PROMIS and Mobility Evaluation in Sarcoma Patients

NCT07227961 | Recruiting

• 1 other identifier: HREBA.CC-25-0017
• Study Type: observational
• Target: 800
• Locations: 2 countries
• Sites: 4

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. 1.Validate PROMIS as a patient outcome measure in sarcoma
2. 2.Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics
3. 3.Compare PROMIS scores and mobility metrics to better evaluate recovery trajectories after surgery

Conditions

Sarcoma; Giant Cell Tumor of Bone

Keywords

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

Outcome Measures

Primary Outcomes (16)

• Step count

  Number of steps

  From enrolment to one year post-operative

• Distance travelled

  Kilometers

  From enrolment to 1 year post-operative

• Flights of stairs climbed

  Number of flights climbed

  From enrolment to 1 year post-operative

• Gait asymmetry

  Percentage

  From enrolment to 1 year post-operative

• Distinct activity periods

  Number of distinct activity periods \>10 minutes

  From enrolment to 1 year post-operative

• Total time active

  Minutes

  From enrolment to 1 year post-operative

• PROMIS Global Health

  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.

  From enrolment to 1 year post-operative

• PROMIS Self Efficacy

  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.

  From enrolment to 1 year post-operative

• PROMIS Pain Interference

  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.

  From enrolment to 1 year post-operative

• PROMIS Physical Function

  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.

  From enrolment to 1 year post-operative

• PROMIS Upper Extremity Function

  Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.

  From enrolment to 1 year post-operative

• Toronto Extremity Salvage Score Lower Extremity

  Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.

  From enrolment to 1 year post-operative

• Toronto Extremity Salvage Score Upper Extremity

  Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.

  From enrolment to 1 year post-operative

• Maximal oxygen consumption (VO2 max)

  Litres per minute. A higher VO2 max indicates that the body is more efficient at using oxygen to produce energy in the muscles.

  From enrolment to 1 year post-operative

• Heart rate

  Beats per minute

  From enrolment to 1 year post-operative

• Heart rate variability

  Milliseconds. Measures the variation in time between each beat of your heart, with a higher score generally indicating better physical fitness.

  From enrolment to 1 year post-operative

Secondary Outcomes (1)

• App Survey

  Single collection time point at 1 year post-operative.

Study Arms (1)

Sarcoma

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

Procedure: Surgery

Interventions

Surgery PROCEDURE

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

Also known as: Operation, Procedure, Tumor resection, Amputation, Bone stabilization

Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• University of Toronto: collaborator
• Mayo Clinic: collaborator

Study Sites (4)

Mayo Clinic

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

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

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, M5G 1X5, Canada

NOT YET RECRUITING

Related Publications (13)

• Tyser AR, Beckmann J, Franklin JD, Cheng C, Hon SD, Wang A, Hung M. Evaluation of the PROMIS physical function computer adaptive test in the upper extremity. J Hand Surg Am. 2014 Oct;39(10):2047-2051.e4. doi: 10.1016/j.jhsa.2014.06.130. Epub 2014 Aug 16.

  PMID: 25135249 BACKGROUND

• Hung M, Stuart AR, Higgins TF, Saltzman CL, Kubiak EN. Computerized Adaptive Testing Using the PROMIS Physical Function Item Bank Reduces Test Burden With Less Ceiling Effects Compared With the Short Musculoskeletal Function Assessment in Orthopaedic Trauma Patients. J Orthop Trauma. 2014 Aug;28(8):439-43. doi: 10.1097/BOT.0000000000000059.

  PMID: 24378399 BACKGROUND

• Jensen RE, Potosky AL, Reeve BB, Hahn E, Cella D, Fries J, Smith AW, Keegan TH, Wu XC, Paddock L, Moinpour CM. Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients. Qual Life Res. 2015 Oct;24(10):2333-44. doi: 10.1007/s11136-015-0992-9. Epub 2015 May 3.

  PMID: 25935353 BACKGROUND

• Blank AT, Lerman DM, Shaw S, Dadrass F, Zhang Y, Liu W, Hung M, Jones KB, Randall RL. PROMIS(R) scores in operative metastatic bone disease patients: A multicenter, prospective study. J Surg Oncol. 2018 Sep;118(3):532-535. doi: 10.1002/jso.25159. Epub 2018 Aug 16.

  PMID: 30114336 BACKGROUND

• Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341.

  PMID: 17991929 BACKGROUND

• Ploetze KL, Dalton JF, Calfee RP, McDonald DJ, O'Keefe RJ, Cipriano CA. Patient-Reported Outcomes Measurement Information System physical function correlates with Toronto Extremity Salvage Score in an orthopaedic oncology population. J Orthop Translat. 2019 Mar 8;19:143-150. doi: 10.1016/j.jot.2019.02.004. eCollection 2019 Oct.

  PMID: 31844622 BACKGROUND

• Ogura K, Uehara K, Akiyama T, Shinoda Y, Iwata S, Tsukushi S, Kobayashi E, Hirose T, Yonemoto T, Endo M, Tanzawa Y, Nakatani F, Kawano H, Tanaka S, Kawai A. Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma. J Orthop Sci. 2020 Mar;25(2):315-318. doi: 10.1016/j.jos.2019.03.022. Epub 2019 Apr 16.

  PMID: 31000377 BACKGROUND

• Hassani M, Mate KKV, Turcotte R, Denis-Larocque G, Ghodsi E, Tsimicalis A, Goulding K. Uncovering the gaps: A systematic mixed studies review of quality of life measures in extremity soft tissue sarcoma. J Surg Oncol. 2023 Sep;128(3):430-437. doi: 10.1002/jso.27390.

  PMID: 37537979 BACKGROUND

• Vijayakumar G, Blank AT. Patient-reported outcome tools in musculoskeletal oncology. J Surg Oncol. 2023 Sep;128(3):418-424. doi: 10.1002/jso.27386.

  PMID: 37537983 BACKGROUND

• Goulding KA, Wilke BK, Kiernan HC, Houdek MT, Sherman CE. Skeletal Sarcomas: Diagnosis, Treatment, and Follow-up from the Orthopedic Oncologist Perspective. Radiol Clin North Am. 2022 Mar;60(2):193-203. doi: 10.1016/j.rcl.2021.11.001.

  PMID: 35236588 BACKGROUND

• Gutowski CJ, Basu-Mallick A, Abraham JA. Management of Bone Sarcoma. Surg Clin North Am. 2016 Oct;96(5):1077-106. doi: 10.1016/j.suc.2016.06.002.

  PMID: 27542644 BACKGROUND

• Walczak BE, Irwin RB. Sarcoma chemotherapy. J Am Acad Orthop Surg. 2013 Aug;21(8):480-91. doi: 10.5435/JAAOS-21-08-480.

  PMID: 23908254 BACKGROUND

• Burningham Z, Hashibe M, Spector L, Schiffman JD. The epidemiology of sarcoma. Clin Sarcoma Res. 2012 Oct 4;2(1):14. doi: 10.1186/2045-3329-2-14.

  PMID: 23036164 BACKGROUND

MeSH Terms

Conditions

Sarcoma; Giant Cell Tumor of Bone; Alzheimer Disease

Interventions

Surgical Procedures, Operative; Methods; Transurethral Resection of Bladder; Amputation, Surgical

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Bone Tissue; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Urologic Surgical Procedures; Urogenital Surgical Procedures; Orthopedic Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (2)