At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials

Borno, Hala; Zhang, Li; Siegel, Adam; Chang, Emily; Ryan, Charles J.

doi:10.1634/theoncologist.2017-0628

Cited by 87 publications

(82 citation statements)

References 18 publications

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“…Overall, the results of the current study add to the growing body of literature characterizing the influence of contextual‐level SES on outcomes among men with prostate cancer . In prior research, the burden of travel has been shown to affect the receipt of medical care, and specifically cancer care . Because individuals diagnosed in rural settings were more likely to receive surgical ADT, these results support the idea that travel burden may affect cancer treatment plans, even in individuals with advanced disease.…”

Section: Discussionsupporting

confidence: 74%

“…33 In prior research, the burden of travel has been shown to affect the receipt of medical care, 34 and specifically cancer care. [35][36][37] Because individuals diagnosed in rural settings were more likely to receive surgical ADT, these results support the idea that travel burden may affect cancer treatment plans, even in individuals with advanced disease. These data highlight the need to clarify whether receipt of surgical ADT among patients from lower neighborhood SES areas was driven by patient preference, physician bias, or cost.…”

Section: Discussionsupporting

confidence: 54%

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Differential use of medical versus surgical androgen deprivation therapy for patients with metastatic prostate cancer

Borno

Lichtensztajn

Gomez

et al. 2018

Cancer

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Background Surgical and medical androgen deprivation therapy (ADT) strategies are comparable in their ability to suppress serum testosterone levels as treatment in patients with metastatic prostate cancer but differ with regard to cost and impact on quality of life. Medical ADT is associated with better long‐term quality of life due to the flexibility of possible therapy interruption but comes with a higher cumulative cost. In the current study, the authors examined whether surgical ADT (ie, bilateral orchiectomy) was used differentially by race/ethnicity and other social factors. Methods The authors identified patients with metastatic disease at the time of diagnosis through the California Cancer Registry. The association between race/ethnicity and receipt of surgical ADT was modeled using multivariable Firth logistic regression adjusting for age, Gleason score, prostate‐specific antigen level, clinical tumor and lymph node classification, neighborhood socioeconomic status (SES), insurance, marital status, comorbidities, initial treatment (radiotherapy, chemotherapy), location of care, rural/urban area of residence, and year of diagnosis. Results The authors examined a total of 10,675 patients with metastatic prostate cancer, 11.4% of whom were non‐Hispanic black, 8.4% of whom were Asian/Pacific Islander, 18.5% of whom were Hispanic/Latino, and 60.5% of whom were non‐Hispanic white. In the multivariable model, patients found to be more likely to receive surgical ADT were Hispanic/Latino (odds ratio [OR], 1.32; 95% confidence interval [95% CI], 1.01‐1.72), were from a low neighborhood SES (OR, 1.96; 95% CI, 1.34‐2.89) or rural area (OR, 1.49; 95% CI, 1.15‐1.92), and had Medicaid/public insurance (OR, 2.21; 95% CI, 1.58‐3.10). Patients with military/Veterans Affairs insurance were significantly less likely to receive surgical ADT compared with patients with private insurance (OR, 0.34; 95% CI, 0.13‐0.88). Conclusions Race/ethnicity, neighborhood SES, and insurance status appear to be significantly associated with receipt of surgical ADT. Future research will need to characterize other differences in initial treatments among men with advanced prostate cancer based on race/ethnicity and aim to better understand what factors drive the association between surgical ADT among men of Hispanic origin or those from areas with low neighborhood SES.

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Section: Discussionsupporting

confidence: 74%

Section: Discussionsupporting

confidence: 54%

Differential use of medical versus surgical androgen deprivation therapy for patients with metastatic prostate cancer

Borno

Lichtensztajn

Gomez

et al. 2018

Cancer

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“…It has previously been demonstrated that the burden of travel for clinical trials is highest for low-income patients, and this provides a possible explanation for why more affluent patients were more likely to be recruited to trials in this series. 27 In multivariate analyses, White patients were more likely to enroll in MDS trials. Racial disparities are a pervasive feature in clinical trial recruitment and may affect the generalizability of trial findings and also contribute to the worsening of health outcomes and higher mortality experienced by minority populations.…”

Section: Discussionmentioning

confidence: 99%

Low participation rates and disparities in participation in interventional clinical trials for myelodysplastic syndromes

Brierley

Zabor

Komrokji

et al. 2020

Cancer

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BACKGROUND: The development of novel therapies for the myelodysplastic syndromes (MDS) is hampered by inadequate trial recruitment. Factors contributing to low trial accrual are incompletely understood. METHODS: This study analyzed a pooled patient database from institutions of the US MDS Clinical Research Consortium to compare the characteristics of participants in interventional trials with those of patients who did not enroll in a trial. RESULTS: Data were identified for 1919 patients with MDS, and 449 of these patients (23%) participated in an interventional clinical trial. The median age of all patients was 68 years, and 64% were male. Patients who participated in trials were significantly younger than nonparticipants (P = .014), and men were more likely to participate in a trial (71% of trial participants were male, whereas 61% of nonparticipants were; P < .001). Race and ethnicity were not associated with trial enrollment. Patients in more affluent ZIP codes had a higher participation rate (P < .001). Patients with intermediate-and high-risk disease according to the revised International Prognostic Scoring System were overrepresented (P = .004), and trial participants less frequently had treatment-related disease (P < .001). In multivariable analyses, participation in a clinical trial was associated with a reduced hazard of death (P = .004). Even at large referral centers, only a minority of patients with MDS enrolled in interventional trials. CONCLUSIONS: Restrictive trial eligibility criteria that exclude patients with MDS on account of age, comorbidities, or a history of another cancer are limit enrollment of MDS patients to clinical trials. Gaining insight into the barriers to trial accrual may help investigators and study sponsors to design trials that will accrue more rapidly and augment treatment options for patients with MDS.

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“…For instance, O'Leary and colleagues showed that the median number of items collected per participant in a sample of cancer RCTs was 599 (range 186 to 1035), but only 18% of the data collected was actually used and reported in the resulting articles [46]. Similarly, a retrospective study of patient travel burden in cancer clinical trials using a Google Maps calculator showed that the median unidirectional distance traveled from home to the study site was 40 km (interquartile range 17.7 to 120.7) [51]. The benefits of trial participation identified in this study should also be considered for the planning and conducting of future research although it is important to acknowledge that some factors (e.g., completion of questionnaire) were considered as beneficial for some patients and burdensome by others.…”

Section: Toward Minimally Disruptive and Compassionate Clinical Researchmentioning

confidence: 99%

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

Naidoo

Nguyen

Ravaud

et al. 2020

BMC Med

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Background: Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. Methods: We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. Results: We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. Conclusions: Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. Review registration: PROSPERO CRD42018098994

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At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials

Cited by 87 publications

References 18 publications

Differential use of medical versus surgical androgen deprivation therapy for patients with metastatic prostate cancer

Differential use of medical versus surgical androgen deprivation therapy for patients with metastatic prostate cancer

Low participation rates and disparities in participation in interventional clinical trials for myelodysplastic syndromes

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

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