Telerehabilitation Following Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans. Significant advances have been made in screening and treatment of lung cancer. Longevity following lung cancer has increased. After lung cancer treatment however, many Veterans experience losses in functional capacity and increased symptoms. Rehabilitation services are needed to address these health issues. This study will evaluate a telerehabilitation intervention with Veterans after lung cancer treatment, with goals to improve their function and quality of life, and advance knowledge on strategies to better meet the rehabilitation needs of Veteran lung cancer survivors following treatment. It will also develop the career of a physician researcher to acquire expertise in rehabilitation services for many Veteran lung cancer survivors.

Detailed 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. Consequently, approaches are needed to improve their function and quality of life (QoL). The investigators hypothesize that telerehabilitation could mitigate these adverse effects. Therefore, the investigators seek to conduct a pilot randomized study to examine the (a) feasibility, (b) acceptability, and (c) explore the effects of a telerehabilitation intervention with these patients. Participants (N=40) will be randomized (1:1) to receive 12 weeks of telerehabilitation (experimental arm) or assessment only (control arm). Feasibility will be assessed by enrollment, adherence, and retention; acceptability by System Usability Scales; and exploratory effects by linear mixed effects models comparing changes in function, symptom control, and QoL between groups. This project will provide pilot data and training for an early career physician investigator to establish independence, with a goal of a large-scale randomized trial of an optimized telerehabilitation program to improve the physical and psychosocial function, independence, and QoL of Veteran lung cancer survivors following curative intent therapy.

Official Title
-----------------
Telerehabilitation for Veteran Lung Cancer Survivors Following Curative Intent Therapy

Conditions
-----------------
Lung Cancer, Lung Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Veterans with a history of stage I-IIIA 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators adapted a home-based, video telerehabilitation program for patients with chronic obstructive pulmonary disease, shown to be associated with reduced 30-day readmissions following acute hospitalizations. Home-based pulmonary rehabilitation with minimal resources has also been shown to be equivalent to center-based pulmonary rehabilitation. The program will consist of essential components of pulmonary rehabilitation: 1) exercise, 2) education, and 3) behavioral support. A board-certified physical therapist trained in telehealth, VA Video Connect (VVC), and motivational interviewing will deliver telerehabilitation. The education and behavioral support program will be informed by Veteran lung cancer survivors' health goals, knowledge of outcome expectations on exercise and rehabilitation, and perceived self-efficacy and impediments towards telehealth technology.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br>Telerehabilitation intervention consisting of exercise training, education, and behavioral support | Behavioral: Telerehabilitation<br>* Telerehabilitation intervention consisting of exercise training, education, and behavioral support<br>|
| No Intervention: Control<br>No intervention arm, with assessment of functional and patient-reported outcomes only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile Six-Minute Walk Distance | Assessment of functional capacity | Difference in changes in Mobile Six-Minute Walk Distance between baseline and week 12 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Second Arm Curls | Assessment of upper extremity strength | Difference in changes in 30-Second Arm Curls between baseline and week 12 and week 24 | 
| 30-Second Chair-Stand | Assessment of lower extremity strength | Difference in changes in 30-Second Chair-Stand between baseline and week 12 and week 24 | 
| Timed Up and Go | Assessment of balance and mobility | Difference in changes in Timed Up and Go between baseline and week 12 and week 24 | 
| Self-Efficacy for Exercise Scale | The Self-Efficacy for Exercise Scale is a 9-item questionnaire that assesses self-reported exercise self-efficacy. Responses are recorded on a 0 (not confident) to 10 (very confident) scale, summed, with total scores that range 0-90. Higher scores indicate higher levels of self-efficacy for exercise. | Difference in changes in Self-Efficacy for Exercise Scale between baseline and week 12 and week 24 | 
| European Organization for Research and Treatment Cancer QoL Questionnaire Core 30 and Lung Cancer Module 29 (C30/LC29) | The C30/L29 assesses general and cancer-/lung cancer-related quality of life (QoL) domains. Responses are recorded on a numerical rating scale and transformed to scores that range 0 to 100. For functional and general QoL domains - higher scores indicate higher levels of functioning and QoL. For symptom domains, higher scores indicate higher levels of symptom burden. The investigators will use the C30/L29 to assess differences in changes in self-reported physical function, social function, dyspnea, fatigue, sleep difficulties, and general and cancer-related quality of life between baseline and week 12 and week 24. | Difference in changes in C30/LC29 between baseline and week 12 and week 24 | 
| Katz Index of Independence in Activities of Daily Living | This questionnaire assesses older patients' abilities to perform 6 activities of daily living independently (bathing, dressing, toileting, transferring, continence, and feeding). Responses are recorded as 0 (dependent) or 1 (independent) and summed, with total scores ranging 0 to 6. Higher scores indicate higher levels of functioning and independence. | Difference in changes in Katz Index of Independence in Activities of Daily Living between baseline and week 12 and week 24 | 
| Hospital Anxiety and Depression Scale | This 14-item questionnaire assesses levels of anxiety and depressive symptoms. Responses are recorded on a 0 to 3 scale, summed, with scores that range from 0 to 21 for either anxiety or depressive symptoms. Higher scores indicate higher levels of anxiety/depressive symptoms. | Difference in changes in Hospital Anxiety and Depression Scale between baseline and week 12 and week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Exercise training, Survivorship care, Symptom control, US Veterans, Telemedicine