Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
NCT ID: NCT02715856
Last Updated: 2022-10-13
Study Results
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View full resultsBasic Information
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TERMINATED
NA
70 participants
INTERVENTIONAL
2016-04-13
2021-09-28
Brief Summary
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Detailed Description
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I. To develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases.
SECONDARY OBJECTIVES:
I. To evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance.
II. Limited efficacy testing of the remote surveillance program. III. To obtain information on acceptability of the mobile surveillance format by patients and clinicians.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.
GROUP II (MOBILE SURVEILLANCE): Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.
After completion of study, patients are followed up at 24-25 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group I (standard follow up, physical activity measurement)
Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.
Physical Activity Measurement
Undergo physical activity measurement
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Standard Follow-Up Care
Undergo standard follow-up care
Survey Administration
Ancillary studies
Group II (mobile surveillance)
Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.
Monitoring Device
Undergo surgical wound and physical activity monitoring
Physical Activity Measurement
Undergo physical activity measurement
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Standard Follow-Up Care
Undergo standard follow-up care
Survey Administration
Ancillary studies
Interventions
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Monitoring Device
Undergo surgical wound and physical activity monitoring
Physical Activity Measurement
Undergo physical activity measurement
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Standard Follow-Up Care
Undergo standard follow-up care
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are able to read and write English 3) Are 18 years or older
* Are willing and able to use a smartphone or tablet comfortably
* Have access to mobile hot spot, wireless internet, and/or cellular service
* Must have a caregiver or assistance at home who can assist with collecting physical therapy (PT) measures
Exclusion:
N/A
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Robert L Satcher
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00544
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0966
Identifier Type: OTHER
Identifier Source: secondary_id
2015-00051255-Y1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2015-0966
Identifier Type: -
Identifier Source: org_study_id
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