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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Giant Cell Tumor of Bone
• Intervention / Treatment: Procedure: Surgery

Detailed Description

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 item response theory in a standardized manner for precise and sensitive measures. PROMIS was developed with oncology research considerations and has been validated in both orthopaedic and oncology populations. However, the significance of PROMIS in orthopaedic oncology is not well understood.

Assessing patient reported outcomes is limited by survey completion rates, particularly in the oncology patients who have multiple medical appointments and care teams. To address these challenges, our team has developed ACTIVATION (Activity Capture To Investigate Voluntary ActiviTy In Orthopaedic populatioNs), a smartphone application (app) tailored to musculoskeletal oncology. Unlike general fitness or commercial health applications, ACTIVATION passively captures mobility metrics and remotely administers PROMIS questionnaires. The continuous data collection aligns real-world mobility with clinical recovery timelines, offering a more precise view of patient outcomes.

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.

Hypothesis:

PROMIS and mobility metrics will provide a holistic and granular view of recovery trajectories, and the use of a novel smartphone application will improve patient engagement and data collection.

Aims:

1. Compare PROMIS to the current gold standard, the Toronto Extremity Salvage Score (TESS), in sarcoma
2. Determine the minimal clinically important difference (MCID) for PROMIS in sarcoma
3. Assess the feasibility and usability of an novel app for remote PROMIS and TESS administration, and mobility data collection
4. Correlate PROMIS and TESS scores with mobility metrics to define recovery trajectories
5. Identify demographic and socioeconomic factors that influence app engagement

Methods:

Recruitment and Sample Size: The investigator will recruit all eligible subjects identified by musculoskeletal oncology surgeons at the four study sites. The investigators anticipates enrolling approximately 800 sarcoma patients based on current surgical volumes and patient capture rates for collecting quality of life and functional data.

Data Collection:

Patients will be asked to download the ACTIVATION app on their smartphone and complete a demographic intake form. Clinical data will be obtained through the local electronic medical record. The TESS and PROMIS global health, self-efficacy, physical function, upper extremity function, and pain interference questionnaires will completed through the ACTIVATION app. Completion of these forms will be prompted via push notifications pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operative. Additionally, the app will passively collect mobility metrics from the smartphone operating system including step count, distance travelled, flights climbed, gait asymmetry, distinct activity periods (>10 minutes), and total time active. In patients who have a compatible smart watch, the investigators will also collect physiologic parameters including VO2 max, heart rate, and heart rate variability. At the end of study participation, two additional surveys will be administered. The survey will collect feedback about the overall efficacy of the app and assess participant phone carrying habits.

Statistical Analysis:

Longitudinal changes in PROMIS scores will be analyzed using linear mixed-effects models with time and patient-level covariates (e.g. age, sex, race, socioeconomic status) as fixed effects and patient as a random effect. Logistic regression will identify predictors of PROMIS completion. MCIDs for PROMIS domains will be calculated using an anchor-based method with the Global Rating of Change. The sensitivity of PROMIS will be compared to TESS using correlation coefficients, Bland-Altman plots, and linear regression models.

Mobility data will undergo principal component analysis to derive a composite index capturing the key features of interest. ROC curves will assess whether mobility changes predict meaningful changes in PROMIS scores. Additionally, subgroup analysis will be performed to determine if differences in recovery exist based on tumor location, type of surgery, and adjuvant cancer therapies. Missing data will be evaluated for randomness and addressed using multiple imputation or maximum likelihood estimation as appropriate.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary
      • Contact: Joseph K Kendal, MD MSc FRCSC; Phone Number: 403-944-4793; Email: jkkendal@ucalgary.ca
      • Contact: Alyssa A Federico, MD; Phone Number: 403-650-5071; Email: alyssa.federico@ucalgary.ca
      • Principal Investigator: Joseph K Kendal, MD MSc FRCSC
      • Sub-Investigator: Michael J Monument, MD MSc FRCSC
      • Sub-Investigator: Shannon Puloski, MD FRCSC
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Not yet recruiting
      • Mount Sinai Hospital, University of Toronto
      • Contact: Jay S Wunder, MD MSc FRCSC; Phone Number: 8807 416-586-4800; Email: jay.wunder@sinaihealth.ca
      • Contact: Anthony Griffin, MSc; Phone Number: 5975 416-586-4800; Email: anthony.griffin@sinaihealth.ca
      • Principal Investigator: Jay S Wunder, MD MSc FRCSC
      • Sub-Investigator: Peter C Ferguson, MD MSc FRCSC FAOA
      • Sub-Investigator: Aaron M Gazendam, MD MSc FRCSC
      • Sub-Investigator: Kim Tsoi, MD PhD FRCSC
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Krista A Goulding, MD MPH; Phone Number: 480-342-2407; Email: goulding.krista@mayo.edu
      • Contact: Ray Canez, BS; Phone Number: 480-574-2753; Email: Canez.Lupe@mayo.edu
      • Principal Investigator: Krista A Goulding, MD MPH
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Matthew T Houdek, MD; Phone Number: 507-284-2995; Email: houdek.matthew@mayo.edu
      • Principal Investigator: Matthew T Houdek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sarcoma; Adult patients treated with surgery for bone and soft tissue sarcoma, and giant cell tumor of bone	Procedure: Surgery; Any type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization.; Other Names: Operation; Tumor resection; Amputation; Procedure; Bone stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	Single collection time point at 1 year post-operative.

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Mayo Clinic; University of Toronto

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 10, 2025
• First Posted (Estimated): November 13, 2025

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Recovery; Surgery; App; Mobility; Sarcoma; TESS; Digital health; PROMIS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms; Neoplasms by Histologic Type; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Giant Cell Tumors; Alzheimer Disease; Sarcoma; Giant Cell Tumor of Bone; Investigative Techniques; Urologic Surgical Procedures; Urogenital Surgical Procedures; Orthopedic Procedures; Methods; Surgical Procedures, Operative; Transurethral Resection of Bladder; Amputation, Surgical
• Other Study ID Numbers: HREBA.CC-25-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participant privacy and confidentiality, the investigators will not share IPD with other researchers. The study involves sensitive or identifiable health information and the consent obtained from participants does not include permission to share their individual-level data publicly or with third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No