An interventional study of Monitoring Device and Physical Activity Measurement in Bone Metastases, Cancer Survivor and Metastatic Malignant Neoplasm in the Bone, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Health services research
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.
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.
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This study's enrollment of 70 is above the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.
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Exclusion:
N/A
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.
Other: Physical Activity Measurement · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Standard Follow-Up Care · Other: Survey Administration
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.
Other: Monitoring Device · Other: Physical Activity Measurement · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Standard Follow-Up Care · Other: Survey Administration
Undergo surgical wound and physical activity monitoring
Also known as: Monitor
Undergo physical activity measurement
Also known as: Activity
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo standard follow-up care
Ancillary studies
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.
Time frame: 7 months
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).
Time frame: Up to 25 weeks
| Milestone | Phase I (Control) | Phase II (Mobile Surveillance) |
|---|---|---|
| Started | 18 | 52 |
| Completed | 0 | 0 |
| Not completed | 18 | 52 |
| Withdrew: Software issues | 12 | 7 |
| Withdrew: Death | 6 | 5 |
| Withdrew: Non- compliant | 0 | 40 |
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
Collected over 3 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I (Standard Follow up, Physical Activity Measurement) | 6/18 (33.3%) | 0/18 (0%) | 0/18 (0%) |
| Phase II (Mobile Surveillance) | 5/52 (9.6%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Phase I (Standard Follow up, Physical Activity Measurement) | Phase II (Mobile Surveillance) | Total |
|---|---|---|---|
| Mean | 66 ± 9 | 59 ± 13 | 61 ± 12 |
| Sex: Female, Male(Participants) | Phase I (Standard Follow up, Physical Activity Measurement) | Phase II (Mobile Surveillance) | Total |
|---|---|---|---|
| Female | 10 | 30 | 40 |
| Male | 8 | 22 | 30 |
| Race and Ethnicity Not Collected(Participants) | Phase I (Standard Follow up, Physical Activity Measurement) | Phase II (Mobile Surveillance) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Phase I (Standard Follow up, Physical Activity Measurement) | Phase II (Mobile Surveillance) | Total |
|---|---|---|---|
| United States | 18 | 52 | 70 |
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M.D. Anderson Cancer Center