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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Monitoring Device	Undergo surgical wound and physical activity monitoring
OTHER	Physical Activity Measurement	Undergo physical activity measurement
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Standard Follow-Up Care	Undergo standard follow-up care
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2016-04-13
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2016-03-22
• Last updated: 2022-10-13
• Results posted: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study