Resilience and Exercise in Advanced Cancer Treatment

Study Overview
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Brief Summary
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This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.

Detailed Description
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A growing body of evidence suggests host resilience (lack of frailty, skeletal muscle reserve, etc.) may impact early healing, recovery following neoadjuvant therapy and surgery, and long-term cancer-free survival. It is well-recognized that resilience is enhanced in individuals with proper diet, sleep habits, and exercise. However, it is unknown whether such resilience can be enhanced by training programs initiated at the time of cancer diagnosis. Although exercise interventions may contribute to these improvements, it is unknown how willing and able these patients are to comply with an exercise regimen during the neoadjuvant therapy period. The aim of this study, therefore, is to evaluate compliance with and the efficacy of Band Together, an exercise program combining strength-training and aerobic exercise, in patients with aggressive GI malignancies undergoing neoadjuvant therapy.

Official Title
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Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy

Conditions
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Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction

Intervention / Treatment
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* Behavioral: Band Together
* Other: Exercise Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction. Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation. Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers. The ability to speak and read English. The ability to provide informed consent. Exclusion Criteria: Angina (stable or unstable) Paraplegia or quadriplegia Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands. Patients who have already started neoadjuvant chemotherapy at other institutions. Presence of metastatic disease. Gastric or pancreatic histologies other than adenocarcinoma. Pregnant women. Prisoners Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Education<br>Distribution of exercise education materials | Other: Exercise Education<br>* Education will consist of counseling by the healthcare provider with supplemental handouts from the American College of Sports Medicine and the National Institute on Aging/ National Institutes of Health.<br>|
| Experimental: Band Together<br>A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy. | Behavioral: Band Together<br>* Band Together is a strength training program utilizing resistance bands with progressively increasing resistance, ranging from 3 to 35 pounds. Sessions are to be completed 3 times a week and involve 3 sets of 6 exercises: 1. chair stands, 2. chest press, 3. shoulder press, 4. arm curls, 5. pulls, and 6. calf raises. In addition, Band Together participants will be asked to work up to a walking goal of 10,000 additional steps per week.<br>* Other names: strength training and walking program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Large-Scale Trial: Adherence & Contamination | The mean adherence rates (percentage of prescribed sessions completed) in the intervention group will be determined based on weekly activity diaries. Activity diaries will be completed by the subject throughout their participation in the study and collected upon the end of participation. The mean contamination rates (completed exercise sessions) in the control group will also be determined based on weekly activity diaries. | Throughout the course of neoadjuvant therapy (on average 10-12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate | Potential subjects will be screened using the Physical Activity Readiness Questionnaire; those who may not be ready to begin an exercise program will be ineligible. The proportion of patients who are PAR-Q ineligible will be compared to the proportion of patients who are eligible based on their PAR-Q results. The proportion of patients who are ineligible due to other exclusion criteria will also be compared. All eligible patients who decline to participate in the study will be asked to provide a reason for their decision; the proportion of potential subjects who decline will be compared to the proportion of subjects who do consent and are eligible. | Completion of neoadjuvant therapy (on average 10-12 weeks) | 
| Exercise Partner Benefits | The mean adherence rates (percentage of prescribed sessions completed) for subjects in the intervention group who have an exercise partner participate in ≥50% of their exercise sessions will be compared to those of subjects who have an exercise partner for <50% of their exercise sessions. | Completion of neoadjuvant therapy (on average 10-12 weeks) | 
| Change in grip strength and upper body strength as a result of intervention | Subjects will be tested before starting neoadjuvant therapy using a dynamometer and a hanging scale, and then again after completing neoadjuvant therapy, to determine if their grip strength and/or upper body strength have changed from baseline. | Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks) | 
| Assessing the interaction between frailty and the Band Together program | Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above. | Completion of neoadjuvant therapy (on average 10-12 weeks) |