Physical Activity In Gastrointestinal Cancer

Not Applicable

Completed

• Conditions: Metastatic Gastrointestinal Cancer; Physical Activity
• Interventions: Other: Physical Activity Program

• Registration Number: NCT03331406
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-12-01
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
12-week physical activity program	Physical Activity Program	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.

Primary Outcome Measures

Name	Time	Method
Number of participants that adhered to physical activity program	12 Weeks	Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.
Rate of Accrual	12 months	Recruit 20 patients within 12 months

Secondary Outcome Measures

Name	Time	Method
Rate of Retention	12 Weeks	Proportion of participants who complete the study
Number of participants with adverse events	12 Weeks	Falls, hospitalizations, and musculoskeletal injury
Number of participants that complete assessment procedures	12 Weeks	Physical function testing and questionnaire collection

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States