SarcomaNCT07227961
Activation Sarcoma: 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
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. 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 smartphone
- Speaks English
Who cannot join
- Metastatic bone tumor
- Diagnosis of atypical lipomatous tumor
- Diagnosis of 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
- 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: Patient-Reported Outcomes and Smartphone-Derived Mobility After Bone and Soft Tissue Sarcoma Surgery: A Multicentre Prospective Cohort Study
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. Surgery is central to the treatment of bone and soft tissue sarcoma, yet post-surgical recovery is difficult to measure because of disease rarity, multiple different tumor types, and treatment variation. Therefore, the overall goal of the study is to use patient reported outcome measures and mobility data to define recovery trajectories in sarcoma patients undergoing surgery, and to evaluate a novel smartphone application (app) entailed Activation Health for collecting these data.
Participants will download the Activation Health app on their smartphone. A demographics survey and multiple patient reported outcome measures will be administered remotely through the Activation Health app. Surveys will be completed preoperatively and at 6 weeks, 12 weeks, 6 months 12 months, 16 months, 20 months, and 24 months postoperatively. Additionally, the app will passively track mobility metrics such as daily step count, stairs climbed, and gait parameters throughout the study period. At the end of study participation, an additional surveys will be administered assess participant phone use habits and app function.
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.
Surgery is central to the treatment of bone and soft tissue sarcoma, yet postoperative recovery is difficult to measure because of disease rarity, heterogeneity, and treatment variation. Legacy instruments such as the Toronto Extremity Salvage Score (TESS) have ceiling effects, limited health-domain coverage, and response burden. The Patient-Reported Outcomes Measurement Information System (PROMIS) uses short surveys across multiple health domains that may better capture recovery. 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 Health, a smartphone application (app) tailored to musculoskeletal oncology. Unlike general fitness or commercial health applications, Activation Health remotely administers patient reported outcome measures (PROMs) and passively captures mobility metrics. The continuous data collection aligns real-world mobility with clinical recovery timelines, offering a more precise view of patient outcomes.
The overall aim of the study is to validate the PROMIS as an outcome measure in the sarcoma population, and to evaluate the Activation Health app for remote PROM administration and mobility data collection.
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.
Specific Aims:
- Compare the responsiveness of five PROMIS short forms to the TESS for assessing recovery after sarcoma surgery
- Determine the minimal clinically important differences (MCID) for five PROMIS short forms in the sarcoma population
- Assess the feasibility and usability of Activation Health for remote PROM survey administration and mobility data collection in the sarcoma population
- Correlate PROM scores with mobility metrics to define recovery trajectories after sarcoma surgery
- Identify demographic and socioeconomic factors that influence survey responses and engagement with the Activation Health app in the sarcoma population
Methods:
Recruitment and Sample Size:
This is a prospective, multicentre longitudinal cohort study involving the University of Calgary, University of Toronto, Mayo Clinic Rochester and Mayo Clinic Arizona. All eligible patients will be seen by a musculoskeletal oncology surgeons at one of the participating sites. Adult patients (≥18 years) diagnosed with an operative bone or soft tissue sarcoma are eligible for inclusion. Tumors can be primary or recurrent, and can be located in the upper extremities, pelvis, or lower extremities. Participants must speak English to be included in the study. The investigators anticipate enrolling approximately 800 sarcoma patients based on current surgical volumes and patient capture rates for collecting quality of life and functional data.
Data Collection:
Clinical data will be collected by an approved member of the research team using the local electronic medical record and a standardized case repot form. Participants will download the Activation Health app on their smartphone. A demographics survey, TESS, and PROMIS physical function, upper extremity, pain interference, global health, and self efficacy surveys will be administered remotely through the Activation Health app and Qualtrics. Completion of these surveys will be prompted via push notifications preoperative and at 6 weeks, 12 weeks, 6 months 12 months, 16 months, 20 months, and 24 months postoperative. Mobility metrics will be passively collected by the app throughout study involvement. The mobility metrics of interest include but are not limited to step count, distance travelled, move time, flights of stairs climbed, walking steadiness, walking asymmetry, double support time, walking speed, and step length. Additionally, physiological parameters such as maximum oxygen consumption (VO2 max) will be collected from participants with a compatible smartwatch. At the end of study participation, an additional surveys will be administered assess participant phone use habits and app function.
To improve study accessibility, participants without a compatible smartphone or unwilling to use the Activation Health app can contribute survey data using Qualtrics. The secure Qualtrics survey links will be distributed via email or text message (patient preference) by an approved member of the study team at pre-specified data collection timepoints. In addition, participants may contribute their mobility data at the end of study involvement during an in-person visit. For apple device users, secure data transfer can be facilitated via the AirDrop feature and for Android users via Google Takeout.
Statistical Analysis:
Summary statistics will describe population demographic and clinical characteristics. Continuous data will be represented as means with standard deviation or medians with interquartile range, and categorical data as proportions. Individual-level socioeconomic status will be calculated using household income, education level, and occupation.
The sensitivity of the PROMIS physical function and upper extremity function domains will be independently compared to the TESS using effect size and standardized response means. These measures will allow for comparison of whether the T-scores scores changed by a small or large amount over time. Additionally, the aggregate score of all the PROMIS domains will be compared to TESS. Aggregate scores will be calculated by averaging the five domain-specific T-scores. 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. Ordinal logistic regression will be used to determine if mobility metrics collected form a smartphone are associated with patient-reported activity level, as assessed by a seven-point PGIC anchor question. Linear mixed-effects regression models will assess whether mobility changes are associated with changes in PROMIS and TESS scores.
The proportion of PROMIS and TESS questionnaires that are completed will be calculated. Logistic regression will be used to identify demographic factors that predict survey completion, with survey completion represented as a binary variable (yes or no).
- 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 two years postoperative
Distance travelled
Kilometers
Measured: From enrolment two years postoperative
Move time
Minutes
Measured: From enrolment two years postoperative
Flights of stairs climbed
Number of flights climbed
Measured: From enrolment to two years postoperative
Walking Steadiness
Percentage
Measured: From enrolment two years postoperative
Walking asymmetry
Percentage
Measured: From enrolment two years postoperative
Double Support Time
Percentage
Measured: From enrolment two years postoperative
Walking Speed
Kilometers/hour
Measured: From enrolment two years postoperative
Step Length
Centimeters
Measured: From enrolment two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
Demographic Survey
Measured: Enrolment
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes and Smartphone-Derived Mobility After Bone and Soft Tissue Sarcoma Surgery: A Multicentre 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.
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. Surgery is central to the treatment of bone and soft tissue sarcoma, yet post-surgical recovery is difficult to measure because of disease rarity, multiple different tumor types, and treatment variation. Therefore, the overall goal of the study is to use patient reported outcome measures and mobility data to define recovery trajectories in sarcoma patients undergoing surgery, and to evaluate a novel smartphone application (app) entailed Activation Health for collecting these data.
Participants will download the Activation Health app on their smartphone. A demographics survey and multiple patient reported outcome measures will be administered remotely through the Activation Health app. Surveys will be completed preoperatively and at 6 weeks, 12 weeks, 6 months 12 months, 16 months, 20 months, and 24 months postoperatively. Additionally, the app will passively track mobility metrics such as daily step count, stairs climbed, and gait parameters throughout the study period. At the end of study participation, an additional surveys will be administered assess participant phone use habits and app function.
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.
Surgery is central to the treatment of bone and soft tissue sarcoma, yet postoperative recovery is difficult to measure because of disease rarity, heterogeneity, and treatment variation. Legacy instruments such as the Toronto Extremity Salvage Score (TESS) have ceiling effects, limited health-domain coverage, and response burden. The Patient-Reported Outcomes Measurement Information System (PROMIS) uses short surveys across multiple health domains that may better capture recovery. 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 Health, a smartphone application (app) tailored to musculoskeletal oncology. Unlike general fitness or commercial health applications, Activation Health remotely administers patient reported outcome measures (PROMs) and passively captures mobility metrics. The continuous data collection aligns real-world mobility with clinical recovery timelines, offering a more precise view of patient outcomes.
The overall aim of the study is to validate the PROMIS as an outcome measure in the sarcoma population, and to evaluate the Activation Health app for remote PROM administration and mobility data collection.
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.
Specific Aims:
- Compare the responsiveness of five PROMIS short forms to the TESS for assessing recovery after sarcoma surgery
- Determine the minimal clinically important differences (MCID) for five PROMIS short forms in the sarcoma population
- Assess the feasibility and usability of Activation Health for remote PROM survey administration and mobility data collection in the sarcoma population
- Correlate PROM scores with mobility metrics to define recovery trajectories after sarcoma surgery
- Identify demographic and socioeconomic factors that influence survey responses and engagement with the Activation Health app in the sarcoma population
Methods:
Recruitment and Sample Size:
This is a prospective, multicentre longitudinal cohort study involving the University of Calgary, University of Toronto, Mayo Clinic Rochester and Mayo Clinic Arizona. All eligible patients will be seen by a musculoskeletal oncology surgeons at one of the participating sites. Adult patients (≥18 years) diagnosed with an operative bone or soft tissue sarcoma are eligible for inclusion. Tumors can be primary or recurrent, and can be located in the upper extremities, pelvis, or lower extremities. Participants must speak English to be included in the study. The investigators anticipate enrolling approximately 800 sarcoma patients based on current surgical volumes and patient capture rates for collecting quality of life and functional data.
Data Collection:
Clinical data will be collected by an approved member of the research team using the local electronic medical record and a standardized case repot form. Participants will download the Activation Health app on their smartphone. A demographics survey, TESS, and PROMIS physical function, upper extremity, pain interference, global health, and self efficacy surveys will be administered remotely through the Activation Health app and Qualtrics. Completion of these surveys will be prompted via push notifications preoperative and at 6 weeks, 12 weeks, 6 months 12 months, 16 months, 20 months, and 24 months postoperative. Mobility metrics will be passively collected by the app throughout study involvement. The mobility metrics of interest include but are not limited to step count, distance travelled, move time, flights of stairs climbed, walking steadiness, walking asymmetry, double support time, walking speed, and step length. Additionally, physiological parameters such as maximum oxygen consumption (VO2 max) will be collected from participants with a compatible smartwatch. At the end of study participation, an additional surveys will be administered assess participant phone use habits and app function.
To improve study accessibility, participants without a compatible smartphone or unwilling to use the Activation Health app can contribute survey data using Qualtrics. The secure Qualtrics survey links will be distributed via email or text message (patient preference) by an approved member of the study team at pre-specified data collection timepoints. In addition, participants may contribute their mobility data at the end of study involvement during an in-person visit. For apple device users, secure data transfer can be facilitated via the AirDrop feature and for Android users via Google Takeout.
Statistical Analysis:
Summary statistics will describe population demographic and clinical characteristics. Continuous data will be represented as means with standard deviation or medians with interquartile range, and categorical data as proportions. Individual-level socioeconomic status will be calculated using household income, education level, and occupation.
The sensitivity of the PROMIS physical function and upper extremity function domains will be independently compared to the TESS using effect size and standardized response means. These measures will allow for comparison of whether the T-scores scores changed by a small or large amount over time. Additionally, the aggregate score of all the PROMIS domains will be compared to TESS. Aggregate scores will be calculated by averaging the five domain-specific T-scores. 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. Ordinal logistic regression will be used to determine if mobility metrics collected form a smartphone are associated with patient-reported activity level, as assessed by a seven-point PGIC anchor question. Linear mixed-effects regression models will assess whether mobility changes are associated with changes in PROMIS and TESS scores.
The proportion of PROMIS and TESS questionnaires that are completed will be calculated. Logistic regression will be used to identify demographic factors that predict survey completion, with survey completion represented as a binary variable (yes or no).
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 (6 listed)
- Metastatic bone tumor
- Diagnosis of atypical lipomatous tumor
- Diagnosis of dermatofibrosarcoma protuberans
- Currently pregnant or planning pregnancy within 6 months
- Unwilling or unable to attend follow-up evaluations
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 two years postoperative
Number of steps
Distance travelled
Time frame: From enrolment two years postoperative
Kilometers
Move time
Time frame: From enrolment two years postoperative
Minutes
Flights of stairs climbed
Time frame: From enrolment to two years postoperative
Number of flights climbed
Walking Steadiness
Time frame: From enrolment two years postoperative
Percentage
Walking asymmetry
Time frame: From enrolment two years postoperative
Percentage
Double Support Time
Time frame: From enrolment two years postoperative
Percentage
Walking Speed
Time frame: From enrolment two years postoperative
Kilometers/hour
Step Length
Time frame: From enrolment two years postoperative
Centimeters
Heart rate variability
Time frame: From enrolment to two years postoperative
Milliseconds. Measures the variation in time between each beat of your heart, with a higher score generally indicating better physical fitness.
PROMIS Physical Function
Time frame: From enrolment to two years postoperative
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 two years postoperative
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 two years postoperative
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 Global Health
Time frame: From enrolment to two years postoperative
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 two years postoperative
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 two years postoperative
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 two years postoperative
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.
Demographic Survey
Time frame: Enrolment
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 2 Nov 2026.
- 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.
- Background: PubMed 31844622Ploetze 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.
- Background: PubMed 31000377Ogura 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.
- Background: PubMed 37537979Hassani 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.
- Background: PubMed 37537983Vijayakumar G, Blank AT. Patient-reported outcome tools in musculoskeletal oncology. J Surg Oncol. 2023 Sep;128(3):418-424. doi: 10.1002/jso.27386.
- Background: PubMed 35236588Goulding 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.
- Background: PubMed 27542644Gutowski 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.
- Background: PubMed 23908254Walczak BE, Irwin RB. Sarcoma chemotherapy. J Am Acad Orthop Surg. 2013 Aug;21(8):480-91. doi: 10.5435/JAAOS-21-08-480.
- 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.
Related trials for Sarcoma
RecruitingPhase 2
Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma
Phase 2, Zanzalintinib
Not yet recruitingPhase 1/2
Combination Immunotherapy Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruitingPhase 1
Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
Kaposi Sarcoma
RecruitingPhase 1
International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma
High-risk GD2 Positive Ewing Sarkoma
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 6 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 2 Nov 2026. 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 two years postoperative). The study lists 18 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 2 Nov 2026.