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This study will evaluate whether a remotely delivered exercise program can improve chemotherapy tolerability in patients with gastrointestinal or lung cancer receiving chemotherapy.
In this decentralized, digital randomized clinical trial, up to 120 adults with gastrointestinal or lung cancer will be randomized to either a home-based aerobic and resistance exercise program or home-based progressive stretching program. All study activities will be conducted remotely using digital technologies and home-based assessments. Participants in both groups will receive Bluetooth-enabled wearable devices for monitoring physical activity, body weight, blood pressure, and other health measures.
The primary objective is to determine whether exercise improves chemotherapy relative dose intensity compared with stretching. The intervention will continue throughout chemotherapy treatment or for up to 32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | The exercise group will engage in aerobic and muscle-strengthening activities. |
|
| Stretching | Active Comparator | The stretching group will engage in whole-body static stretching activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | The exercise group will be provided with Bluetooth-enabled devices and home exercise equipment. Participants will meet with an exercise trainer weekly to learn how to engage in the exercise program. |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy Relative Dose Intensity | The ratio of the delivered dose intensity to the standard or planned dose intensity. | Up to 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcus Perez | Contact | 407-303-5642 | Marcus.Perez@AdventHealth.com | |
| Abigail Tice, Ph.D. | Contact | Abigail.Tice@AdventHealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Justin Brown, Ph.D. | AdventHealth | Principal Investigator |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004194 | Disease |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Stretching | Behavioral | The stretching group will be provided with Bluetooth-enabled devices. Participants will meet with an exercise trainer weekly to learn how to engage in the stretching program. |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |