Physical Activity In Gastrointestinal Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Metastatic Gastrointestinal Cancer
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 12-week 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.

Other: Physical Activity Program; 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jeffrey Meyerhardt, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Brown JC, Brighton E, Campbell N, McCleary NJ, Abrams TA, Cleary JM, Enzinger PC, Ng K, Rubinson D, Wolpin BM, Yurgelun MB, Meyerhardt JA. Physical activity in older adults with metastatic gastrointestinal cancer: a pilot and feasibility study. BMJ Open Sport Exerc Med. 2022 May 30;8(2):e001353. doi: 10.1136/bmjsem-2022-001353. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Metastatic gastrointestinal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 17-350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No