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

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Conditions: Malignant Gastrointestinal Neoplasm; Malignant Peritoneal Neoplasm
• Interventions: Device: Management of Therapy Complications Fitbit Zip (portable pedometer device); Other: Questionnaire Administration; Other: Quality-of-Life Assessment
• Enrollment: 34

Participant Flow

Recruitment Details
Pre-assignment Details

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 Number of Baseline Participants		34
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	2 5.9%
	>=65 years	32 94.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants
		70.99 (5.28)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	Female	12 35.3%
	Male	22 64.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	34 100.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	4 11.8%
	White	29 85.3%
	More than one race	0 0.0%
	Unknown or Not Reported	1 2.9%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	34 participants
		34 100.0%

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
Overall Number of Participants Analyzed	28
Measure Type: Count of Participants; Unit of Measure: Participants
	9 32.1%

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
Overall Number of Participants Analyzed	16
Median (Inter-Quartile Range); Unit of Measure: steps
	-2573; (-2685 to -2461)

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
Overall Number of Participants Analyzed	9
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	0; (-1 to 2)

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
Overall Number of Participants Analyzed	10
Median (Inter-Quartile Range); Unit of Measure: seconds
	-69.5; (-166.1 to 30.6)

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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

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
Overall Number of Participants Analyzed	7
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	4.52; (-0.465 to 5.42)

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
Overall Number of Participants Analyzed	5
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-1; (-1 to 2)

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
Overall Number of Participants Analyzed	6
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	-1; (-1 to 2)

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
Overall Number of Participants Analyzed	6
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	21; (3 to 34.5)

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
Overall Number of Participants Analyzed	6
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	6; (0 to 25.5)

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 (%)
Total	0/28 (0.00%)
Serious Adverse Events
	Supportive Care (Consumer-based Activity Monitor)
	Affected / at Risk (%)
Total	0/28 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Supportive Care (Consumer-based Activity Monitor)
	Affected / at Risk (%)
Total	0/28 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Dr. Clancy Clark
• Organization: Wake Forest University Health Sciences
• Phone: 336-716-7207
• EMail: cjclark@wakehealth.edu

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: 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 )
• First Submitted: January 29, 2015
• First Posted: February 5, 2015
• Results First Submitted: May 1, 2018
• Results First Posted: August 27, 2018
• Last Update Posted: September 27, 2018