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

NCT02356471 | Completed Results FDA Device

• 4 other identifiers: IRB00031577NCI-2015-00097CCCWFU 02114P30CA012197
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Gastrointestinal Neoplasm; Malignant Peritoneal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period

  Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.

  21 days

Secondary Outcomes (9)

• Change in Daily Steps for Participants Before and After Major Oncologic Surgery

  baseline and 90 days

• Change in Short Physical Performance Battery (SPPB)

  baseline and 90 days

• Change in Duration of 400-meter Walk

  baseline and 90 days

• Change in Pepper Assessment Tool for Disability (PAT-D)

  baseline and 90 days

• Change in the Mobility Assessment Tool-Short Form (MAT-sf).

  baseline and 90 days

Study Arms (1)

Supportive care (consumer-based activity monitor)

EXPERIMENTAL

Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.

Device: Management of Therapy Complications Fitbit Zip (portable pedometer device); Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Management of Therapy Complications Fitbit Zip (portable pedometer device) DEVICE

Use pedometer to monitor physical activity

Also known as: complications of therapy, management of

Supportive care (consumer-based activity monitor)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (consumer-based activity monitor)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (consumer-based activity monitor)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This feasibility study closed early due to slow accrual and inability to capture specific study variables. Small sample size limited study analysis and prevents reliable interpretation of data collected.

Results Point of Contact

• Title: Dr. Clancy Clark
• Organization: Wake Forest University Health Sciences

cjclark@wakehealth.edu

336-716-7207

Study Officials

• Clancy Clark

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 5, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 27, 2018
• Results First Posted: August 27, 2018

Record last verified: 2018-08

Locations

US (1)