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2015-12
2017-07
2017-07
14
NCT02680990
Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
INTERVENTIONAL
Resilience and Exercise in Advanced Cancer Treatment
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-11-25 | N/A | 2018-02-26 |
2016-02-09 | N/A | 2018-02-28 |
2016-02-12 | N/A | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Exercise Education Distribution of exercise education materials | OTHER: Exercise Education
|
| EXPERIMENTAL: Band Together A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy. | BEHAVIORAL: Band Together
|
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
