)
Time frame
Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)Secondary outcomes
1
Dysnea and physical activity (participant-chosen)
University of California Shortness of Breath Questionnaire (UCSD SOBQ) and Fitbit stepcount
Time frame
Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)2
Cancer-related function (participant chosen)
PROMIS-SF Cancer Function 3D Profile (fatigue, role, and social function)
Time frame
Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)3
Fear of Cancer Recurrence and Cancer-related Anxiety (participant chosen)
Fear of Cancer Recurrence (FCR) and PROMIS-SF Anxiety 8a
Time frame
Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov