Bone Metastases, Cancer Survivor, Metastatic Malignant Neoplasm in the Bone
Conditions
Keywords
Bone metastases, Intramedullary nailing surgery, IM, Physical tasks, Surveys, Questionnaires, Smartphone, Tablet, Telemedicine, Telemonitoring
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.
Interventions
OTHERMonitoring Device
Undergo surgical wound and physical activity monitoring
Undergo physical activity measurement
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREStandard Follow-Up Care
Undergo standard follow-up care
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Rater Agreement on the Physician Assessed Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Follow-Up Assessments | Up to 25 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase I (Standard Follow up, Physical Activity Measurement) 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.
Physical Activity Measurement: Undergo physical activity measurement
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Standard Follow-Up Care: Undergo standard follow-up care
Survey Administration: Ancillary studies | 18 |
| Phase 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.
Monitoring Device: Undergo surgical wound and physical activity monitoring
Physical Activity Measurement: Undergo physical activity measurement
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Standard Follow-Up Care: Undergo standard follow-up care
Survey Administration: Ancillary studies | 52 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 5 |
| Overall Study | Non- Compliant | 0 | 40 |
| Overall Study | Software Issues | 12 | 7 |
Baseline characteristics
| Characteristic | Phase II (Mobile Surveillance) | Total | Phase I (Standard Follow up, Physical Activity Measurement) |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 52 participants | 70 participants | 18 participants |
| Sex: Female, Male Female | 30 Participants | 40 Participants | 10 Participants |
| Sex: Female, Male Male | 22 Participants | 30 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 18 | 5 / 52 |
| other Total, other adverse events | 0 / 18 | 0 / 52 |
| serious Total, serious adverse events | 0 / 18 | 0 / 52 |
Outcome results
Primary
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
Population: Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.
Secondary
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
Population: Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.