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

• ClinicalTrials.gov Identifier: NCT02356471
• Recruitment Status: Completed
• First Posted: February 5, 2015
• Results First Posted: August 27, 2018
• Last Update Posted: September 27, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: January 29, 2015
• First Posted Date: February 5, 2015
• Results First Submitted Date: May 1, 2018
• Results First Posted Date: August 27, 2018
• Last Update Posted Date: September 27, 2018
• Study Start Date: March 2015
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2018)

Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period [ Time Frame: 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.

Original Primary Outcome Measures (submitted: February 4, 2015)

Number of patients who self-report wearing the consumer-based activity monitor at least 16 days of the 21 day period [ Time Frame: 90 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 divided by the total number of patients enrolled. This proportion and corresponding confidence intervals will be calculated. Subject adherence and retention will be evaluated.

Current Secondary Outcome Measures (submitted: July 27, 2018)

• Change in Daily Steps for Participants Before and After Major Oncologic Surgery [ Time Frame: 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) [ Time Frame: 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 Duration of 400-meter Walk [ Time Frame: 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 Pepper Assessment Tool for Disability (PAT-D) [ Time Frame: 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). [ Time Frame: 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 CHAMPS Between the Pre- and Post-operative Period [ Time Frame: 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 Health-related Quality of Life (FACT-G) Questionnaire [ Time Frame: 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 Pain Assessment -Pain Visual Analog Scale, (PVAS) [ Time Frame: 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.
• Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS). [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
• Official Title: Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Malignant Gastrointestinal Neoplasm
• Malignant Peritoneal Neoplasm

Intervention

• Device: Management of Therapy Complications Fitbit Zip (portable pedometer device)
  Use pedometer to monitor physical activity
  Other Name: complications of therapy, management of
• Other: Questionnaire Administration
  Ancillary studies
• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment

Study Arms

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.

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 24, 2016): 34
• Original Estimated Enrollment (submitted: February 4, 2015): 38
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02356471
• Other Study ID Numbers: IRB00031577; NCI-2015-00097 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CCCWFU 02114 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University ); P30CA012197 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wake Forest University Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Wake Forest University Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Clancy Clark; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: August 2018