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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02715856
• Other study ID #: 2015-0966
• Secondary ID: NCI-2016-0054420
• Status: Terminated
• Phase: N/A
• Start date: April 13, 2016
• Est. completion date: September 28, 2021

Study information

• Verified date: October 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Cancer Survivor
• Metastatic Malignant Neoplasm in the Bone
• Neoplasm Metastasis
• Neoplasms

Intervention

Other:
• 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

Procedure:
• Standard Follow-Up Care
Undergo standard follow-up care

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   MD Anderson Cancer Center Website