Participation of elderly gynecological cancer patients in clinical trials

Trillsch, Fabian; Oskay-Özcelik, Gülten; Chekerov, Radoslav; Bleich, Christiane; Oliveira‐Ferrer, Leticia; Grimm, Donata; Kuerti, Sascha; Mueller, Volkmar; Suling, Anna; Schmalfeldt, Barbara; Sehouli, Jalid; Mahner, Sven; Woelber, Linn

doi:10.1007/s00404-018-4886-2

Cited by 10 publications

(15 citation statements)

References 27 publications

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“…Table 1 summarizes the characteristics of the studies included in the evidence synthesis. Most studies (12 of 13; 92%) 31,[36][37][38][69][70][71][72][73][74][75][76] were observational studies (9 cross-sectional, [36][37][38][71][72][73][74][75][76] 2 cohort, 31,70 and one case-control 69 ) and evaluated only barriers. Only one interventional randomized controlled trial (RCT) 42 met the final inclusion criteria.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Only one interventional randomized controlled trial (RCT) 42 met the final inclusion criteria. Six studies 31,38,[73][74][75][76] were published in 2010 or later, and 2 36,69 were published before 2004. Most studies (8 of 13; 62%) 31,36,38,42,69,71,72,75 were based in the United States.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Most studies (8 of 13; 62%) 31,36,38,42,69,71,72,75 were based in the United States. Solid tumor malignancies were the most prevalent cancer type 70 Moore 2004, 71 Basche 2008 72 After 2010 6 Javid 2012, 31 Freedman 2018, 38 Hamaker 2013, 73 Ayodel 2016, 74 McCleary 2018, 75 Prieske 2018 76 Country of origin United States 8 Javid 2012, 31 Kornblith 2002, 36 Freedman 2018, 38 Kimmick 2005, 42 Kemeny 2003, 69 Puts 2009, 70 Moore 2004, 71 31 Kornblith 2002, 36 Freedman 2018, 38 Kimmick 2005, 42 Kemeny 2003, 69 Puts 2009, 70 Moore 2004, 71 Basche 2008, 72 Hamaker 2013, 73 Ayodel 2016, 74 36 Freedman 2018, 38 Kimmick 2005, 42 Hamaker 2013, 73 McCleary 2018 75 Patients 5 Townsley 2006, 37 Puts 2009, 70 Basche 2008, 72 Ayodel 2016, 74 Prieske 2018 76 Both 3 Javid 2012, 31 Kemeny 2003, 69 Moore 2004…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Multiple institutions 9 Javid 2012, 31 Kornblith 2002, 36 Kimmick 2005, 42 Kemeny 2003, 69 Moore 2004, 71 Basche 2008, 72 Hamaker 2013, 73 McCleary 2018, 75 Prieske 2018 76 Single institution 3 Townsley 2006, 37 36 Townsley 2006, 37 Freedman 2018, 38 Moore 2004, 71 Basche 2008, 72 Hamaker 2013, 73 Ayodel 2016, 74 McCleary 2018, 75 Prieske 2018 76 Cross-sectional 9 Javid 2012, 31 Kornblith 2002, 36 Townsley 2006, 37 Freedman 2018, 38 Kemeny 2003, 69 Puts 2009, 70 Moore 2004, 71 Basche 2008, 72 Hamaker 2013, 73 Ayodel 2016, 74 McCleary 2018, 75 Prieske 2018 76 Surveys 11 Javid 2012, 31 Kornblith 2002, 36 Townsley 2006, 37 Freedman 2018, 38 Kemeny 2003, 69 Moore 2004, 71 Basche 2008, 72 Hamaker 2013, 73 Ayodel 2016, 74 McCleary 2018, 75 31 Kornblith 2002, 36 Townsley 2006, 37 Kemeny 2003, 69 Puts 2009, …”

Section: Sample Sourcementioning

confidence: 99%

“…Twenty-three subcategories of barriers were identified (Table 2) across the 12 observational studies. 31,[36][37][38][69][70][71][72][73][74][75][76] Using the ACT framework, barriers were categorized as system, provider, patient, and caregiver factors. Six (50%) of 12 observational studies 31,36,38,71,73,75 reported system barriers.…”

Section: Studies Assessing Barriers To Older Adult Participation In Cancer Clinical Trialsmentioning

confidence: 99%

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Older adult participation in cancer clinical trials: A systematic review of barriers and interventions

Sedrak

Freedman

Cohen

et al. 2020

CA A Cancer J Clinicians

279

200

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Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Sample Sourcementioning

confidence: 99%

Section: Studies Assessing Barriers To Older Adult Participation In Cancer Clinical Trialsmentioning

confidence: 99%

See 3 more Smart Citations

Older adult participation in cancer clinical trials: A systematic review of barriers and interventions

Sedrak

Freedman

Cohen

et al. 2020

CA A Cancer J Clinicians

279

200

View full text Add to dashboard Cite

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Letter to the editor

Narasimhulu

Akinhanmi

Balls-Berry

2019

Arch Gynecol Obstet

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How did we take care of our older cancer patients during the first COVID-19 wave? The French experience

et al. 2021

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Background The management of older cancer patients has been highly challenging for clinicians in a health-care system operating at maximum capacity during the COVID-19 pandemic. Patients and methods We analyzed data from 9 different institutions. The primary endpoint was to assess the prevalence of adapted patient care during the pandemic for elderly cancer patients. The secondary endpoint was to assess the incidence of hospitalization and mortality due to COVID-19. All patients were older than 65 years of age. Results We analyzed data from 332 outpatients’ case files between 9th of March and 30th of April 2020. The median age was 75 years (range: 65–101) and 53% were male. Because of the COVID-19 pandemic, more than half of the outpatients received modified patient care, defined as postponement or cancellation of surgery, irradiation scheme adapted, systemic treatment or the use of telemedicine. Among patients with localized cancer, 60% had a change in management strategy due to the pandemic. Changes in management strategy were made for 53% of patients at the metastatic stage. GCSF was used , in 83% of patients, increasing considerably in the context of the pandemic. Sixty-nine percent of physicians used telemedicine. In the final analysis, only one patient was hospitalized for COVID-19 infection. No deaths due to COVID-19 were reported in elderly cancer patients during this time period. Conclusion Our study is the first to assess modification of patient care in elderly cancer outpatients during an epidemic. With this unprecedented crisis, our objective is to protect our patients from infection via protective barrier measures and social distancing, but also to guarantee the continuity of cancer care without overexposing this fragile population. Physicians were able to adapt their practice and used new forms of management, like telemedicine.

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Participation of elderly gynecological cancer patients in clinical trials

Cited by 10 publications

References 27 publications

Older adult participation in cancer clinical trials: A systematic review of barriers and interventions

Older adult participation in cancer clinical trials: A systematic review of barriers and interventions

Letter to the editor

How did we take care of our older cancer patients during the first COVID-19 wave? The French experience

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