Clinical trial NCT02715856: Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
Official title: Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Metastases
Cancer Survivor
Metastatic Malignant Neoplasm in the Bone
Keywords: Bone metastases
Intramedullary nailing surgery
IM
Physical tasks
Surveys
Questionnaires
Smartphone
Tablet
Telemedicine
Telemonitoring
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Inter-Rater Agreement on the Physician Assessed Score
timeFrame: 7 months
Secondary outcomes:
measure: Completion of Follow-Up Assessments
timeFrame: Up to 25 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert L Satcher
role: PRINCIPAL_INVESTIGATOR
References: