REACT: Resilience and Exercise in Advanced Cancer Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Exercise Education Distribution of exercise education materials |
Other: Exercise Education
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.
|
| Experimental: Band Together A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy. |
Behavioral: Band Together
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Feasibility of Large-Scale Trial: Adherence & Contamination [Throughout the course of neoadjuvant therapy (on average 10-12 weeks)]
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.
Secondary Outcome Measures
- Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate [Completion of neoadjuvant therapy (on average 10-12 weeks)]
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.
- Exercise Partner Benefits [Completion of neoadjuvant therapy (on average 10-12 weeks)]
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.
- Change in grip strength and upper body strength as a result of intervention [Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)]
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.
- Assessing the interaction between frailty and the Band Together program [Completion of neoadjuvant therapy (on average 10-12 weeks)]
Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older
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New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
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Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
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Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
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The ability to speak and read English.
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The ability to provide informed consent.
Exclusion Criteria:
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Angina (stable or unstable)
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Paraplegia or quadriplegia
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Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
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Patients who have already started neoadjuvant chemotherapy at other institutions.
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Presence of metastatic disease.
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Gastric or pancreatic histologies other than adenocarcinoma.
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Pregnant women.
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Prisoners
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Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Amanda B Cooper, MD, Penn State College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Bollwein J, Diekmann R, Kaiser MJ, Bauer JM, Uter W, Sieber CC, Volkert D. Dietary quality is related to frailty in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2013 Apr;68(4):483-9. doi: 10.1093/gerona/gls204. Epub 2012 Oct 12.
- Cooper AB, Slack R, Fogelman D, Holmes HM, Petzel M, Parker N, Balachandran A, Garg N, Ngo-Huang A, Varadhachary G, Evans DB, Lee JE, Aloia T, Conrad C, Vauthey JN, Fleming JB, Katz MH. Characterization of Anthropometric Changes that Occur During Neoadjuvant Therapy for Potentially Resectable Pancreatic Cancer. Ann Surg Oncol. 2015 Jul;22(7):2416-23. doi: 10.1245/s10434-014-4285-2. Epub 2014 Dec 18.
- Dale W, Hemmerich J, Kamm A, Posner MC, Matthews JB, Rothman R, Palakodeti A, Roggin KK. Geriatric assessment improves prediction of surgical outcomes in older adults undergoing pancreaticoduodenectomy: a prospective cohort study. Ann Surg. 2014 May;259(5):960-5. doi: 10.1097/SLA.0000000000000226.
- van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
- STUDY00002745