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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic
NOT_YET_RECRUITING
Phoenix
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Other Locations
Canada
Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary
RECRUITING
Calgary
Mount Sinai Hospital, University of Toronto
NOT_YET_RECRUITING
Toronto
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 800
Treatments
Sarcoma
Adult patients treated with surgery for bone and soft tissue sarcoma, and giant cell tumor of bone
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, University of Toronto
Leads: University of Calgary

This content was sourced from clinicaltrials.gov