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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:April 2016
End Date:April 2019
Contact:Robert L. Satcher, MD, PHD
Phone:713-745-4117

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

This is an investigational study.

Up to 60 participants will be enrolled in this study. Up to 12 clinicians will also take part
in this study. All will take part at MD Anderson.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. You 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 you are assigned
to Group 2, you 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, you will have standard follow-up visits. You will
not have any visits or procedures that are specific to this study. However, you will complete
questionnaires that are specific to this study.

You 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, you will be asked to walk a certain distance (about
30 feet) while a physical therapist watches your steps. You will be asked to walk around the
room in certain ways, and step over lines on the floor. You will also fill out a survey about
your physical and emotional health as well as your pain. At the end of the study, you 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, you
will be asked to fill out a questionnaire about the study.

Visits for Group 2:

At a scheduled clinic visit before your surgery, you will be taught how to take photos of
your surgical wounds and make videos using a mobile device.

About 2, 6,12, and 24 weeks after surgery, you will have standard follow-up visits which will
include the same surveys and physical therapy measures described above. However, at Weeks 3,
7, 13, and 25 you will use a mobile device to send the study staff photos of your surgical
wound and video of you walking. These updates will help your doctor to check your recovery.
The photos you will take will only be of a small area of skin near your wound.

For the videos, you will need a family member or friend to hold the mobile device camera and
record video of you as you walk 10 feet away from the camera and then walk back toward the
camera. You will also repeat this with the camera viewing from the side as you walk 10 feet
back and forth.

At the end of each follow-up visit, you will complete an electronic questionnaire about your
quality of life. This should take about 10 minutes.

In addition, your doctor will have a video conference at Weeks 3, 7, 13, and 25. At any time
the doctor thinks it is needed, you will also have a video conference with your doctor. You
will be asked basic follow-up information about your wound and overall health questions. This
should take about 5-10 minutes.

You will return the mobile device after completion of your 25-week follow up visit using the
mobile device.

Length of Study:

If you are in Group 1, your participation in this study will be over after the 24-week
follow-up has been completed. If you are in Group 2, your participation will be over after
the 25-week follow-up has been completed.

Your study participation may end early if you are unable to follow study directions.

Inclusion Criteria:

1. have been scheduled for an Intramedullary nailing (IM) surgery with the department of
Orthopaedic Oncology at UT MD Anderson Cancer Center.

2. Are able to read and write English

3. Are 18 years or older

4. Are willing and able to use a smartphone or tablet comfortably

5. Have access to mobile hot spot, wireless internet, and/or cellular service

6. Must have a caregiver or assistance at home who can assist with collecting PT
measures.

Exclusion:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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