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"Dizon, Don S"
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Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial
2022
Background
Many cancer patients experience high symptom burden. Healthcare in the USA is reactive, not proactive, and doctor-patient communication is often suboptimal. As a result, symptomatic patients may suffer between clinic visits. In research settings, systematic assessment of electronic patient-reported outcomes (ePROs), coupled with clinical responses to severe symptoms, has eased this symptom burden, improved health-related quality of life, reduced acute care needs, and extended survival. Implementing ePRO-based symptom management programs in routine care is challenging. To study methods to overcome the implementation gap and improve symptom control for cancer patients, the National Cancer Institute created the Cancer-Moonshot funded
I
mproving the
M
anagement of sym
P
toms during
A
nd following
C
ancer
T
reatment (IMPACT) Consortium.
Methods
S
ymptom Management
IM
plementation of
P
atient
R
eported Outcomes in
O
ncology (SIMPRO) is one of three research centers that make up the IMPACT Consortium. SIMPRO, a multi-disciplinary team of investigators from six US health systems, seeks to develop, test, and integrate an
e
lectronic
sy
mptom
m
anagement program (eSyM) for medical oncology and surgery patients into the Epic electronic health record (EHR) system and associated patient portal. eSyM supports real-time symptom tracking for patients, automated clinician alerts for severe symptoms, and specialized reports to facilitate population management. To rigorously evaluate its impact, eSyM is deployed through a pragmatic stepped wedge cluster-randomized trial. The primary study outcome is the occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery. Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction. As a type II hybrid effectiveness-implementation study, facilitators and barriers to implementation are assessed throughout the project.
Discussion
Creating and deploying eSyM requires collaboration between dozens of staff across diverse health systems, dedicated engagement of patient advocates, and robust support from Epic. This trial will evaluate eSyM in routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations. This trial’s pragmatic design will promote generalizable results about the uptake, acceptability, and impact of an EHR-integrated, ePRO-based symptom management program.
Trial registration
ClinicalTrials.gov
NCT03850912
. Registered on February 22, 2019. Last updated on November 9, 2021.
Journal Article
Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health
by
Rosen, Rochelle K
,
Goldberg, Elizabeth M
,
Nugent, Nicole R
in
Abortion
,
Clinical research
,
Community
2022
Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators’ awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.
Journal Article
New-generation platinum agents for solid tumors
2009
Cisplatin was one of the first chemotherapeutic agents to exhibit broad efficacy in solid tumors and it remains among the most widely used agents in the treatment of cancer. Its introduction inspired great efforts to design similarly effective platinum agents that overcome the three main limitations of cisplatin: toxicity, tumor resistance and poor oral bioavailability. However, 40 years after the initial discovery of cisplatin, only two platinum agents have garnered US FDA approval: carboplatin and oxaliplatin. Although hundreds of promising agents were tested in clinical trials during the 1990s, only oxaliplatin made it past clinical development. For a brief period, the economic cost of these unsuccessful efforts retarded further efforts to develop new agents. However, two exciting platinum agents have been brought to Phase III trials: satraplatin in hormone-refractory prostate cancer and picoplatin in small-cell lung cancer. If successful, they may inspire a new effort to bring better-designed platinum agents to market. This article reviews the clinical development of platinum agents to date and speculates on the role of platinum agents in the near future.
Journal Article
PARP inhibitors for targeted treatment in ovarian cancer
2017
Poly(ADP-ribose) polymerase (PARP) inhibitors emerged as the first targeted treatment for ovarian cancer, and are selectively active for women with mutations in BRCA1 and BRCA2 (mBRCA). On the basis of data showing activity (measured by the proportion of patients who achieved an objective response),1 the PARP inhibitor olaparib received US Food and Drug Administration (FDA) approval in 2014 specifically for women with germline mBRCA-associated (gBRCA) recurrent ovarian cancer.2
Journal Article
Assessing Health Information Seeking Behaviors Among Targeted Social Media Users Using an Infotainment Video About a Cancer Clinical Trial: Population-Based Descriptive Study
2025
Lack of information, awareness, and misconceptions about clinical trials are major barriers to cancer clinical trial participation. Digital and social media are dominant sources of health information and offer optimal opportunities to improve public medical awareness and education by providing accurate and trust-worthy sources of health information from reliable sources. Infotainment, material intended to both entertain and inform, is an effective strategy for engaging and educating audiences that can be easily disseminated using social media and may be a novel way to improve awareness of and recruitment in clinical trials.
The purpose of this study was to evaluate whether an infotainment video promoting a clinical trial, disseminated using social media, could drive health information seeking behaviors.
As part of a video series, we created an infotainment video focused on promotion of a specific cancer clinical trial. We instituted a dissemination and marketing process on Facebook to measure video engagement and health information seeking behaviors among targeted audiences who expressed interest in breast cancer research and organizations. To evaluate video engagement, we measured reach, retention, outbound clicks, and outbound click-through rate. Frequencies and descriptive statistics were used to summarize each measure.
The video substantially increased health information seeking behavior by increasing viewership from 1 visitor one month prior to launch to 414 outbound clicks from the video to the clinical trial webpage during the 21-day social media campaign period.
Our study shows that digital and social media tools can be tailored for specific target audiences, are scalable, and can be disseminated at low cost, making it an accessible educational, recruitment, and retention strategy focused on improving awareness of clinical trials.
ClinicalTrials.gov NCT03418961.
Journal Article
The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method
by
Smith, Justin D.
,
Norton, Wynne E.
,
Osarogiagbon, Raymond U.
in
Common data elements
,
Health Administration
,
Health Policy
2023
Background
Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time.
Methods
The development and initial evaluation of the LISTS method was conducted within the
I
mproving the
M
anagement of Sym
P
toms during
A
nd following
C
ancer
T
reatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer Moonshot
SM
). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User’s Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study.
Results
Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies.
Conclusions
The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.
Journal Article
Using social media for patient-driven cancer research
2023
Social media has revolutionized health-care communication across all areas of medicine, and the field of oncology is no exception. When it comes to cancer research, social media has had a major impact. Here we highlight the role of social media in promoting patient-driven cancer research.Social media has revolutionized health-care communication across medicine, particularly in the field of oncology. In this Comment, Manochakian and Dizon highlight the role of social media in promoting patient-driven cancer research to benefit all.
Journal Article
Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning
by
Kuharic, Maja
,
Smith, Justin D.
,
Flores, Ann Marie
in
Cancer therapies
,
Collective action
,
Confirmatory factor analysis
2025
Background
The Normalization MeAsure Development (NoMAD) questionnaire is used to assess implementation processes based on Normalization Process Theory (NPT). However, its psychometric properties have not been extensively evaluated. This study aimed to examine the factorial validity, internal consistency, and measurement invariance at both scale and item levels of the NoMAD across three hybrid effectiveness-implementation studies determining the impact of routine symptom surveillance and guideline-based symptom management interventions in ambulatory oncology care settings.
Methods
A cross-sectional survey was conducted with 328 healthcare personnel (74.% clinicians) participating in the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium between 2019 and 2024. Confirmatory factor analysis (CFA) tested the hypothesized four-factor structure (coherence, cognitive participation, collective action, reflexive monitoring). Internal consistency was assessed with McDonald's omega and Cronbach's alpha coefficients (> 0.70 acceptable). Measurement invariance was tested across research centers, professional roles, and years in current roles using multi-group CFA. Model fit was defined by standard fit indices (Comparative Fit Index (CFI) and Tucker-Lewis Index (TLI) values ≥ 0.95, Root Mean Square Error of Approximation (RMSEA) values ≤ 0.06, and Standardized Root Mean Square Residual (SRMR) values ≤ 0.08. Differential item functioning (DIF) was evaluated using ordinal logistic regression and item response theory methods (ΔR2 ≥ 0.02 indicative of meaningful DIF).
Results
The four-factor model demonstrated good fit to the data (CFI = 0.97, TLI = 0.96, RMSEA = 0.06, SRMR = 0.05). All factor loadings were statistically significant (
p
< 0.001), ranging from 0.606 to 0.871. Internal consistency was satisfactory for all four constructs (Omega range: 0.789–0.864, Cronbach's alpha range: 0.782–0.863). The NoMAD exhibited configural, metric, and scalar invariance across research centers, roles, and years in the current role. One item (\"The staff agree that the intervention is worthwhile\") showed uniform DIF across healthcare systems (ΔR2 = 0.047), but no DIF was found by role or years in the current role.
Conclusions
This study supports the factorial validity, internal consistency, and measurement invariance of the NoMAD across three oncology implementation efforts. The presence of DIF in one item provides an opportunity for refinement in this healthcare context. Researchers and practitioners can use the NoMAD to assess and compare implementation processes, informing the development and evaluation of implementation strategies.
Trial registration
(ClinicalTrials.gov ID NCT03850912, NCT03892967, NCT03988543).
Journal Article
Predictors and impact of survivorship care plans and survivorship care visits
2024
PurposeWe performed this study to characterize the population at the Lifespan Cancer Institute (LCI) who received a survivorship care plan (SCP) with or without a survivorship care visit (SCV) to determine both the impact on specialty referrals and the demographic and clinical predictors of SCPs and SCVs.MethodsWe retrospectively reviewed EMR records on 1960 patients at LCI between 2014 and 2017 for SCPs and SCVs and extracted demographics, distress thermometer (DT) scores collected at the time of initial presentation, and subsequent referrals. We evaluated the bivariate associations of SCP and SCV with continuous and categorical factors and assessed the adjusted effect of these factors on receipt of SCP and SCV independently. All analyses were performed in R v4.0.2.ResultsSCPs were completed in 740 (37.8%) patients, and of those, 65.9% had a SCV. The mean age was 63.9, 67% were female, and 51.2% were married or partnered. Patients treated for breast, lung, and prostate cancers most received an SCP. Compared to SCP alone, the SCV was associated with more specialty referrals. Those who were younger and had breast cancer were more likely to receive a SCP, and those who were younger and female and had breast cancer were more likely to receive a SCV.ConclusionsGender, age, and type of cancer are significant predictors of receipt of SCP and SCV. Patients who received either SCP, SCV, or both were more likely to receive specialty referrals than those who received neither.Implications for Cancer Survivors.Identifying predictive factors of SCP and SCV can help facilitate earlier receipt of specialty services and specialty referrals as needed.
Journal Article