NCT07227961 PROMIS and Mobility Evaluation in Sarcoma Patients
| NCT ID | NCT07227961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Sarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-07-01 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT07227961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227961 currently recruiting?
Yes, NCT07227961 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Calgary to inquire about joining.
Where is the NCT07227961 trial being conducted?
This trial is being conducted at Phoenix, United States, Rochester, United States, Calgary, Canada, Toronto, Canada.
Who is sponsoring the NCT07227961 clinical trial?
NCT07227961 is sponsored by University of Calgary. The trial plans to enroll 800 participants.