Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery

Completed · Not applicable

Conditions studied: Malignant Gastrointestinal Neoplasm, Malignant Peritoneal Neoplasm

In brief

This pilot clinical trial studies how well consumer-based activity monitor works in evaluating and measuring activity of older patients with abdominal cancer undergoing surgery. Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased post-surgery medical problems. With early identification of at-risk patients, CAM provide supervised exercise in the preoperative and postoperative periods to improve over mobility and potentially decrease preoperative complications among patients undergoing major abdominal surgery.

Key facts

Study ID

NCT02356471

Run by

Wake Forest University Health Sciences

People needed

34

Starts

2015-03-01

Expected to finish

2016-10-01

Last updated by the study team

2018-09-27

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) < 3
• Histologically or cytologically confirmed gastrointestinal or peritoneal malignancy
• Scheduled for major open abdominal oncologic surgery
• Able to walk without an assistive device
• Able to complete a minimum of 4 days of in-home activity monitoring before operation
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
• Ability to understand and complete the study survey instruments in English

You may not qualify if…

• Cerebrovascular accident (CVA) or stroke within the past 6 months
• Severe or symptomatic heart disease
• Currently residing in nursing or assisted living facility
• Neurologic disorder that impairs ambulation (e.g. Parkinson's)
• Actively undergoing treatment for a psychiatric illness
• Resting blood pressure > 160/100
• Clinically evident cognitive and/or behavioral impairment that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
• Current alcohol or other substance abuse or history of abuse within 6 months prior to screening
• Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
• Unable to understand and complete the study survey instruments in English

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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