PROMIS and Mobility Evaluation in Sarcoma Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Surgery: Any type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization.

Study summary

The goal of this is to validate the Patient-Reported Outcomes Measurement Information System (PROMIS) in sarcoma patients undergoing surgery, and to evaluate a novel smartphone app for collecting mobility data. The goals of the study include to:

1. Validate PROMIS as a patient outcome measure in sarcoma
2. Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics
3. Compare PROMIS scores and mobility metrics to better evaluate recovery trajectories after surgery

Participants will complete PROMIS questionnaires at regularly scheduled intervals using the smartphone app. Questionnaires will be completed pre-operatively and at 6 weeks, 12 weeks, 6 months, and 12 months post-operatively. Additionally, the app will passively track mobility metrics such as daily step count, stairs climbed, and gait parameters to compare with PROMIS scores.

Eligibility

Primary outcome measure(s)

• Step count — From enrolment to one year post-operative
  Number of steps
• Distance travelled — From enrolment to 1 year post-operative
  Kilometers
• Flights of stairs climbed — From enrolment to 1 year post-operative
  Number of flights climbed
• Gait asymmetry — From enrolment to 1 year post-operative
  Percentage
• Distinct activity periods — From enrolment to 1 year post-operative
  Number of distinct activity periods \>10 minutes
• Total time active — From enrolment to 1 year post-operative
  Minutes
• PROMIS Global Health — From enrolment to 1 year post-operative
  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
• PROMIS Self Efficacy — From enrolment to 1 year post-operative
  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
• PROMIS Pain Interference — From enrolment to 1 year post-operative
  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
• PROMIS Physical Function — From enrolment to 1 year post-operative
  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
• PROMIS Upper Extremity Function — From enrolment to 1 year post-operative
  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
• Toronto Extremity Salvage Score Lower Extremity — From enrolment to 1 year post-operative
  Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.
• Toronto Extremity Salvage Score Upper Extremity — From enrolment to 1 year post-operative
  Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.
• Maximal oxygen consumption (VO2 max) — From enrolment to 1 year post-operative
  Litres per minute. A higher VO2 max indicates that the body is more efficient at using oxygen to produce energy in the muscles.
• Heart rate — From enrolment to 1 year post-operative
  Beats per minute
• Heart rate variability — From enrolment to 1 year post-operative
  Milliseconds. Measures the variation in time between each beat of your heart, with a higher score generally indicating better physical fitness.

Trial sites (4)

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