Physical Activity In Gastrointestinal Cancer

Study Overview
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Brief Summary
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This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.

Detailed Description
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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.

Official Title
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A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer

Conditions
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Metastatic Gastrointestinal Cancer, Physical Activity

Intervention / Treatment
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* Other: Physical Activity Program


Participation Criteria
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Eligibility Criteria
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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; Eastern Cooperative Group Performance Status of 0, 1, or 2; Self-reported ability to walk 400-meters (approximately one city block) without sitting, leaning, or the help of another person or walker; Written physician approval; Life expectancy >3 months; English speaking. Phase 2 (less restrictive) Eligibility criteria will loosen: -- The minimum age from greater than 65, to greater than 55; Phase 3 (least restrictive) Eligibility criteria will add: -- The minimum age from greater than 55, to greater than 18. Exclusion Criteria Known or suspected brain or other central nervous system metastases; Uncontrolled cardiac or pulmonary disease; Pregnant or breast feeding; Any other condition that may impede testing of the study hypothesis, make it unsafe to engage in the physical activity program, or make the participant not available for end of study assessments (determined by the investigative team).

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-week physical activity program<br>The physical activity program is of moderate intensity and consists of aerobic, strength, flexibility, and balance training with a target duration of 150 minutes per week. At study start, participants will be provided with a pedometer to objectively monitor their aerobic activity, variable weight ankle weights and a medical journal to record physical activity. Exercise Trainer --A exercise trainer will be assigned to design a physical activity program. | Other: Physical Activity Program<br>* 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Accrual | Recruit 20 patients within 12 months | 12 months | 
| Number of participants that adhered to physical activity program | Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Retention | Proportion of participants who complete the study | 12 Weeks | 
| Number of participants that complete assessment procedures | Physical function testing and questionnaire collection | 12 Weeks | 
| Number of participants with adverse events | Falls, hospitalizations, and musculoskeletal injury | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic gastrointestinal cancer, Physical Activity