Trial Outcomes & Findings for Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery (NCT NCT02356471)

NCT ID: NCT02356471

Last Updated: 2018-09-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2018-09-27

Participant Flow

Participant milestones

Measure	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. 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 Study STARTED	34
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Supportive Care (Consumer-based Activity Monitor) n=34 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Age, Continuous	70.99 years STANDARD_DEVIATION 5.28 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

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

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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=28 Participants 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

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

9 Participants

SECONDARY outcome

Timeframe: baseline and 90 days

Population: 16 subjects had sufficient data for partial analysis.

This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=16 Participants 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

Change in Daily Steps for Participants Before and After Major Oncologic Surgery

-2573 steps Interval -2685.0 to -2461.0

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 9 subjects had SPPB measured at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=9 Participants 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

Change in Short Physical Performance Battery (SPPB)

0 units on a scale Interval -1.0 to 2.0

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 10 subjects had 400m walk measured at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=10 Participants 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

Change in Duration of 400-meter Walk

-69.5 seconds Interval -166.1 to 30.6

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Data were not collected and therefore analysis cannot performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 7 subjects had MAT-sf measured at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=7 Participants 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

Change in the Mobility Assessment Tool-Short Form (MAT-sf).

4.52 units on a scale Interval -0.465 to 5.42

SECONDARY outcome

Timeframe: baseline and 90 days

Population: 5 subjects have CHAMPs data at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=5 Participants 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

Change in CHAMPS Between the Pre- and Post-operative Period

-1 score on a scale Interval -1.0 to 2.0

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 6 subjects reported FACT-G at 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).

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=6 Participants 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

Change in Health-related Quality of Life (FACT-G) Questionnaire

-1 units on a scale Interval -1.0 to 2.0

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 6 subjects had pain VAS measured at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=6 Participants 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

Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)

21 units on a scale Interval 3.0 to 34.5

SECONDARY outcome

Timeframe: baseline and 90 days

Population: Only 6 subjects reported fatigue VAS at 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.

Outcome measures

Measure

Supportive Care (Consumer-based Activity Monitor) n=6 Participants 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

Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).

6 units on a scale Interval 0.0 to 25.5

Adverse Events

Supportive Care (Consumer-based Activity Monitor)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Clancy Clark

Wake Forest University Health Sciences

Phone: 336-716-7207

Email: cjclark@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place