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

NCT ID: NCT02356471

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility and adherence of using a consumer-based activity monitor during the preoperative period both in the hospital as well as at home.

SECONDARY OBJECTIVES:

I. To evaluate the ability of a consumer-based activity monitor to demonstrate a 50% decrease in average daily steps for participants before and after major oncologic surgery.

II. To characterize in-home movement among older cancer patients. III. To compare in-home CAM data to in-clinic pre- and post-operative mobility testing using the Short Physical Performance Battery (SPPB).

IV. To compare in-home CAM data to pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D) and the Mobility Assessment Tool-Short Form (MAT-sf).

V. To compare in-home CAM data to self-reported daily activity data during the pre- and post-operative period.

VI. To determine estimates of future study accrual, adherence, and drop-out. VII. To obtain participant feedback from participants to determine potential study opportunities and barriers.

VIII. To identify potential key stakeholders and potential patient partners for development of future grant submissions.

IX. To summarize baseline cognitive screens, physical assessment questionnaire (Pepper Assessment Tool for Disability, PAT-D), mobility assessment tool-short form (MAT-sf), health-related quality of life (FACIT-G) questionnaire, activity questionnaire (Community Healthy Activities Model Program for Seniors [CHAMPS]), pain assessment (Pain Visual Analog Scale, PVAS), fatigue assessment (Fatigue Visual Analog Scale, FVAS), and physical function testing (Short Physical Performance Battery and time to complete 400-meter walk).

X. CAM data will be compared with research grade activity data provided by the ActiGraph.

OUTLINE:

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.

After completion of study, patients are followed up at 21 and 90 days.

Conditions

Malignant Gastrointestinal Neoplasm; Malignant Peritoneal Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (consumer-based activity monitor)

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.

Group Type: EXPERIMENTAL

Management of Therapy Complications Fitbit Zip (portable pedometer device)

Intervention Type: DEVICE

Use pedometer to monitor physical activity

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Management of Therapy Complications Fitbit Zip (portable pedometer device)

Use pedometer to monitor physical activity

Intervention Type: DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

complications of therapy, management of; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clancy Clark

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2015-00097

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 02114

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00031577

Identifier Type: -

Identifier Source: org_study_id