Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-28 @ 3:59 PM
Study NCT ID:
NCT02715856
Status:
TERMINATED
Last Update Posted:
2022-10-13
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to software issues and depletion of funds the protocol was terminated early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: