Physical Activity In Gastrointestinal Cancer

NCT03331406 | Completed

• 1 other identifier: 17-350
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Gastrointestinal Cancer; Physical Activity

Keywords

Metastatic gastrointestinal cancer; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of Retention

  12 Weeks

• Number of participants that complete assessment procedures

  12 Weeks

• Number of participants with adverse events

  12 Weeks

Study Arms (1)

12-week physical activity program

EXPERIMENTAL

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

Interventions

Physical Activity Program OTHER

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

12-week physical activity program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Start of trial:
• 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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 35722047 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Behavior

Study Officials

• Jeffrey Meyerhardt, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)