PROMIS and Mobility Evaluation in Sarcoma Patients
Evaluating the Implementation, Utility, and Clinical Importance of the Patient-Reported Outcome Measure Information System (PROMIS) in Sarcoma Patients: A Multi-Centered Prospective Cohort Study
University of Calgary
800 participants
Jul 1, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- Age ≥ 18 years
- Diagnosis of bone sarcoma, soft tissue sarcoma, or giant cell tumor of bone
- Tumors located in the pelvis, lower extremities, or upper extremities
- Primary or recurrent disease
- Undergoing operative tumor resection, including limb salvage surgery and amputation
- Has an iPhone or Android phone
- Speaks English
Exclusion Criteria5
- Metastatic bone tumor
- Diagnosis of atypical lipomatous tumor or dermatofibrosarcoma protuberans
- Currently pregnant or planning pregnancy within 6 months
- Unwilling or unable to attend follow-up evaluations
- Cognitive or communication barriers that impede completion of questionnaires
Interventions
Any type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07227961