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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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
Hide 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%
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
16 subjects had sufficient data for partial analysis.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 subjects had SPPB measured at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 subjects had 400m walk measured at baseline and 90 days
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore analysis cannot performed.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 subjects had MAT-sf measured at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects have CHAMPs data at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 subjects reported FACT-G at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 subjects had pain VAS measured at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 subjects reported fatigue VAS at baseline and 90 days.
Arm/Group Title Supportive Care (Consumer-based Activity Monitor)
Hide 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)
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)
Hide 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%) 
Hide Serious Adverse Events
Supportive Care (Consumer-based Activity Monitor)
Affected / at Risk (%)
Total   0/28 (0.00%) 
Hide 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%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Clancy Clark
Organization: Wake Forest University Health Sciences
Phone: 336-716-7207
EMail: cjclark@wakehealth.edu
Layout table for additonal information
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