PROMIS questionnaires and smartphone mobility tracking after sarcoma surgery
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
This project tests whether PROMIS questionnaires together with a new smartphone app can track recovery and mobility in adults undergoing surgery for sarcoma or giant cell tumor of bone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Trial ID | NCT07227961 on ClinicalTrials.gov |
What this trial studies
Adults with bone or soft-tissue sarcoma or giant cell tumor of bone who are scheduled for tumor resection will use a smartphone app to complete PROMIS questionnaires before surgery and at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. The app will also passively collect mobility metrics such as daily step count, stairs climbed, and gait parameters. Researchers will compare PROMIS scores to the passive mobility data to validate PROMIS in this population and to characterize recovery trajectories following different surgical approaches. Enrollment is limited to English-speaking adults with an iPhone or Android device and excludes patients with metastatic bone tumors or certain tumor types, and the project is observational and conducted at centers in Calgary and at Mayo Clinic sites.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults (≥18) with primary or recurrent bone or soft-tissue sarcoma or giant cell tumor located in the pelvis or limbs who are scheduled for operative tumor resection and own a smartphone.
Not a fit: Patients with metastatic bone disease, certain excluded tumor types (atypical lipomatous tumor or dermatofibrosarcoma protuberans), those who are pregnant, lack a smartphone, or cannot complete questionnaires are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could offer more precise, patient-centered measures of functional recovery and allow remote monitoring of mobility after sarcoma surgery.
How similar studies have performed: PROMIS has been validated in orthopedic and oncology populations, but its performance specifically in orthopaedic oncology is not well established, and using passive smartphone mobility data in this context is a relatively novel approach with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 3 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Not_yet_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary — Calgary, Alberta, Canada (Recruiting)
- Mount Sinai Hospital, University of Toronto — Toronto, Ontario, Canada (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.