PROMIS and Mobility Evaluation in Sarcoma Patients
Recruiting · NCT07227961 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Calgary
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
4 locations listed across 2 US states.
- Mayo Clinic - Phoenix, Arizona, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary - Calgary, Alberta, Canada
- Mount Sinai Hospital, University of Toronto - Toronto, Ontario, Canada