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

Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02356471

Enrollment

Registered

2015-02-05

Start date

2015-03-31

Completion date

2016-10-31

Last updated

2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Gastrointestinal Neoplasm, Malignant Peritoneal Neoplasm

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.

Interventions

DEVICEManagement of Therapy Complications Fitbit Zip (portable pedometer device)

Use pedometer to monitor physical activity

OTHERQuestionnaire Administration

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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).
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	34
Total	34

Arm

Count

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

Total

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 28
other Total, other adverse events	0 / 28
serious Total, serious adverse events	0 / 28

Outcome results

Primary

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

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

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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Supportive Care (Consumer-based Activity Monitor)	Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period	9 Participants

Secondary

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

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.