Eligibility Criteria Can Be Deceiving: How Direct and Indirect Exclusion Criteria Affects Recruitment of Under-Served Groups in Breast Cancer Trials

2022 ◽  
Author(s):  
Carolyn Moloney ◽  
Frances Shiely
Keyword(s):  
Breast Cancer ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Cancer Trials

scholarly journals Extent of Exclusions for Chronic Conditions in Breast Cancer Trials

2018 ◽  
Vol 2 (4) ◽  
Author(s):  
Ian M Kronish ◽  
Kathleen Fenn ◽  
Laura Cohen ◽  
Dawn L Hershman ◽  
Paige Green ◽  
...  
Keyword(s):  
Breast Cancer ◽  
National Cancer Institute ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Randomized Clinical Trials ◽  
Performance Status ◽  
Phase Iii ◽  
Test Case ◽  
Eligibility Criteria ◽  
Cancer Trials

Abstract Experts have expressed concerns that patients with chronic conditions are being excessively excluded from cancer randomized clinical trials (RCTs), limiting generalizability. Accordingly, we queried clinicaltrials.gov to determine the extent to which patients with chronic conditions were excluded from phase III cancer trials, using National Cancer Institute-sponsored breast cancer RCTs as a test case. Two physicians independently coded for the presence of 19 prevalent chronic conditions within eligibility criteria. They also coded for exclusions based on performance status and vague criteria that could have broadly excluded patients with chronic conditions. The search identified 58 RCTs, initiated from 1993 to 2012. Overall, 88% of trials had at least one exclusion for a chronic condition, performance status, or vague criterion. The three most commonly excluded conditions were chronic kidney disease, heart failure, and ischemic heart disease. Our study demonstrated that patients with prevalent chronic conditions were commonly excluded from National Cancer Institute-sponsored RCTs.

scholarly journals Assessment of genetic referrals and outcomes for women with triple negative breast cancer in regional cancer centres in Australia

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Lucie G. Hallenstein ◽  
Carol Sorensen ◽  
Lorraine Hodgson ◽  
Shelly Wen ◽  
Justin Westhuyzen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Genetic Testing ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Cancer Genetics ◽  
Eligibility Criteria ◽  
Pathogenic Variants ◽  
Genetics Services ◽  
Age Of Diagnosis ◽  
Over Time

Abstract Background Guidelines for referral to cancer genetics service for women diagnosed with triple negative breast cancer have changed over time. This study was conducted to assess the changing referral patterns and outcomes for women diagnosed with triple negative breast cancer across three regional cancer centres during the years 2014–2018. Methods Following ethical approval, a retrospective electronic medical record review was performed to identify those women diagnosed with triple negative breast cancer, and whether they were referred to a genetics service and if so, the outcome of that genetics assessment and/or genetic testing. Results There were 2441 women with newly diagnosed breast cancer seen at our cancer services during the years 2014–2018, of whom 237 women were diagnosed with triple negative breast cancer. Based on age of diagnosis criteria alone, 13% (31/237) of our cohort fulfilled criteria for genetic testing, with 81% (25/31) being referred to a cancer genetics service. Of this group 68% (21/31) were referred to genetics services within our regions and went on to have genetic testing with 10 pathogenic variants identified; 5x BRCA1, 4x BRCA2 and × 1 ATM:c.7271 T > G. Conclusions Referral pathways for women diagnosed with TNBC to cancer genetics services are performing well across our cancer centres. We identified a group of women who did not meet eligibility criteria for referral at their time of diagnosis, but would now be eligible, as guidelines have changed. The use of cross-discipline retrospective data reviews is a useful tool to identify patients who could benefit from being re-contacted over time for an updated cancer genetics assessment.

An assessment of fertility preservation practices among oncology providers.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 267-267
Author(s):  
Kathryn DeCarli ◽  
Joshua Ray Tanzer ◽  
Amelia Tajik ◽  
Camille Higel-Mcgovern ◽  
Christine Mary Duffy ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Fertility Preservation ◽  
Negative Binomial ◽  
Psychosocial Distress ◽  
Cancer Type ◽  
Eligibility Criteria ◽  
Patient Age ◽  
Cancer Subtypes ◽  
Mixed Effects Modeling ◽  
Patient Âgé

267 Background: Chemotherapy accelerates the natural decline of ovarian reserve. Women with a new cancer diagnosis commonly experience psychosocial distress around anticipated fertility loss. Fertility preservation via oocyte cryopreservation or temporary ovarian suppression with GnRH agonists may address this concern. ASCO guidelines recommend early discussion of fertility, preservation methods, psychosocial distress counseling, and referral to a fertility specialist. Disparities have been shown in fertility counseling rates based on patient age, race and cancer type. We sought to identify patterns in fertility preservation practices at Lifespan Cancer Institute. Methods: We retrospectively reviewed the medical record of female patients aged 18-45 years at time of solid tumor or lymphoma diagnosis in the years 2014-2019 who received chemotherapy. We compared documented fertility discussions and referrals across patient demographics and provider characteristics. Generalized mixed effects modeling was used with a logit link or a log link (negative binomial or zero inflated truncated Poisson distribution). Results: Among 181 patients who met eligibility criteria, the median age was 38 years with 140 (77.3%) White and 23 (12.7%) Hispanic. Only 112 patients (61.9%) had a conversation about fertility documented by a medical oncologist. Overall, 42 (23.2%) were referred to a fertility specialist and 28 (15.5%) received fertility preservation. Older patients and patients with higher parity were less likely to have a conversation about fertility with their oncologist (parity: OR = 0.33, p = 0.0020; age: OR = 0.64, p = 0.0439) or to be referred to a fertility specialist (parity: OR = 0.87, p = < 0.0001; age: OR = 0.97, p < 0.0001). Male providers were less likely to refer patients to a specialist (OR = 0.85, p = 0.0155) or discuss fertility (OR = 0.02, p = 0.0164). On average, male providers had much shorter conversations about fertility (Cohen’s d = 1.01, p = 0.0007). Male providers were slightly more likely to refer patients of color to a fertility specialist than White patients (OR = 1.26, p = 0.0684). Patients with breast cancer were more likely to have discussions about fertility than patients with other cancers ( p < 0.0001). Conclusions: We found disparities among patient age, parity, cancer type and provider sex in fertility preservation practices at our institution. Though not statistically significant, we also found disparities among patient race. Nearly all breast cancer providers at our institution are female and use a note template that includes fertility preservation. Providers in other cancer subtypes may be less accustomed to addressing fertility based on their patient populations. A major limitation is that we were only able to capture explicitly documented conversations. This needs assessment supports implementation of a systematic approach to promote fertility preservation as a quality measure across all cancer types.

Screening Criteria in Breast Cancer Trials: Are They Too Restrictive?

2015 ◽  
Vol 27 (9) ◽  
pp. 542
Author(s):  
D.K. Woolf ◽  
D.W. Miles ◽  
P.D. Nathan ◽  
E. Windmill ◽  
A. Makris
Keyword(s):  
Breast Cancer ◽  
Screening Criteria ◽  
Cancer Trials

scholarly journals Breast cancer patient-reported outcome of factors influencing cosmetic satisfaction after breast-conserving therapy

Breast Cancer ◽  
2021 ◽  
Author(s):  
A. T. P. M. Brands-Appeldoorn ◽  
A. J. G. Maaskant-Braat ◽  
L. Janssen ◽  
L. A. D. M. van Osch ◽  
V. C. G. Tjan-Heijnen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Body Image ◽  
Breast Surgery ◽  
Breast Conserving Therapy ◽  
Patient Reported Outcome ◽  
Breast Size ◽  
Exclusion Criteria ◽  
Non Invasive ◽  
Patient Reported ◽  
Relevant Factors

Abstract Background The aim of this study was to investigate which factors patients considered to be important for determining the degree of cosmetic satisfaction with regards to perceived body image after previous breast-conserving therapy (BCT). Methods Outcomes considered relevant by the patients were first identified using interviews. A questionnaire based on this group input was then devised and added to the physician-based Sneeuw questionnaire. Next, a quantitative study using this questionnaire was conducted in Dutch patients treated at least 6 months earlier for (non-) invasive breast cancer by BCT. Exclusion criteria were: previous mastectomy or BCT of the contralateral breast, BCT with nipple resection, metastatic disease, local recurrence or (previous) plastic breast surgery. Descriptive statistics were used throughout. Results A total of 149 patients (aged 36–87 years) completed the questionnaire. From this focus group input, the top three factors in overall importance (important or very important) for satisfaction were: ‘wearability of bra’ (67%), ‘breast sensitivity’ (59%) and ‘asymmetry’ (51%). Younger patients (< 55 years) considered ‘breast size’ to be most important, whereas ‘wearability of bra’ was most frequently reported by older patients (> 55 years). Time since BCT did not significantly influence the rating of relevant factors. Conclusion Patients consider ‘wearability of bra’, ‘breast sensitivity’ and ‘asymmetry’ as the most important factors when assessing their satisfaction with regards to cosmetic outcome and body image. These factors should be addressed in routine clinical practice during (pre) counseling.

5186 Breast cancer trials – is race an important factor?

2009 ◽  
Vol 7 (2) ◽  
pp. 315-316
Author(s):  
R. Lee ◽  
K. Mayer ◽  
G. Dranitsaris ◽  
S. Verma
Keyword(s):  
Breast Cancer ◽  
Cancer Trials

Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1515-1515
Author(s):  
John Stuart Peterson ◽  
Deborah Plana ◽  
Danielle Sara Bitterman ◽  
Skyler B Johnson ◽  
Benjamin Harris Kann
Keyword(s):  
Multivariable Analysis ◽  
Phase Iii ◽  
Word Count ◽  
Eligibility Criteria ◽  
Support Unit ◽  
National Priority ◽  
Clinical Trial Accrual ◽  
Unique Word ◽  
Cancer Trials ◽  
The Impact

1515 Background: Cancer clinical trial accrual across diverse socioeconomic and demographic groups is a national priority, yet up to 20% of trials fail due to poor accrual. Eligibility criteria content may contribute to poor accrual, but effects are challenging to measure. We sought to evaluate growth of eligibility criteria within NCI-affiliated cancer trials and the impact on trial accrual over the past decade. Methods: We conducted a retrospective study with the Aggregate Analysis of ClinicalTrials.gov (AACT) (abstracted: 02/02/2021). We included NCI-affiliated, interventional Phase II or III trials that initiated between 01/01/2008 and 12/13/2018. We excluded active and recruiting trials that lacked accrual data on the Cancer Trials Support Unit website. Trials whose status was “Withdrawn”, “Terminated”, or “Suspended” due to low accrual, or had less than 50% target accrual after two years active were deemed accrual failures. Eligibility criteria were extracted from inclusion and exclusion criteria and complexity was estimated by the number of unique content words, calculated by removing duplicates and stop words from the word count. Association of unique word count with accrual failure was evaluated by univariable and multivariable logistic regressions, adjusting for other predictors of low accrual identified in earlier research. Results: Of 1197 trials included, 231 (19.3%) failed due to low accrual. Eligibility criteria increased in length from a median of 214 (IQR [23, 282]) unique content words in 2008 to 417 (IQR [289, 514]) in 2018. The rate of trial accrual failure increased with unique word count decile from 11.8% in the first decile (12 to 112 words) to 29.4% in the tenth decile (445 to 750 words) (P = 0.004). On multivariable analysis, unique word count remained independently associated with low accrual (OR: 1.07 per decile, 95%CI [1.01-1.13], P = 0.02), as did Phase III and metastatic disease settings (Table). Conclusions: Eligibility criteria content has increased dramatically in the last decade in NCI-affiliated trials. Increasing eligibility criteria content associates strongly with accrual failure, even after adjusting for multiple known predictors of accrual. These findings underscore the need for efforts to simplify eligibility criteria to improve trial accrual. Further investigation is ongoing to determine specific criteria qualities that portend accrual failure.[Table: see text]

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