SarcomaNCT07227961
PROMIS and Mobility Evaluation in Sarcoma Patients
An observational study of Sarcoma and Giant Cell Tumor of Bone, run by University of Calgary at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Giant Cell Tumor of Bone
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jul 2025to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Krista A Goulding, MD MPH, 480-342-2407, goulding.krista@mayo.edu
Ray Canez, BS, 480-574-2753, Canez.Lupe@mayo.edu
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Matthew T Houdek, MD, 507-284-2995, houdek.matthew@mayo.edu
Matthew T Houdek, MD
Canada2 sites, 2 recruiting
- Recruiting
Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary
Calgary, Alberta, T2N 2T9
Joseph K Kendal, MD MSc FRCSC, 403-944-4793, jkkendal@ucalgary.ca
Alyssa A Federico, MD, 403-650-5071, alyssa.federico@ucalgary.ca
- Not yet recruiting
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, M5G 1X5
Jay S Wunder, MD MSc FRCSC, 416-586-4800 ext. 8807, jay.wunder@sinaihealth.ca
Anthony Griffin, MSc, 416-586-4800 ext. 5975, anthony.griffin@sinaihealth.ca
About this study
Official title: 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:
- Validate PROMIS as a patient outcome measure in sarcoma
- Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics
- 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.
Read the 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:
- Compare PROMIS to the current gold standard, the Toronto Extremity Salvage Score (TESS), in sarcoma
- Determine the minimal clinically important difference (MCID) for PROMIS in sarcoma
- Assess the feasibility and usability of an novel app for remote PROMIS and TESS administration, and mobility data collection
- Correlate PROMIS and TESS scores with mobility metrics to define recovery trajectories
- 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.
- Conditions
- Sarcoma, Giant Cell Tumor of Bone
- Being tested
- Surgery
- Keywords
- Patient reported outcomes, PROMIS, TESS, Mobility, Recovery, Surgery, App, Digital health, Sarcoma
- Medical subject headings
- Sarcoma, Giant Cell Tumor of Bone, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Operation, Procedure, Tumor resection, Amputation
Any type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoma | Adult patients treated with surgery for bone and soft tissue sarcoma, and giant cell tumor of bone Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
Number of steps
Measured: From enrolment to one year post-operative
Distance travelled
Kilometers
Measured: From enrolment to 1 year post-operative
Flights of stairs climbed
Number of flights climbed
Measured: From enrolment to 1 year post-operative
Gait asymmetry
Percentage
Measured: From enrolment to 1 year post-operative
Distinct activity periods
Number of distinct activity periods >10 minutes
Measured: From enrolment to 1 year post-operative
Total time active
Minutes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrolment to 1 year post-operative
Heart rate
Beats per minute
Measured: 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.
Measured: From enrolment to 1 year post-operative
Secondary outcomes (1)
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..
Measured: Single collection time point at 1 year post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227961
- Sponsor's protocol ID
- HREBA.CC-25-0017
- Status last verified
- Oct 2025
- First submitted
- 4 Nov 2025
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25135249Hung 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.
PubMed 24378399Jensen 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.
PubMed 25935353Blank 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.
PubMed 30114336Garcia 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.
PubMed 17991929Ploetze 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.
PubMed 31844622Ogura 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.
PubMed 31000377Hassani 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.
PubMed 37537979Vijayakumar G, Blank AT. Patient-reported outcome tools in musculoskeletal oncology. J Surg Oncol. 2023 Sep;128(3):418-424. doi: 10.1002/jso.27386.
PubMed 37537983Goulding 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.
PubMed 35236588Gutowski 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.
PubMed 27542644Walczak BE, Irwin RB. Sarcoma chemotherapy. J Am Acad Orthop Surg. 2013 Aug;21(8):480-91. doi: 10.5435/JAAOS-21-08-480.
PubMed 23908254Burningham 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.
PubMed 23036164
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07227961
- Acronym / sponsor ID
- HREBA.CC-25-0017
- Conditions
- Sarcoma, Giant Cell Tumor of Bone
- Keywords
- Patient reported outcomes, PROMIS, TESS, Mobility, Recovery, Surgery, App, Digital health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Toronto, Mayo Clinic
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Validate PROMIS as a patient outcome measure in sarcoma
- Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics
- 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.
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:
- Compare PROMIS to the current gold standard, the Toronto Extremity Salvage Score (TESS), in sarcoma
- Determine the minimal clinically important difference (MCID) for PROMIS in sarcoma
- Assess the feasibility and usability of an novel app for remote PROMIS and TESS administration, and mobility data collection
- Correlate PROMIS and TESS scores with mobility metrics to define recovery trajectories
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoma | – | Procedure: SurgeryAdult patients treated with surgery for bone and soft tissue sarcoma, and giant cell tumor of bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Operation, Procedure, Tumor resection, AmputationAny type of surgery performed to remove the primary tumor including resection, amputation, and bone stabilization. | Procedure or surgery | Sarcoma |
Primary outcome
Step count
Time frame: From enrolment to one year post-operative
Number of steps
Distance travelled
Time frame: From enrolment to 1 year post-operative
Kilometers
Flights of stairs climbed
Time frame: From enrolment to 1 year post-operative
Number of flights climbed
Gait asymmetry
Time frame: From enrolment to 1 year post-operative
Percentage
Distinct activity periods
Time frame: From enrolment to 1 year post-operative
Number of distinct activity periods >10 minutes
Total time active
Time frame: From enrolment to 1 year post-operative
Minutes
PROMIS Global Health
Time frame: From enrolment to 1 year post-operative
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.
PROMIS Self Efficacy
Time frame: From enrolment to 1 year post-operative
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.
PROMIS Pain Interference
Time frame: From enrolment to 1 year post-operative
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.
PROMIS Physical Function
Time frame: From enrolment to 1 year post-operative
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.
PROMIS Upper Extremity Function
Time frame: From enrolment to 1 year post-operative
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.
Toronto Extremity Salvage Score Lower Extremity
Time frame: From enrolment to 1 year post-operative
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.
Toronto Extremity Salvage Score Upper Extremity
Time frame: From enrolment to 1 year post-operative
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.
Maximal oxygen consumption (VO2 max)
Time frame: From enrolment to 1 year post-operative
Litres per minute. A higher VO2 max indicates that the body is more efficient at using oxygen to produce energy in the muscles.
Heart rate
Time frame: From enrolment to 1 year post-operative
Beats per minute
Heart rate variability
Time frame: From enrolment to 1 year post-operative
Milliseconds. Measures the variation in time between each beat of your heart, with a higher score generally indicating better physical fitness.
1 secondary outcome
App Survey
Time frame: Single collection time point at 1 year post-operative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Background: PubMed 25135249Tyser 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.
- Background: PubMed 24378399Hung 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.
- Background: PubMed 25935353Jensen 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.
- Background: PubMed 30114336Blank 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.
- Background: PubMed 17991929Garcia 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.
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- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Foothills Medical Centre, Arthur J Child Comprehensive Cancer Centre, University of Calgary
Calgary, Canada
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Giant Cell Tumor of Bone, run by University of Calgary at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step count (time frame: From enrolment to one year post-operative). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07227961, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.