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

Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Malignant Gastrointestinal Neoplasm; Malignant Peritoneal Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Management of Therapy Complications Fitbit Zip (portable pedometer device)

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: Management of Therapy Complications Fitbit Zip (portable pedometer device); Use pedometer to monitor physical activity; Other Names: complications of therapy, management of

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Steps for Participants Before and After Major Oncologic Surgery	This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.	baseline and 90 days
Change in Short Physical Performance Battery (SPPB)	This outcome measure is to compare pre- and post-operative mobility using the Short Physical Performance Battery (SPPB). Median (IQR) change in SPPB from baseline to 90 days is reported.The scale range is 0-16. Higher scores denotes better outcomes.	baseline and 90 days
Change in Duration of 400-meter Walk	This outcome measure is to compare pre- and post-operative mobility testing using the 400-meter walk. Median (IQR) change in 400 m walk from baseline to 90 days is reported. The duration it takes the participant to walk 400 meters will be recorded in seconds.	baseline and 90 days
Change in Pepper Assessment Tool for Disability (PAT-D)	This outcome measure is to compare pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D). Median (IQR) change in PAT-D is reported.	baseline and 90 days
Change in the Mobility Assessment Tool-Short Form (MAT-sf).	This outcome measure is to compare pre- and post-operative self-reported mobility using the Mobility Assessment Tool-Short Form (MAT-sf). Median (IQR) change in MAT-sf is reported. The score range is 30-80 and higher scores denotes better outcomes.	baseline and 90 days
Change in CHAMPS Between the Pre- and Post-operative Period	This outcome measure is to compare self-reported activity data (CHAMPS) during the pre- and post-operative period. Median (IQR) change in CHAMPS is reported. CHAMPS measures activity of the participant and how long they could do the activity. The score range is 0-108. Higher scores denotes better outcomes.	baseline and 90 days
Change in Health-related Quality of Life (FACT-G) Questionnaire	FACT-G is a 27-item compilation of general questions divided into 4 primary quality of life (QOL) domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The subscales are summed to produce a total score. The total score range is 0-108 and a higher score indicates better quality of life. Outcomes is to compare FACT-G at baseline and 90 days. Change in FACT-G is reported in median (IQR).	baseline and 90 days
Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)	The pain VAS is a unidimensional measure of pain intensity providing a range of scores from 0-100. A higher score indicates greater pain intensity. Change in median (IQR) pain score from baseline to 90 days is reported.	baseline and 90 days
Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).	The fatigue VAS is a unidimensional measure of fatigue providing a range of scores from 0-100. A higher score indicates greater fatigue. Change in median (IQR) fatigue score from baseline to 90 days is reported.	baseline and 90 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Clancy Clark, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Peritoneal Diseases; Gastrointestinal Diseases; Abdominal Neoplasms; Neoplasms; Peritoneal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: IRB00031577; P30CA012197 (U.S. NIH Grant/Contract); NCI-2015-00097 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 02114 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No