Trial Outcomes & Findings for Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases (NCT NCT02715856)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

7 months

Results posted on

2022-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 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. 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	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
Overall Study STARTED	18	52
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	18	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 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. 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	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
Overall Study Software Issues	12	7
Overall Study Death	6	5
Overall Study Non- Compliant	0	40

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I (Standard Follow up, Physical Activity Measurement) n=18 Participants 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	Phase II (Mobile Surveillance) n=52 Participants 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	Total n=70 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 9 • n=18 Participants	59 years STANDARD_DEVIATION 13 • n=52 Participants	61 years STANDARD_DEVIATION 12 • n=70 Participants
Sex: Female, Male Female	10 Participants n=18 Participants	30 Participants n=52 Participants	40 Participants n=70 Participants
Sex: Female, Male Male	8 Participants n=18 Participants	22 Participants n=52 Participants	30 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	52 participants n=52 Participants	70 participants n=70 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome data not reported

Adverse Events

Phase I (Standard Follow up, Physical Activity Measurement)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Phase II (Mobile Surveillance)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology

UT MD Anderson Cancer Center

Phone: (713) 794-5242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place