Malignant Gastrointestinal NeoplasmNCT02356471
Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
A study testing Management of Therapy Complications Fitbit Zip (portable pedometer device), Questionnaire Administration and Quality-of-Life Assessment in people with Malignant Gastrointestinal Neoplasm and Malignant Peritoneal Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Malignant Gastrointestinal Neoplasm, Malignant Peritoneal Neoplasm
- What is being tested?
- Management of Therapy Complications Fitbit Zip (portable pedometer device), Questionnaire Administration and Quality-of-Life Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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).
- 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.
- Being tested
- Management of Therapy Complications Fitbit Zip (portable pedometer device), Questionnaire Administration, Quality-of-Life Assessment
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Therapy Complications Fitbit Zip (portable pedometer device)Device
Also called complications of therapy, management of
Use pedometer to monitor physical activity
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (consumer-based activity monitor) | Experimental | 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. Receives: Device: Management of Therapy Complications Fitbit Zip (portable pedometer device); Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (9)
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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).
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
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.
Measured: baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Gastrointestinal NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clancy Clark, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356471
- Sponsor's protocol ID
- IRB00031577
- Other IDs
- NCI-2015-00097, CCCWFU 02114, P30CA012197
- Status last verified
- Aug 2018
- First submitted
- 29 Jan 2015
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
- ClinicalTrials.gov ID
- NCT02356471
- Acronym / sponsor ID
- IRB00031577
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Posted 27 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
- 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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (consumer-based activity monitor) | Experimental | Device: Management of Therapy Complications Fitbit Zip (portable pedometer device), Other: Questionnaire Administration, Other: Quality-of-Life AssessmentPatients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management of Therapy Complications Fitbit Zip (portable pedometer device)Also: complications of therapy, management ofUse pedometer to monitor physical activity | Device | Supportive care (consumer-based activity monitor) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (consumer-based activity monitor) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (consumer-based activity monitor) |
Primary outcome
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
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.
9 secondary outcomes
Change in Daily Steps for Participants Before and After Major Oncologic Surgery
Time frame: baseline and 90 days
Change in Short Physical Performance Battery (SPPB)
Time frame: baseline and 90 days
Change in Duration of 400-meter Walk
Time frame: baseline and 90 days
Change in Pepper Assessment Tool for Disability (PAT-D)
Time frame: baseline and 90 days
Change in the Mobility Assessment Tool-Short Form (MAT-sf).
Time frame: baseline and 90 days
Change in CHAMPS Between the Pre- and Post-operative Period
Time frame: baseline and 90 days
Change in Health-related Quality of Life (FACT-G) Questionnaire
Time frame: baseline and 90 days
Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)
Time frame: baseline and 90 days
Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).
Time frame: baseline and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clancy Clark principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of Therapy Complications Fitbit Zip (portable pedometer device), Questionnaire Administration and Quality-of-Life Assessment in people with Malignant Gastrointestinal Neoplasm and Malignant Peritoneal Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.