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
Conditions: Sarcoma, Giant Cell Tumor of Bone
Sponsor: University of Calgary

 
 
 
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Study Protocol and Sta.s.cal Analysis Plan 
 
Title: Evalua&ng the Implementa&on, U&lity, and Clinical Importance of the Pa&ent-Reported 
Outcome Measure Informa&on System (PROMIS) in Sarcoma Pa&ents: A Mul&-Centered 
Prospec&ve Cohort Study 
 
Version: 1.0 
 
Date: November 3, 2025 
 
NCT Number: *** 
 
Primary Inves7gator: Dr. Joe Kendal 
 
Co-Inves7gators: 
Dr. Michael Monument 
Dr. Shannon Puloski  
Dr. Jay Wunder 
Dr. Aaron Gazendam 
Dr. Kim Tsoi 
Dr. Peter Ferguson 
Dr. MaKhew Houdek 
Dr. Krista Goulding 
 
 
 
 
 

 
 
 
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Table of Contents 
1 Study ObjecPves ........................................................................................................................................ 3 
1.1 Problem to be invesPgated ................................................................................................................. 3 
1.2 Speciﬁc Aims ....................................................................................................................................... 3 
1.3 Expected Outcomes ............................................................................................................................ 3 
2 Background ................................................................................................................................................ 4 
2.1 Overview of Sarcoma .......................................................................................................................... 4 
2.2 Study RaPonale ................................................................................................................................... 4 
2.3 Hypotheses ......................................................................................................................................... 4 
3 Study Design .............................................................................................................................................. 5 
3.1 Summary of Design ............................................................................................................................ 5 
3.2 Study DuraPon .................................................................................................................................... 5 
3.3 Inclusion Criteria ................................................................................................................................. 5 
3.4 Exclusion Criteria ................................................................................................................................ 5 
3.5 Data CollecPon ................................................................................................................................... 5 
3.6 Data Storage ....................................................................................................................................... 7 
3.7 PotenPal Beneﬁts ............................................................................................................................... 7 
3.8 PotenPal Risks ..................................................................................................................................... 7 
3.9 Clinical Consent .................................................................................................................................. 8 
4 StaPsPcal Analysis ...................................................................................................................................... 9 
4.1 Sample Size ......................................................................................................................................... 9 
4.2 Data Analysis ...................................................................................................................................... 9 
5 Study Management ................................................................................................................................. 11 
5.1 Day to Day Management .................................................................................................................. 11 
5.2 Funding ............................................................................................................................................. 11 
5.3 Management of ConﬁdenPal Health Data ........................................................................................ 11 
5.4 Data Sharing ..................................................................................................................................... 11 
5.5 Regulatory Binder ............................................................................................................................. 12 
6 References ............................................................................................................................................... 13 
 
 
 
 

 
 
 
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1 Study Objec-ves 
1.1 Problem to be inves4gated 
The purpose of this study is to invesPgate the PaPent-Reported Outcome Measure InformaPon System 
(PROMIS) and mobility in paPents with sarcoma treated surgically using a novel smartphone applicaPon, 
ACTIVATION (AcPvity Capture To InvesPgate Voluntary AcTivity In Orthopaedic populaPoNs). 
1.2 Speciﬁc 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 a novel app for remote quesPonnaire administraPon and 
mobility data collecPon 
4. Correlate PROMIS and TESS scores with mobility metrics to deﬁne recovery trajectories 
5. IdenPfy demographic and socioeconomic factors that inﬂuence app engagement 
 
1.3 Expected Outcomes 
1. ValidaPon of PROMIS as an outcome measure for sarcoma paPents and comparison to the TESS 
2. Determine the MCID for PROMIS in sarcoma 
3. ValidaPon of the ACTIVATION app 
4. Establish longitudinal recovery trends in PROMIS, TESS, and mobility metrics following surgical 
management 
5. Understand barriers to app engagement 
 
 

 
 
 
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2 Background 
2.1 Overview of Sarcoma 
Bone and sog Pssue sarcomas are rare mesenchymal-derived neoplasms, making up about 1% of all 
adult cancers.1 Management typically involves radiaPon therapy, chemotherapy, and surgical resecPon, 
with or without limb reconstrucPon.2–4 The diagnosis, intensive treatment regimen, and surgery-induced 
deﬁcits signiﬁcantly impact paPent quality of life and funcPon. EvaluaPng outcomes in sarcoma is 
challenging due to disease heterogeneity, complexity, and variaPon in surgical strategy.  
PaPent-reported outcomes measures (PROMs) are crucial for evaluaPng treatment outcomes and 
facilitaPng paPent-centered care.5,6 TradiPonal validated PROMs, like the TESS, have signiﬁcant ﬂoor and 
ceiling eﬀects. PROMIS assesses physical, mental, and social well-being, using item response theory in a 
standardized manner for precise and sensiPve measures.7 It has been validated and uPlized across 
orthopaedic and non-orthopaedic populaPons.8 However, its uPlity, sensiPvity, and clinical signiﬁcance in 
bone and sog Pssue sarcoma paPents has not been deﬁned.9  
2.2 Study Ra4onale  
A criPcal but under invesPgated parameter in musculoskeletal oncology is paPent mobility. Mobility 
metrics are inadequately measured due to the lack of appropriate standardized methodologies for 
capturing granular longitudinal changes. EvaluaPng longitudinal changes in PROMIS scores and mobility 
parameters may provide signiﬁcant insight into post-operaPve recovery for sarcoma paPents.10-12 
Remote data collecPon for PROMIS and funcPonal data enhances accessibility and convenience for 
paPents already burdened with mulPple appointments.26 Remote data capture has proven eﬀecPve in 
other orthopaedic populaPons, such as hip and knee arthroplasty, improving PROM compliance.13 The 
development of a remote capture system to record longitudinal changes in PROMS and paPent mobility 
has the potenPal to enhance musculoskeletal oncology research and ulPmately improve paPent-
centered cancer care. 
2.3 Hypotheses  
We hypothesize that the ACTIVATION app will successfully capture PROMIS scores at Pmed intervals and 
conPnuous mobility metrics, demonstraPng high compliance, accuracy, and paPent saPsfacPon due to its 
user-friendly design. Longitudinal changes in PROMIS global health (GH), pain interference (PI), self-
eﬃcacy (SE), upper extremity funcPon (UEF), and physical funcPon (PF) scores are expected to correlate 
signiﬁcantly with post-operaPve recovery trajectories in sarcoma paPents. 
 

 
 
 
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3 Study Design  
3.1 Summary of Design 
This is a prospecPve, mulPcentre longitudinal cohort study involving the University of Calgary, Mount 
Sinai Hospital in Toronto, Mayo Clinic Minnesota and Mayo Clinic Arizona.  
3.2 Study Dura4on 
ParPcipant recruitment will last for four years and paPents will be followed for one year ager enrolment, 
resulPng in a total study duraPon of 5 years. 
3.3 Inclusion Criteria  
All eligible paPents will be seen by a musculoskeletal oncology surgeons at one of the parPcipaPng sites. 
All adult paPents (≥18 years) diagnosed with bone sarcoma, sog Pssue sarcoma, or giant cell tumor of 
bone undergoing operaPve tumor resecPon are eligible. Tumors can be primary or recurrent, and can be 
located in the pelvis, lower extremiPes, or upper extremiPes. PaPent must speak English and have an 
iPhone or Android to be included in the study. 
3.4 Exclusion Criteria 
PaPents with metastaPc bone tumors, atypical lipomatous tumors, and dermatoﬁbrosarcoma 
protuberans will be excluded. Pregnant paPents and paPents unwilling or unable to aKend all follow-up 
evaluaPons will be excluded. Lastly, paPents with signiﬁcant cogniPve impairment or communicaPon 
barriers that prevent informed consent and independent complePon of study quesPonnaires will be 
excluded.  
3.5 Data Collec4on 
Study parPcipants will be asked to complete a demographic intake form and clinical data will be obtained 
through the local electronic medical record. ParPcipants will be asked to download the ACTIVATION app 
on their phone. The TESS and PROMIS GH, PI, SE, UEF, and PF quesPonnaires will be administered 
through the ACTIVATION app. ComplePon of these forms will be prompted via push noPﬁcaPons 
preoperaPvely and at six-weeks, three-months, six-months, and 1-year post-operaPve. Mobility metrics 
will be passively collected by the app throughout study involvement. The mobility metrics of interest 
include step count, distance travelled, ﬂights climbed, gait asymmetry, disPnct acPvity periods (>10 
minutes), and total Pme spent in acPvity. AddiPonally, physiologic parameters will be collected from 
parPcipants with a compaPble smartwatch including maximum oxygen consumpPon (VO2 max), heart 
rate, and heart rate variability. At the end of study parPcipaPon, two addiPonal surveys will be 
administered. The ﬁrst survey will assess phone carrying habits in the parPcipant. The second survey will 
gather feedback on the app's interface, navigaPon, and overall user experience. These measurements 
are considered to be above standard pracPce. Below is a list of the data that is planned to be collected: 
 

 
 
 
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Demographic informaPon: 
• 
Date of birth 
• 
Sex 
• 
Body mass index 
• 
Ethnicity 
• 
EducaPon level 
• 
Employment status 
• 
Medical history 
• 
Substance use 
 
Clinical informaPon:  
• 
Diagnosis date  
• 
Tumor type 
• 
Tumor locaPon 
• 
Biopsy date 
• 
Biopsy type 
• 
Surgery date 
• 
Surgical procedure 
• 
Associated plasPcs surgical procedures (e.g. skin grag or ﬂap) 
• 
ApplicaPon of negaPve pressure dressing 
• 
Other local or systemaPc treatment (chemotherapy, radiaPon therapy) 
• 
Surgical complicaPons 
 
IntervenPon variables: 
• 
Step count 
• 
Distance travelled 
• 
Flights climbed 
• 
Gait asymmetry 
• 
DisPnct acPvity periods (>10 minutes) 
• 
Total Pme spent in acPvity  
• 
VO2 max* 
• 
Heart rate* 
• 
Heart rate variability* 
• 
PROMIS scores 
• 
TESS scores 
 
*Measures that will be obtained only in paPents with a compaPble smart watch 
 

 
 
 
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3.6 Data Storage 
The ACTIVATION app complies with University of Calgary data usage regulaPons and Apple’s HealthKit 
guidelines. All health and acPvity data is encrypted by default on iPhones and is available only to the 
user. Study data will always be encrypted, when the ACTIVATION app transmits the data to our servers it 
will occur via an encrypted tunnel through a Cloudﬂare relay (Cloudﬂare’s zero trust network access), to 
a secure, ethics-approved research server hosted by University of Calgary research services. The research 
server is protected from any outside access via the Cloudﬂare tunnel and has no externally addressable 
IP address. The server runs a Postgres database which will further encrypt and store all data and is 
conPnuously scanned for vulnerabiliPes by the University of Calgary research services. The data 
stored on the Postgres database will be associated to parPcipants unique device code and will contain no 
informaPon about the parPcipant directly and will be replicated within the server cluster for redundancy. 
Following all the best pracPces outline by University of Calgary research services. All potenPal 
documents that can link a subject to their encrypted ID will be stored in separate locaPon on a OneDrive 
level 4 server that is associated with the study. Aggregated research data compiled by querying the 
database will also be stored on university of Calgary OneDrive servers in an encrypted folder separate 
from other study documents. IdenPﬁable medical informaPon will be stored in our MSK oncology 
database using the web-based Research Electronic Data Capture (REDCap) server as previously approved 
in HREBA.CC-20-0335. IdenPfying data that will be stored in this database includes paPent ULI or PHN 
and date of birth. This will be included for the purpose of coordinated data collecPon and data audits. 
Access to both cloud and REDCap servers is limited to personnel directly involved with the study and is 
further restricted, based on their responsibiliPes within the study. Any physical documentaPon 
pertaining to the study will be stored in a secured lockbox within the orthopaedic oncology research 
oﬃce at the Arthur Child Comprehensive Cancer Centre and be only accessible to the immediate study 
team. This is a secured locaPon, accessible only with clearance approved by the University of Calgary and 
AHS, and is under the supervision of the Orthopedic Oncology research team. Any output from the 
database including exported ﬁles for analysis and publicaPon of the results will not include any 
idenPfying informaPon. Security concerns and the management of these concerns is outlined in the 
PotenPal Risks 3.8.  
3.7 Poten4al Beneﬁts 
There is no direct beneﬁt to the parPcipant from engaging in the study. However, by recording and 
evaluaPng longitudinal changes in PROMIS scores and mobility proﬁles, the study will provide valuable 
insights into the trajectory of post-operaPve funcPonal recovery and idenPfy criPcal periods for 
intervenPon aimed at enhancing paPent-centered cancer care. To increase accessibility and convenience 
for paPents, all necessary study parPcipaPon can be completed remotely through the ACTIVATION app, 
alleviaPng any monetary, travel, and emoPonal burdens associated with in-person visits to our site. 
3.8 Poten4al Risks  
This study introduces limited risk to the parPcipant. This study will uPlize limited idenPﬁable data and 
standard storage procedures for conﬁdenPal health informaPon. To manage the potenPal risk of data 
being exposed to anyone outside the study team, our app does not have access to any other data or 

 
 
 
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idenPﬁable informaPon on the parPcipant's iPhone. All data will have been encrypted with the operaPng 
system already, and all data extracted using the ACTIVATION app will be further encrypted for transport 
to our encrypted database on a secure server as explained in Data Storage 3.6. All acPvity data will only 
be connected to the parPcipant's study ID in the database, and the key to idenPfy parPcipants' acPvity 
will also be encrypted, stored separately from the database, and will be restricted such that only 
necessary study personnel will have access to it. Absolutely no GPS type data will be collected, and the 
iPhone app will not have access to any other data stored on the parPcipant's phone. We will also consult 
with University of Calgary IT Services as needed prior to the implementaPon of our app for any study 
parPcipants. PaPent contact can be limited to the iniPal paPent recruitment into the study but does not 
need to be limited to this study milestone. Any published results from this study will be in aggregate and 
will not be linked to idenPﬁable paPent informaPon. We have already addressed partnership risks with 
our app developer through university mediaPons, including intellectual property sPpulaPons. 
3.9 Clinical Consent 
ParPcipant consent is requested. The nature and scope of this study involves minimal risk to paPents’ 
welfare, as the study does not involve intervenPons that will interfere with their rouPne cancer care. It 
would be inappropriate to seek consent from authorized third parPes acPng on behalf of these 
individuals as the study requires paPents to be free of any cogniPve impairments. Only informaPon 
necessary for study objecPves will be collected. PaPent privacy and conﬁdenPality will be strictly 
followed as per provincial or state policy. The study team consists of acPve clinical staﬀ involved in the 
care of the paPent populaPon of interest or those with research experPse for the design or analysis of 
the study. A small number of researchers will have access to paPent informaPon, which will be treated 
with respect and in a conﬁdenPal manner. The idenPﬁable paPent informaPon will include a PHN or ULI 
and date of birth.  
 
 
 

 
 
 
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4 Sta-s-cal Analysis 
4.1 Sample Size 
We will include all eligible subjects idenPﬁed by musculoskeletal oncology surgeons at each site. We 
hope to enroll as many paPents as possible into our study, however, anPcipate enrolling approximately 
800 sarcoma paPents during the study period. This esPmate is based on current surgical volumes and 
paPent capture rates for collecPng quality of life and funcPonal data.  
4.2 Data Analysis 
Descrip&ve sta&s&cs will be employed to summarize the demographic and clinical 
characteris&cs of the study popula&on. Longitudinal changes in PROMIS scores over &me will be 
analyzed using linear mixed-eﬀects models, adjus&ng for poten&al confounders. Comparison 
with tradi&onal outcome measures, such as the TESS will be conducted using correla&on 
coeﬃcients, Bland-Altman plots, and linear regression models. Given the considerable 
heterogeneity within the sarcoma popula&on, subgroups based on loca&on and tumor type 
(soR &ssue vs. bone) will be created and analyzed.  
 
The study aims to establish minimal clinically important differences (MCIDs) for PROMIS scores 
through distribution-based and anchor-based methods. In the current study, the distribution-
based MCIDs will be calculated utilizing the one-half SD of baseline scores and the one-half SD 
of change scores within the groups from baseline to 12-month follow-up. In anchor-based 
methods, the MCID is established by relating a difference in outcome scores to a patient-
important improvement or deterioration that is captured by an independent measure (the 
anchor) that is itself interpretable. For our anchor, we will utilize a questionnaire, “compared to 
your initial evaluation, how would you describe you function (pain/overall health) now?” 
Responses will range from “Much improved, improved, slightly improved, no change, slight 
worse, worse, much worse”. This outcome is patient centered, easily understandable and 
relevant to patients. Patients who reported changes from one adjacent score to the next (e.g. 
no difference to slightly improved) represented a small but meaningful change equivalent to 
the MCID. 
 
For the anchor-based approach, the relationship between changes in the external anchor and 
changes in PROMIS will be examined using receiver operating characteristic (ROC) curve 
analysis. The ROC method plots the sensitivity against 1-specificity for the range of PROMIS 
scores in relation to the probability of detecting improvement as judged by a change score of 
one point on the external anchor. The ROC analysis will be performed to differentiate between 
patients with PROMIS scores who reported a change score of 0 on the external anchor and 
those who had change score of +1 on the external anchor. The MCID cut-offs were estimated by 
calculating the Youden Index which balances the sensitivity and specificity of the PROMIS 
change thresholds based on the external anchor. Youden’s Index provides an overall indicator 
of test performance and is recommended when establishing MCIDs based on the ROC analysis.  
 

 
 
 
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A survey will be administered at the end of each pa&ent’s study par&cipa&on to assess the app 
func&on and user-friendliness. We will also explore phone use habits, including where pa&ents 
keep their phone while walking and how oRen they have it with them. These methods will help 
us gather detailed feedback regarding the user experience of the app including ease of 
naviga&on, clarity of instruc&ons and overall sa&sfac&on. In assessing feasibility, we will record 
the propor&on of pa&ents who u&lize the app. This will involve tracing download and 
registra&on rates as well as ac&ve usage sta&s&cs. We will compare PROM comple&on rates 
between pa&ents who use the app and those who complete the PROMs exclusively in the clinic. 
Logis&c regression analysis will explore factors inﬂuencing PROM comple&on rates through the 
app, including pa&ent demographics and socioeconomic status. 
 
 
 

 
 
 
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5 Study Management 
5.1 Day to Day Management  
CoordinaPon of the study will be the responsibility of the principal invesPgator (J. Kendal) and the 
orthopedic oncology research team.  
5.2 Funding 
The study concept was iniPated using the principal invesPgator’s operaPonal grant, but a grant has 
recently been obtained from the American Academy of Orthopaedic Surgeons and Musculoskeletal 
Tumor Society (US $110,000) for this mulPcenter trial. We also have received the following smaller 
grants to support this study: Orthopaedic Research Porpolio Catalyst Grant CompePPon ($25,000) and 
Calgary Surgical Research Development Fund ($4000). The research team will conPnue to pursue other 
grant and external funding opportuniPes. 
5.3 Management of Conﬁden4al Health Data  
We will take all appropriate measures to protect the privacy of included paPents. A small number of 
researchers will have access to paPent informaPon, which will be treated with respect and in a 
conﬁdenPal manner. All paPent data will be stored on a secure, cloud- and web-based REDCap databases 
developed in accordance with insPtuPonal regulaPons; thus, no paPent data is stored on the local hard 
drives of data entry computers. This sogware is commonly used by researchers at the University of 
Calgary. The HIPAA privacy rules and HIPAA security rules mandate that covered enPPes have in place 
appropriate policies and procedures to protect the conﬁdenPality and security of protected health 
informaPon. REDCap meets these requirements. REDCap is a 21 CFR part II compliant research sogware 
applicaPon that limits user access to the appropriate study, site, and role. Online database control 
sogware will be uPlized to safely maintain conﬁdenPality, comply with record retenPon, and provide us 
with the capability to enter informaPon from mulPple sites.  
Personal informaPon such as name, address, telephone number, and insurance numbers will never be 
entered in spreadsheets for analysis. A limited amount of idenPfying informaPon will be collected purely 
for the purpose of coordinated data entry and data audits. This informaPon will not be included in 
analysis or any data outputs. Following the complePon of the study, research data will be kept securely 
in accordance with the policy for long-term storage from the University of Calgary and the HREBA. When 
the mandated period expires, all research data will be destroyed. The published results from this study 
will be in aggregate and will not be linked to idenPﬁable paPent informaPon. 
5.4 Data Sharing 
Anonymized data will not be shared beyond the immediate research team. The University of Calgary is 
the lead site and Clinical Trial Agreements (CTA) will be put in place between sites. 

 
 
 
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5.5 Regulatory Binder 
The regulatory binder for the study will be kept in the orthopedic oncology research oﬃce and contain 
all perPnent study informaPon. 
 
 

 
 
 
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