- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02715856
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have been scheduled for an intramedullary nailing (IM) surgery with the department of Orthopaedic Oncology at University of Texas (UT) MD Anderson Cancer Center
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Ancillary studies
Undergo standard follow-up care
Undergo physical activity measurement
Other Names:
|
Experimental: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Ancillary studies
Undergo standard follow-up care
Undergo physical activity measurement
Other Names:
Undergo surgical wound and physical activity monitoring
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-Rater Agreement on the Physician Assessed Score
Time Frame: 7 months
|
Inter-rater agreement on the physician assessed score defined as less than 10% difference between the Musculoskeletal Tumor Society (MSTS) scores evaluated using video vs. face-to-face follow ups.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of Follow-Up Assessments
Time Frame: Up to 25 weeks
|
Participant considered having completed the follow-up assessments if the three outcomes are documented for the 2-, 6-, 12, and 24-week evaluations.
Follow-up assessment information taken from Musculoskeletal Tumor Society Scores (MSTS), Timed "Up and Go" test (TUG), and Patient Reported Outcomes Measurement Information System (PROMIS).
|
Up to 25 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert L Satcher, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0966 (Other Identifier: M D Anderson Cancer Center)
- NCI-2016-00544 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 2015-00051255-Y1 (Other Grant/Funding Number: Cancer Survivorship Research Seed Money Grant)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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