PROMIS and Mobility Evaluation in Sarcoma Patients

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Calgary
Study ID
NCT07227961
Status
Recruiting
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Conditions

  • Giant Cell Tumor of Bone
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Sarcoma
    Adult patients treated with surgery for bone and soft tissue sarcoma, and giant cell tumor of bone

Primary Outcome Measure

Step count [ Time Frame: From enrolment to one year post-operative ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Krista A Goulding, MD MPH
[email protected]
480-342-2407
Ray Canez, BS
[email protected]
480-574-2753
Krista A Goulding, MD MPH (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Matthew T Houdek, MD
[email protected]
507-284-2995
Matthew T Houdek, MD (PRINCIPAL_INVESTIGATOR)

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