Clinical Trial: Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function

Brief Summary: The goal of this study is to learn about performing follow-up care using mobile devices (smartphones or tablet computers) after surgery.

Detailed Summary:

Study Groups:

If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Participant will have an equal (50/50) chance of being assigned to either group.

Both Group 1 and Group 2 will have standard, face-to-face follow-up visits. Group 1 will be the control group and will have no mobile device intervention. However, if participant is assigned to Group 2, they will also be asked to record videos between follow-up visits and send them to the study staff. The study staff will provide the mobile device for recording the videos.

Visits for Group 1 (Control Group):

About 2, 6, 12, and 24 weeks after surgery, participant will have standard follow-up visits. Participant will not have any visits or procedures that are specific to this study. However, participant will complete questionnaires that are specific to this study.

Participant will be asked to sit in a chair, stand, walk about 10 feet, turn around, return to the chair, and sit down. During another test, participant will be asked to walk a certain distance (about 30 feet) while a physical therapist watches their steps. Participant will be asked to walk around the room in certain ways, and step over lines on the floor. Participant will also fill out a survey about their physical and emotional health as well as their pain. At the end of the study, participant will be asked to fill out another questionnaire regarding the study. Both the physical tests and the surveys should take about 15 minutes to complete. In addition, at the end of the study, participant will be asked to fill out a questionnaire about the study.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Inter-Rater Agreement on the Physician Assessed Score [ Time Frame: 7 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Completion of Follow-Up Assessments [ Time Frame: 7 months ]

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).


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: March 17, 2016
Date Started: April 2016
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016