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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monitoring Device
Physical Activity Measurement
Quality-of-Life Assessment
Questionnaire Administration
Standard Follow-Up Care
Survey Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bone Metastases focused on measuring Bone metastases, Intramedullary nailing surgery, IM, Physical tasks, Surveys, Questionnaires, Smartphone, Tablet, Telemedicine, Telemonitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (standard follow up, physical activity measurement)

Group II (mobile surveillance)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
March 17, 2016
Last Updated
October 10, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02715856
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to software issues and depletion of funds the protocol was terminated early
Study Start Date
April 13, 2016 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (standard follow up, physical activity measurement)
Arm Type
Active Comparator
Arm 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.
Arm Title
Group II (mobile surveillance)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Monitoring Device
Other Intervention Name(s)
Monitor
Intervention Description
Undergo surgical wound and physical activity monitoring
Intervention Type
Other
Intervention Name(s)
Physical Activity Measurement
Other Intervention Name(s)
Activity
Intervention Description
Undergo physical activity measurement
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Standard Follow-Up Care
Intervention Description
Undergo standard follow-up care
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Inter-Rater Agreement on the Physician Assessed Score
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Completion of Follow-Up Assessments
Description
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).
Time Frame
Up to 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Satcher
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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