Lung Cancer, Metastatic Lung Cancer, Non Small Cell Lung Cancer
Conditions
Keywords
lung cancer, exercise, non small cell lung cancer
Brief summary
The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.
Detailed description
This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually. Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB. Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. Secondary Objectives 1. To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 2. To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 3. To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 4. To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 5. To compare the proportion of patients who are "fatigued," defined as a FACT-F score of \<43 at post-intervention between the exercise and usual care arms. 6. To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
Interventions
BEHAVIORALExercise Intervention
Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Known diagnosis of locally advanced (stage III) or metastatic NSCLC 3. Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy 1. Patients receiving maintenance therapy refers to patients with stable disease or partial response to therapy, including patients who have had a history of disease progression but are currently stable or responding to a different therapy 2. Patients previously receiving chemotherapy are eligible as long as at least one month has elapsed since completing chemotherapy. Those currently receiving chemotherapy are not eligible. 4. Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program a.Participants must have internet access and equipment to participate in virtual exercise 5. ECOG performance status of 0-2
Exclusion criteria
1. Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ 2. Unable to participate in the supervised home-based exercise program as determined by the MOVE program 3. Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to: * Advanced heart failure * Advanced respiratory disease requiring home oxygen use * Uncontrolled psychiatric disorders * History of fragility fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported fatigue | baseline, week 12, and week 24 | Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiorespiratory fitness | baseline, week 12, and week 24 | Measured by VO2peak, estimated as time on the treadmill |
| Change in physical performance battery | baseline, week 12, and week 24 | total score on short physical performance battery |
| Change in muscle mass | baseline, and week 12 | measured by mg/kg2 on HU on CT scans |
| Change in muscle density | baseline, and week 12 | measured by mg/kg2 on HU on CT scans |
| Change in depression | baseline, week 12, and week 24 | measured by total score of HADS survey |
| Proportion of patients who are "fatigued" | baseline, week 12, and week 24 | measured by FACT-F score of \<43 |
| Uptake of the study | date open to accrual until closed to accrual, up to 5 years | the proportion of total patients approached, screened, and ultimately completing the baseline assessments |
| Adherence with the intervention defined | baseline to post 12-week intervention | the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTarah J Ballinger, MD
Indiana University
Outcome results
None listed