RecruitingNCT07227961

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

Sponsor

University of Calgary

Enrollment

800 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Sarcoma Giant Cell Tumor of Bone

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks health outcomes and quality of life in people with bone or soft tissue sarcoma (cancer of the bones or connective tissues) who are undergoing surgery. Participants complete questionnaires through a smartphone app before and after surgery. **You may be eligible if...** - You are 18 or older with a diagnosis of bone sarcoma, soft tissue sarcoma, or giant cell tumor of bone - Your tumor is in the pelvis, arms, or legs - You are scheduled for surgery to remove the tumor (including limb-sparing or amputation) - You have an iPhone or Android smartphone - You speak English **You may NOT be eligible if...** - Your tumor is a metastatic bone tumor (cancer that has spread to bone from elsewhere) - You have been diagnosed with atypical lipomatous tumor or dermatofibrosarcoma protuberans (less aggressive tumor types) - You are pregnant or plan to become pregnant within 6 months - You have difficulty completing questionnaires due to cognitive or communication barriers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgery

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

Locations(4)

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

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NCT07227961

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