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

Not Applicable

Completed

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

• Registration Number: NCT02356471
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Study Start: 2015-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-05-01
• Results First Submitted QC: 2018-07-27
• Status Verified: 2018-08
• Results First Posted: 2018-08-27
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (consumer-based activity monitor)	Management of Therapy Complications Fitbit Zip (portable pedometer device)	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.
Supportive care (consumer-based activity monitor)	Quality-of-Life Assessment	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.
Supportive care (consumer-based activity monitor)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in Daily Steps for Participants Before and After Major Oncologic Surgery	baseline and 90 days	This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.
Change in Short Physical Performance Battery (SPPB)	baseline and 90 days	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.
Change in Health-related Quality of Life (FACT-G) Questionnaire	baseline and 90 days	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).
Change in Pepper Assessment Tool for Disability (PAT-D)	baseline and 90 days	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.
Change in the Mobility Assessment Tool-Short Form (MAT-sf).	baseline and 90 days	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.
Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).	baseline and 90 days	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.
Change in Duration of 400-meter Walk	baseline and 90 days	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.
Change in CHAMPS Between the Pre- and Post-operative Period	baseline and 90 days	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.
Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)	baseline and 90 days	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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States