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

Not Applicable

Terminated

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

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

Registration Number: NCT02715856

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 70

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (standard follow up, physical activity measurement)	Quality-of-Life Assessment	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 I (standard follow up, physical activity measurement)	Questionnaire Administration	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)	Quality-of-Life Assessment	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.
Group II (mobile surveillance)	Monitoring Device	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.
Group II (mobile surveillance)	Survey Administration	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.
Group I (standard follow up, physical activity measurement)	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.
Group I (standard follow up, physical activity measurement)	Survey Administration	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)	Physical Activity Measurement	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.
Group II (mobile surveillance)	Questionnaire Administration	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.
Group II (mobile surveillance)	Standard Follow-Up Care	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.
Group I (standard follow up, physical activity measurement)	Standard Follow-Up Care	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.

Primary Outcome Measures

Name	Time	Method
Inter-Rater Agreement on the Physician Assessed Score	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.

Secondary Outcome Measures

Name	Time	Method
Completion of Follow-Up Assessments	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).