Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials

Hlubocky, Fay J.; Kass, Nancy E.; Roter, Debra; Larson, Susan; Wroblewski, Kristen; Sugarman, Jeremy; Daugherty, Christopher K.

doi:10.1200/jop.18.00028

Cited by 17 publications

(16 citation statements)

References 52 publications

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“…Table 1 shows that eleven quantitative [16][17][18][19][20][21][22][23][24][25][26], five qualitative [27][28][29][30][31], and no mixed-method studies were included. Most studies were conducted in the USA (n = 12) [16,17,[19][20][21]23,24,26,27,[29][30][31], two in the UK [18,22], one in the Netherlands [25] and one in Japan [28]. Seven studies were conducted between 2000 and 2009 [16,17,20,22,23,26,31], and nine from 2010 onwards [18,19,21,24,25,[27][28][29][30].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Most studies were conducted in the USA (n = 12) [16,17,[19][20][21]23,24,26,27,[29][30][31], two in the UK [18,22], one in the Netherlands [25] and one in Japan [28]. Seven studies were conducted between 2000 and 2009 [16,17,20,22,23,26,31], and nine from 2010 onwards [18,19,21,24,25,[27][28][29][30]. Eleven studies focused only on phase I clinical trials [16,[18][19][20][21]23,[25][26][27][28][29], four studies on phase I/II clinical trials [17,22,30,31] and one study on phase I, II and III clinical trials [24].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Seven studies were conducted between 2000 and 2009 [16,17,20,22,23,26,31], and nine from 2010 onwards [18,19,21,24,25,[27][28][29][30]. Eleven studies focused only on phase I clinical trials [16,[18][19][20][21]23,[25][26][27][28][29], four studies on phase I/II clinical trials [17,22,30,31] and one study on phase I, II and III clinical trials [24]. For the latter, we only included the results for phase I and II clinical trials.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…The remaining 12 studies focused on eligible patients with advanced cancer for trial participation in general. Two studies also included oncologists or caregivers [21,27]. With regards to the timing in patients' decision-making process, 10 studies were conducted on patients after they showed interest or decided to participate in a trial, but before (or very shortly) after trial initiation [16,20,[22][23][24]26,[28][29][30][31].…”

Section: Study Characteristicsmentioning

confidence: 99%

See 3 more Smart Citations

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Lent

Jabbarian

Gurp

et al. 2021

Cancer Treatment Reviews

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Background: For many patients with advanced cancer, the decision whether to participate in early phase clinical trials or not is complex. The decision-making process requires an in-depth discussion of patient values. We therefore aimed to synthesize and describe patient values that may affect early phase clinical trial participation. Methods: We conducted a systematic search in seven electronic databases on patient values in relation to patients' decisions to participate in early phase clinical cancer trials. Results: From 3072 retrieved articles, eleven quantitative and five qualitative studies fulfilled our inclusion criteria. We extracted ten patient values that can contribute to patients' decisions. Overall, patients who seek trial participation usually report hope, trust, quantity of life, altruism, perseverance, faith and/or risk tolerance as important values. Quality of life and humanity are main values of patients who refuse trial participation. Autonomy and social adherence can be reported by both trial seekers or refusers, dependent upon how they are manifested in a patient. Conclusions:We identified patient values that frequently play a role in the decision-making process. In the setting of discussing early phase clinical trial participation with patients, healthcare professionals need to be aware of these values. This analysis supports the importance of individual exploration of values. Patients that become aware of their values, e.g. by means of interventions focused on clarifying their values, could feel more empowered to choose. Subsequently, healthcare professionals could improve their support in a patients' decision-making process and reduce the chance of decisional conflict.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Lent

Jabbarian

Gurp

et al. 2021

Cancer Treatment Reviews

View full text Add to dashboard Cite

show abstract

“…When asked about the LE modules, a surprising majority of patients agreed with the statement ''my doctor had already discussed most of this information with me.'' With rare exception, 45 most audiorecording studies have found explicit prognostic discussions to be absent from most oncology consultations and subsequent encounters. 14,17,46e48 Furthermore, vague prognostic statements (e.g., chemotherapy may ''buy you more time'') are shared more commonly than numerical estimates.…”

Section: Discussionmentioning

confidence: 99%

The Effect of Disclosing Life Expectancy Information on Patients' Prognostic Understanding: Secondary Outcomes From a Multicenter Randomized Trial of a Palliative Chemotherapy Educational Intervention

Enzinger

Uno

McCleary

et al. 2021

Journal of Pain and Symptom Management

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Are we undermining the value of palliative care through advanced cancer clinical trial consent language?

Umaretiya

Rubin

Snaman

et al. 2021

Cancer

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Informed consent forms for advanced oncology clinical trials present the following as an alternative to participation: You may choose to get comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems, and other problems caused by the cancer.We believe that this framing undermines the many advances in palliative care over the past 3 decades, sends unintended messages, and is a disservice to the patients and families that we serve. We found language offering variations of comfort care or palliative care as an alternative to trial participation in both pediatric and adult oncology consent forms across multiple institutions and clinical trials. This language appears to be unique to informed consents in oncology, as these terms were not included as alternatives in consents across other disease groups. The incorporation of palliative care into the informed consent form as an alternative to trial participation stems from templated language from regulatory bodies, including the National Cancer Institute. 1 Although the breadth of symptom support described is accurate, labeling the nontreatment path in this way misrepresents palliative care. These required and templated forms equate palliative care to comfort care, a phrase that is nebulous and poorly defined, and propagate language that lacks clarity about the types of care that patients and families may want to prioritize and/or avoid.Informed consent forms are required in clinical research to communicate the purpose of the study, risks and benefits of participation, and treatment alternatives. 2 Informed consent is a process and includes both written documentation and conversations between providers and patients. The disclosure of alternative treatments during this process is a federal legal and regulatory requirement. 3 However, the inclusion of palliative care among the listed alternatives to participation in an advanced cancer clinical trial is problematic. As described by the World Health Organization, palliative care aims to improve the quality of life for seriously ill patients and families and is applicable early in the course of illness in conjunction with life-prolonging therapies. 4 Palliative care is an approach to care; models have been created to distinguish primary palliative care, which includes communication and symptom management skills, from specialty palliative care, which encompasses advanced skills and training in symptom management, complex psychosocial issues, and communication. 5 Although informed consents for advanced cancer trials may be an appropriate time to introduce palliative care, we believe that doing so in this manner raises 2 key issues. First, presenting palliative care as an alternative to cancer-directed therapy suggests that the two cannot occur simultaneously: patients and families must choose to treat their cancer or choose to be comfortable. Second, informed consents may be a patient or family's first introduction to palliative care, and equating it to comfort care in this setti...

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Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials

Abstract: Many oncologists provide incomplete disclosures about phase I trials to ACPs. When disclosure of certain elements of IC occurs, it seems to be associated with better recall, especially with regard to the research purpose of phase I trials.

Cited by 17 publications

References 52 publications

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

The Effect of Disclosing Life Expectancy Information on Patients' Prognostic Understanding: Secondary Outcomes From a Multicenter Randomized Trial of a Palliative Chemotherapy Educational Intervention

Are we undermining the value of palliative care through advanced cancer clinical trial consent language?

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