Clinical trial NCT02356471: Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
Official title: Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Gastrointestinal Neoplasm
Malignant Peritoneal Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period
timeFrame: 21 days
Secondary outcomes:
measure: Change in Daily Steps for Participants Before and After Major Oncologic Surgery
timeFrame: baseline and 90 days
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: baseline and 90 days
measure: Change in Duration of 400-meter Walk
timeFrame: baseline and 90 days
measure: Change in Pepper Assessment Tool for Disability (PAT-D)
timeFrame: baseline and 90 days
measure: Change in the Mobility Assessment Tool-Short Form (MAT-sf).
timeFrame: baseline and 90 days
measure: Change in CHAMPS Between the Pre- and Post-operative Period
timeFrame: baseline and 90 days
measure: Change in Health-related Quality of Life (FACT-G) Questionnaire
timeFrame: baseline and 90 days
measure: Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)
timeFrame: baseline and 90 days
measure: Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).
timeFrame: baseline and 90 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Clancy Clark
role: PRINCIPAL_INVESTIGATOR
References: