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Completed

NCT Number: NCT03331406

Physical Activity In Gastrointestinal Cancer

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Physical activity program

Other

12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

Primary outcomes

  1. Rate of Accrual

    Time frame: 12 months

    Recruit 20 patients within 12 months

  2. 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

  1. Rate of Retention

    Time frame: 12 Weeks

    Proportion of participants who complete the study

  2. Number of participants that complete assessment procedures

    Time frame: 12 Weeks

    Physical function testing and questionnaire collection

  3. Number of participants with adverse events

    Time frame: 12 Weeks

    Falls, hospitalizations, and musculoskeletal injury

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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