Recruiting

PROMIS Validation

Sponsor:

University of Calgary

Code:

NCT07227961

Conditions

Sarcoma

Giant Cell Tumor of Bone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgery

Study Details

Brief summary:

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.

Conditions

Sarcoma

Giant Cell Tumor of Bone

Study ID

NCT07227961

Start date

Jul 1, 2025

Status verified date

Oct, 2025

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Sarcoma

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

Interventions

Surgery

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

Primary outcome measure

  • Step count [ Time Frame: From enrolment to one year post-operative ]
  • Distance travelled [ Time Frame: From enrolment to 1 year post-operative ]
  • Flights of stairs climbed [ Time Frame: From enrolment to 1 year post-operative ]
  • Gait asymmetry [ Time Frame: From enrolment to 1 year post-operative ]
  • Distinct activity periods [ Time Frame: From enrolment to 1 year post-operative ]
  • Total time active [ Time Frame: From enrolment to 1 year post-operative ]
  • PROMIS Global Health [ Time Frame: From enrolment to 1 year post-operative ]
  • PROMIS Self Efficacy [ Time Frame: From enrolment to 1 year post-operative ]
  • PROMIS Pain Interference [ Time Frame: From enrolment to 1 year post-operative ]
  • PROMIS Physical Function [ Time Frame: From enrolment to 1 year post-operative ]
  • PROMIS Upper Extremity Function [ Time Frame: From enrolment to 1 year post-operative ]
  • Toronto Extremity Salvage Score Lower Extremity [ Time Frame: From enrolment to 1 year post-operative ]
  • Toronto Extremity Salvage Score Upper Extremity [ Time Frame: From enrolment to 1 year post-operative ]
  • Maximal oxygen consumption (VO2 max) [ Time Frame: From enrolment to 1 year post-operative ]
  • Heart rate [ Time Frame: From enrolment to 1 year post-operative ]
  • Heart rate variability [ Time Frame: From enrolment to 1 year post-operative ]

Central Contacts and Locations

Locations

Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Joseph K Kendal, MD MSc FRCSC

403-944-4793jkkendal@ucalgary.ca

Alyssa A Federico, MD

403-650-5071alyssa.federico@ucalgary.ca

Principal Investigator:

Joseph K Kendal, MD MSc FRCSC

More Information

Sponsor

University of Calgary

Last update posted

Nov 13, 2025

Last verified

Oct, 2025

Keywords

  • Patient reported outcomes
  • PROMIS
  • TESS
  • Mobility
  • Recovery
  • Surgery
  • App
  • Digital health
  • Sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-11-13.