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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02356471
• Date of registration: 29/01/2015
• Prospective Registration: Yes
• Primary sponsor: Wake Forest University Health Sciences
• Public title: Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
• Scientific title: Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
• Date of first enrolment: March 2015
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02356471
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Clancy Clark
• Affiliation: Wake Forest University Health Sciences

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malignant Gastrointestinal Neoplasm

Malignant Peritoneal Neoplasm

Intervention(s)

Other: Quality-of-Life Assessment

Device: Management of Therapy Complications Fitbit Zip (portable pedometer device)

Other: Questionnaire Administration

Primary Outcome(s)

Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period [Time Frame: 21 days]

Secondary Outcome(s)

Change in Duration of 400-meter Walk [Time Frame: baseline and 90 days]

Change in Pain Assessment -Pain Visual Analog Scale, (PVAS) [Time Frame: baseline and 90 days]

Change in CHAMPS Between the Pre- and Post-operative Period [Time Frame: baseline and 90 days]

Change in Daily Steps for Participants Before and After Major Oncologic Surgery [Time Frame: baseline and 90 days]

Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS). [Time Frame: baseline and 90 days]

Change in Short Physical Performance Battery (SPPB) [Time Frame: baseline and 90 days]

Change in the Mobility Assessment Tool-Short Form (MAT-sf). [Time Frame: baseline and 90 days]

Change in Health-related Quality of Life (FACT-G) Questionnaire [Time Frame: baseline and 90 days]

Change in Pepper Assessment Tool for Disability (PAT-D) [Time Frame: baseline and 90 days]

Secondary ID(s)

NCI-2015-00097

CCCWFU 02114

P30CA012197

IRB00031577

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Results

• Results available: Yes
• Date Posted: 27/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02356471