PROMIS and Mobility Evaluation in Sarcoma Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgery

Treatment groups

800 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Calgary

Lead sponsor

University of Toronto

Collaborator

Mayo Clinic

Collaborator