Back to Clinical Trials
N/ARecruiting

PROMIS and Mobility Evaluation in Sarcoma Patients

Sponsored by University of Calgary

About this study

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.

Background \& Rationale: Sarcoma is a rare form of bone and soft tissue cancer, making up about 1% of all adult cancers. Management typically involves radiation therapy, chemotherapy, and surgical resection, with or without limb reconstruction. The diagnosis, intensive treatment regimen, and surgery-induced deficits significantly impact patient quality of life and function. Evaluating outcomes in sarcoma is challenging due to disease heterogeneity, complexity, and variation in surgical strategy. Patient-reported outcomes measures are crucial for evaluating treatment outcomes and facilitating patient-centered care. Traditional validated PROMs, like the Toronto Extremity Salvage Score (TESS), have significant ceiling effects. PROMIS assesses physical, mental, and social well-being using it…

Where this study is enrolling (2)

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.