A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Gastrointestinal Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of Accrual
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.
Detailed Description
The physical activity program is 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training. * The goal of the aerobic training is to complete 150 minutes per week of brisk walking. * The goals of the strength, flexibility, and balance training are to engage in these activities twice per week.
Investigators
Jeffrey A. Meyerhardt, MD
Prinicipal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Start of trial:
- •A three-month of strict inclusion criteria (Phase 1).
- •At the end of three-months, if at least six participants have not been accrued, inclusion criteria will be expanded for a second three-month recruitment phase (Phase 2).
- •At the end of six-months, an average of two patients per month has not been accrued, a further expand inclusion criteria (Phase 3).
- •Phase 1 (most strict) Eligibility criteria include:
- •Voluntary, signed informed consent;
- •Diagnosis of histologically-confirmed esophageal, gastric, pancreatic, or colorectal that is metastatic or locally-advanced (unresectable);
- •First-line cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior adjuvant therapy if completed ≥6 months prior to start of first line chemotherapy for metastatic disease);
- •Age greater than 65 years;
- •Baseline weight-bearing physical activity less than 150 min∙wk-1 using the Paffenbarger physical activity questionnaire;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Accrual
Time Frame: 12 months
Recruit 20 patients within 12 months
Number of participants that adhered to physical activity program
Time Frame: 12 Weeks
Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.
Secondary Outcomes
- Rate of Retention(12 Weeks)
- Number of participants with adverse events(12 Weeks)
- Number of participants that complete assessment procedures(12 Weeks)