Can the Referring Surgeon Enhance Accrual of Breast Cancer Patients to Medical and Radiation Oncology Trials? The Enhance Study

Arnaout, Angel; Kuchuk, Iryna; Bouganim, Nathaniel; Pond, Gregory R.; Verma, Shailendra; Segal, Roanne; Dent, Susan; Gertler, S.; Song, Xinni; Kanji, Femina; Clemons, Mark

doi:10.3747/co.23.2394

Cited by 11 publications

(15 citation statements)

References 15 publications

(31 reference statements)

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“…In spite of prevailing ideals of patients’ self-management and shared decision-making, doctors continue to have a decisive role in determining their patients’ treatments. It is important to note that contrary to patients’ expectations, doctors do not always mention clinical trials [21], and, as our study indicates, will rarely mention existing opportunities for expanded access.…”

Section: Discussionmentioning

confidence: 59%

“…Still, our respondents were rather assertive with regard to their health, and may have differed in this respect from other Dutch patients. Studies have found, for instance, that most patients are not actively looking for non-standard treatment options such as clinical trials, and tend to follow recommendations by their doctors instead [21, 28, 29]. Our respondents were generally less passive, and more actively involved in searching for and decision-making regarding treatment options.…”

Section: Discussionmentioning

confidence: 85%

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What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands

Bunnik

Aarts

2019

BMC Med Ethics

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BackgroundPatients with unmet medical needs sometimes resort to non-standard treatment options, including the use of unapproved, investigational drugs in the context of clinical trials, compassionate use or named-patient programs. The views and experiences of patients with unmet medical needs regarding unapproved, investigational drugs have not yet been examined empirically.MethodsIn this qualitative study, exploratory interviews and focus groups were held with patients with chronic or life-threatening diseases (n = 39), about topics related to non-standard treatment options, such as the search for non-standard treatment options, patients’ views of the moral obligations of doctors, and the conditions under which they would or would not wish to use non-standard treatment options, including expanded access to unapproved, investigational drugs.ResultsRespondents had very little knowledge about and/or experience with existing opportunities for expanded access to investigational drugs, although some respondents were actively looking for non-standard treatment options. They had high expectations of their treating physicians, assuming them to be aware of non-standard treatment options, including clinical trials elsewhere and expanded access programs, and assuming that they would inform their patients about such options. Respondents carefully weighed the risks and potential benefits of pursuing expanded access, citing concerns related to the scientific evidence of the safety and efficacy of the drug, side effects, drug-drug interactions, and the maintaining of good quality of life. Respondents stressed the importance of education and assertiveness to obtain access to good-quality health care, and were willing to pay out of pocket for investigational drugs. Patients expressed concerns about equal access to new and/or non-standard treatment options.ConclusionWhen the end of a standard treatment trajectory comes into view, patients may prefer that treating physicians discuss non-standard treatment options with them, including opportunities for expanded access to unapproved, investigational drugs. Although our respondents had varying levels of understanding of expanded access programs, they seemed capable of making well-considered choices with regard to non-standard treatment options and had realistic expectations with regard to the safety and efficacy of such options. Dutch patients might be less likely to fall prey to false hope than often presumed.

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Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 85%

What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands

Bunnik

Aarts

2019

BMC Med Ethics

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“…Given that these novel agents will be added to a standard chemotherapy backbone, determining the optimal chemotherapy regimen should be regarded as a pressing research question. However, most physicians appeared to have minimal enthusiasm about the study overall, and developing a strategy to perform such a study would be challenging [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial)

et al. 2018

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IntroductionDespite the importance of chemotherapy in the treatment of early stage triple negative breast cancer (TNBC), no one optimal regimen has been identified. We conducted a pilot trial comparing outcomes for the three most commonly used chemotherapy regimens to assess the feasibility of conducting a larger definitive trial.MethodsUsing integrated consent, newly diagnosed TNBC patients were randomised to one of three standard regimens: dose-dense doxorubicin-cyclophosphamide then paclitaxel, doxorubicin-cyclophosphamide then weekly paclitaxel or 5-FU-epirubicin-cyclophosphamide then docetaxel. Feasibility endpoints included; physician engagement, accrual rates, physician compliance and patient satisfaction with the integrated consent model. Our anticipated pilot trial sample size was 35 randomised patients in one year.ResultsBetween August 30th, 2016 and January 31st 2017, 2 patients met eligibility and were randomised. A survey of 10 participating oncologists was performed to identify potential strategies to enhance accrual. Most investigators (9/10) believed that the best regimen for TNBC was unknown, and 4/10 felt this was a pressing clinical question. Physicians’ responses suggested that poor accrual was due to: a lack of interest in some study arms as oncologists already had a preferred regimen (4/10) and concerns about trial demands in busy clinics (3/10). The pilot feasibility endpoints were not met and the study was closed.ConclusionsDespite initial interest in the trial question and multiple investigators agreeing to approach patients, this trial failed to meet feasibility endpoints. The reasons for poor accrual were multiple and require further evaluation if this important patient-centred question is to be answered.Trial registrationClinicalTrials.gov NCT02688803.

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“…Physicians, on the other hand, may feel obliged to move forward with research, here, their personal evaluation of the research may also play an important role. 48,49 However, physicians may also encounter uncertainties regarding the object of research and may have difficulties explaining clinical research which can also affect informed consent consultations. 8 A more general concern is the conflict of interest at play when physicians are conducting research at the same time of caring for patients, making it easier for physicians to identify and recruit research subjects.…”

Section: Background: Ethical Considerations Of Oncology Patients' Resmentioning

confidence: 99%

Physicians’ communication patterns for motivating rectal cancer patients to biomarker research: Empirical insights and ethical issues

2018

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In clinical research-whether pharmaceutical, genetic or biomarker research-it is important to protect research participants' autonomy and to ensure or strengthen their control over health-related decisions. Empirical-ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. For this, a better understanding of recruitment, for which also the physicianpatient relationship plays an important role, is needed. Our aim is to ethically reflect communication processes by identifying patterns used by physicians to motivate patients' participation in clinical research and to assess whether patients also use these patterns in formulating their own research motivation. We conducted a secondary analysis with empirical data from a research project involving physicians and patients in a clinical research setting of a biomarker study for rectal cancer treatment. Our empirical data included observations of physician-patient consultations (n ¼ 54) and semi-structured interviews with patients (n ¼ 40). Overall, we collected 93 interviews. We found two dominant communication patterns, which physicians applied for motivating patients to take part in this research study. Some forms of these patterns tend to mislead patients' understanding, while others could justifiably be applied in this consultation setting without undermining patients' autonomy. This insight that the physician-patient communication has a strong influence on patients increases the importance to strengthen physicians' ethically acceptable communication patterns regarding research participation. We further suggest that there is a need for a critical reflection of the ethics committee's requirements for information regarding research participation.

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Can the Referring Surgeon Enhance Accrual of Breast Cancer Patients to Medical and Radiation Oncology Trials? The Enhance Study

Abstract: IntroductionThe accrual rate to clinical trials in oncology remains low. In this exploratory pilot study, we

Cited by 11 publications

References 15 publications

What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands

What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands

Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial)

Physicians’ communication patterns for motivating rectal cancer patients to biomarker research: Empirical insights and ethical issues

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