Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases

Study Overview
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Brief Summary
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This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. The use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.

Detailed Description
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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.

Official Title
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Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function

Conditions
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Bone Metastases, Cancer Survivor, Metastatic Malignant Neoplasm in the Bone

Intervention / Treatment
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* Other: Monitoring Device
* Other: Physical Activity Measurement
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Standard Follow-Up Care
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention 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)<br>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. | Other: Physical Activity Measurement<br>* Undergo physical activity measurement<br>* Other names: Activity;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Standard Follow-Up Care<br>* Undergo standard follow-up care<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Group II (mobile surveillance)<br>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. | Other: Monitoring Device<br>* Undergo surgical wound and physical activity monitoring<br>* Other names: Monitor;Other: Physical Activity Measurement<br>* Undergo physical activity measurement<br>* Other names: Activity;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Standard Follow-Up Care<br>* Undergo standard follow-up care<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Rater Agreement on the Physician Assessed Score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone metastases, Intramedullary nailing surgery, IM, Physical tasks, Surveys, Questionnaires, Smartphone, Tablet, Telemedicine, Telemonitoring