Back to resultsPhysical Activity In Gastrointestinal Cancer
Primary Purpose
Metastatic Gastrointestinal Cancer, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Program
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Gastrointestinal Cancer focused on measuring Metastatic gastrointestinal cancer, Physical Activity
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;
- 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).
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
12-week physical activity program
Arm Description
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.
Outcomes
Primary Outcome Measures
Rate of Accrual
Recruit 20 patients within 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.
Secondary Outcome Measures
Rate of Retention
Proportion of participants who complete the study
Number of participants that complete assessment procedures
Physical function testing and questionnaire collection
Number of participants with adverse events
Falls, hospitalizations, and musculoskeletal injury
Full Information
NCT ID
NCT03331406
First Posted
November 1, 2017
Last Updated
March 10, 2020
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03331406
Brief Title
Physical Activity In Gastrointestinal Cancer
Official Title
A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastrointestinal Cancer, Physical Activity
Keywords
Metastatic gastrointestinal cancer, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12-week physical activity program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Activity Program
Intervention Description
12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.
Primary Outcome Measure Information:
Title
Rate of Accrual
Description
Recruit 20 patients within 12 months
Time Frame
12 months
Title
Number of participants that adhered to physical activity program
Description
Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Rate of Retention
Description
Proportion of participants who complete the study
Time Frame
12 Weeks
Title
Number of participants that complete assessment procedures
Description
Physical function testing and questionnaire collection
Time Frame
12 Weeks
Title
Number of participants with adverse events
Description
Falls, hospitalizations, and musculoskeletal injury
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Meyerhardt, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35722047
Citation
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.
Results Reference
derived
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Physical Activity In Gastrointestinal Cancer
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