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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02356471
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 19.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Gastrointestinal Neoplasm; Malignant Peritoneal Neoplasm	Device: Management of Therapy Complications Fitbit Zip (portable pedometer device); Other: Questionnaire Administration; Other: Quality-of-Life Assessment	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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.

2. 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).

3. 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).

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

5. 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.

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

7. 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).

8. 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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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).

8. 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.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02356471
• Other Study ID Numbers: IRB00031577; NCI-2015-00097; CCCWFU 02114; P30CA012197
• First Posted: Feb 5, 2015
• Last Update Posted: Sep 27, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Peritoneal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
STARTED	34
COMPLETED	28
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 5.9%
>=65 years	32 94.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.99 (5.28)
Sex: Female, Male (Count of Participants)
Female	12 35.3%
Male	22 64.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	34 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 11.8%
White	29 85.3%
More than one race	0 0%
Unknown or Not Reported	1 2.9%
Region of Enrollment (Count of Participants)
United States	34 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

34 patients enrolled in study. 28 patients had data collected. Due to challenges associated with data collection, partial data was collected for 18 patients.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	28
Count of Participants [Participants]	9 26.5%

2. Secondary Outcome

Title	Change in Daily Steps for Participants Before and After Major Oncologic Surgery
Description	This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

16 subjects had sufficient data for partial analysis.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	16
Median (Inter-Quartile Range) [steps]	-2573

3. Secondary Outcome

Title	Change in Short Physical Performance Battery (SPPB)
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 9 subjects had SPPB measured at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	9
Median (Inter-Quartile Range) [units on a scale]	0

4. Secondary Outcome

Title	Change in Duration of 400-meter Walk
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 10 subjects had 400m walk measured at baseline and 90 days

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	10
Median (Inter-Quartile Range) [seconds]	-69.5

5. Secondary Outcome

Title	Change in Pepper Assessment Tool for Disability (PAT-D)
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Data were not collected and therefore analysis cannot performed.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

6. Secondary Outcome

Title	Change in the Mobility Assessment Tool-Short Form (MAT-sf).
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 7 subjects had MAT-sf measured at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	7
Median (Inter-Quartile Range) [units on a scale]	4.52

7. Secondary Outcome

Title	Change in CHAMPS Between the Pre- and Post-operative Period
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

5 subjects have CHAMPs data at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	5
Median (Inter-Quartile Range) [score on a scale]	-1

8. Secondary Outcome

Title	Change in Health-related Quality of Life (FACT-G) Questionnaire
Description	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).
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 6 subjects reported FACT-G at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	6
Median (Inter-Quartile Range) [units on a scale]	-1

9. Secondary Outcome

Title	Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 6 subjects had pain VAS measured at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	6
Median (Inter-Quartile Range) [units on a scale]	21

10. Secondary Outcome

Title	Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).
Description	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.
Time Frame	baseline and 90 days

Outcome Measure Data

Analysis Population Description

Only 6 subjects reported fatigue VAS at baseline and 90 days.

Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	6
Median (Inter-Quartile Range) [units on a scale]	6

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	No adverse events occurred for study. Definitions used for adverse events did not differ from clinicaltrials.gov
Arm/Group Title	Supportive Care (Consumer-based Activity Monitor)
Arm/Group Description	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. Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
All Cause Mortality
	Supportive Care (Consumer-based Activity Monitor)
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Serious Adverse Events
	Supportive Care (Consumer-based Activity Monitor)
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Supportive Care (Consumer-based Activity Monitor)
	Affected / at Risk (%)	# Events
Total	0/28 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.