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

M.D. Anderson Cancer Center

Status: Terminated

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02715856

NCI-2016-00544 (Registry Identifier)

2015-00051255-Y1 (Other Grant/Funding Number)

2015-0966 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Group I (standard follow up, physical activity measurement)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Physical Activity Measurement

Other: Survey Administration

Procedure: Standard Follow-Up Care

Other: Quality-of-Life Assessment

Group II (mobile surveillance)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Physical Activity Measurement

Other: Survey Administration

Procedure: Standard Follow-Up Care

Other: Quality-of-Life Assessment

Other: Monitoring Device