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PROMIS and Mobility Evaluation in Sarcoma Patients

Evaluating the Implementation, Utility, and Clinical Importance of the Patient-Reported Outcome Measure Information System (PROMIS) in Sarcoma Patients: A Multi-Centered Prospective Cohort Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics 3."
  • "Questionnaires will be completed pre-operatively and at 6 weeks, 12 weeks, 6 months, and 12 months post-operatively."
  • "Assessing patient reported outcomes is limited by survey completion rates, particularly in the oncology patients who have multiple medical appointments and care teams."
  • "Unlike general fitness or commercial health applications, ACTIVATION passively captures mobility metrics and remotely administers PROMIS questionnaires."
  • "The overall aim of this study is to validate PROMIS in sarcoma patients undergoing surgery, and to evaluate a novel smartphone app for questionnaire administration and collection of mobility data."
  • "At the end of study participation, two additional surveys will be administered."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (2)

AZ

MN