Malignant Peritoneal Neoplasm Clinical Trial
Official title:
Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 21 days | |
Secondary | Change in Daily Steps for Participants Before and After Major Oncologic Surgery | This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported. | baseline and 90 days | |
Secondary | Change in Short Physical Performance Battery (SPPB) | 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. | baseline and 90 days | |
Secondary | Change in Duration of 400-meter Walk | 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. | baseline and 90 days | |
Secondary | Change in Pepper Assessment Tool for Disability (PAT-D) | 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. | baseline and 90 days | |
Secondary | Change in the Mobility Assessment Tool-Short Form (MAT-sf). | 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. | baseline and 90 days | |
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. | baseline and 90 days | |
Secondary | Change in Health-related Quality of Life (FACT-G) Questionnaire | 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). | baseline and 90 days | |
Secondary | Change in Pain Assessment -Pain Visual Analog Scale, (PVAS) | 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. | baseline and 90 days | |
Secondary | Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS). | 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. | baseline and 90 days |
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