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
This trial does not accept healthy volunteersQualifiers
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 population
The investigators will enrol patients under the care of a musculoskeletal oncology surgeon at Foothills Medical Centre (Calgary, AB, Canada), Mount Sinai Hospital (Toronto, ON, Canada), Mayo Clinic Arizona (Phoenix, AZ, United States), and Mayo Clinic Minnesota (Rochester, MN, United States).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgery
Procedure/SurgeryAny type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Sarcoma1 intervention
Trial outcomes
Primary outcomes
1
Step count
Number of steps
Time frame
From enrolment to one year post-operative2
Distance travelled
Kilometers
Time frame
From enrolment to 1 year post-operative3
Flights of stairs climbed
Number of flights climbed
Time frame
From enrolment to 1 year post-operative4
Gait asymmetry
Percentage
Time frame
From enrolment to 1 year post-operativeSecondary outcomes
1
App Survey
Survey administered at the end of study participation to assess satisfaction and user-friendliness of the ACTIVATION app using Liekert scales. Survey also contains three short answer responses collecting feedback about the app and gathering data on technical difficulties. Last section of the survey contains questions about phone use habits using multiple choice questions..
Time frame
Single collection time point at 1 year post-operative.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov