Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials

Reeder‐Hayes, Katherine E.; Roberts, Megan C.; Henderson, Gail E.; Dees, Elizabeth Claire

doi:10.1200/jop.2017.021303

Cited by 21 publications

(58 citation statements)

References 30 publications

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“…The trusting relationship between patient and professional meant that all consenting patients felt their doctor saw the clinical trial as the best treatment for them as an individual. This finding is consistent with other studies [11,25,40] which have identified trust as a central component to trial decision-making. Findings in our study clearly showed that doctors were aware that patients trusted them and felt burdened by this, though were perhaps not aware of the power they had to influence patients' decision making.…”

Section: Discussionsupporting

confidence: 93%

“…The quality and validity of informed consent is critical, but previous research asserts that understanding can be limited and patients often confuse trial care with standard care [9][10][11][12]. Many factors have been identified as impacting on patients' understanding, such as literacy [13], readability, complexity of consent forms and quality of explanations by the research team [14].…”

Section: Introductionmentioning

confidence: 99%

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Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent

et al. 2020

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Background Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging. Aim To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved. Methods In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process. Results ‘Nothing to lose’ was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the ‘only hope in the room’. The decision regarding participation was taken within a ‘trusting relationship’ that was important to both patients and professionals. Both were united in their ‘fight against cancer’. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model. Conclusion This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent

et al. 2020

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“…Unexpected and unrealistic views of patients on adverse effects of systemic treatment and surgical complications can result in decreased confidence in medical care, negative coping, and a deterioration in quality of life. It is well-known from phase I trials, that patients underestimate the potential toxicities that could result from oncological therapy (66). To improve awareness, recent efforts have focused on incorporating online information tools in oncology care.…”

Section: Discussionmentioning

confidence: 99%

COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis

et al. 2019

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Background: For the curative treatment of gastric cancer, several neoadjuvant, and adjuvant treatment-regimens are available which have shown to improve overall survival. No overview is available regarding toxicity and surgery related outcomes. Our aim was to construct a novel graphical method concerning adverse events (AEs) associated with multimodality treatment and perform a meta-analysis to compare different clinically relevant cytotoxic regimens with each other. Methods: The PubMed, EMBASE, CENTRAL, and ASCO/ESMO databases were searched up to May 2019 for randomized controlled trials investigating curative treatment regimens for gastric cancer. To construct single and bidirectional bar-charts (COMplots), grade 1–2 and grade 3–5 AEs were extracted per cytotoxic regimen. For surgery-related outcomes a pre-specified set of complications was used. Thereafter, treatment-arms comparing the same regimens were combined in a single-arm random-effects meta-analysis and pooled-proportions were calculated with 95% confidence-intervals. Comparative meta-analyses were performed based on clinical relevance and compound similarity. Results: In total 16 RCTs ( n = 4,526 patients) were included investigating pre-operative-therapy and 39 RCTs investigating adjuvant-therapy ( n = 13,732 patients). Pre-operative COMplots were created for among others; 5-fluorouracil/leucovorin-oxaliplatin-docetaxel (FLOT), epirubicin-cisplatin-fluoropyrimidine (ECF), cisplatin-fluoropyrimidine (CF), and oxaliplatin-fluoropyrimidine (FOx). Pre-operative FLOT showed a minor increase in grade 1–2 and grade 3–4 AEs compared to pre-operative ECF, CF, and FOx. A pooled analysis of patients who had received pre-operative therapy compared to patients who underwent direct surgery did not reveal any significant difference in surgery related morbidity/mortality. When we compared three commonly used adjuvant regimens; S-1 had the lowest amount of grade 3–4 AEs compared to capecitabine with oxaliplatin (CAPOX) and 5-FU with radiotherapy (5-FU+RT). Conclusion: COMplot provides a novel tool to visualize and compare treatment related AEs for gastric cancer. Based on our comparisons, pre-operative FLOT had a manageable toxicity profile compared to other pre-operative doublet or triplet regimens. We found no evidence indicating surgical outcomes might be hampered by pre-operative therapy. Adjuvant S-1 had a more favorable toxicity profile compared to CAPOX and 5-FU+RT.

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“…Any uncertainty of benefit, likely adverse effects, and estimated prognosis should be clearly communicated and understood by the patients before any decisions are made for proceeding to treatment. [ 9 ] Hence, it is not just a question of clinical effectiveness, but of balancing the potential benefits and harms of different available options to find what is most appropriate for the individual, and sometimes clinical practice guidelines not that effective in communication with patients. [ 10 ]…”

Section: R Esultsmentioning

confidence: 99%

Shared decision-making and medicolegal aspects: Delivering high-quality cancer care in India

Doval¹,

Kumar²,

Talwar³

et al. 2020

Indian J Palliat Care

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It is often difficult for people with cancer to make decisions for their care. The aim of this review is to understand the importance of shared decisionmaking (SDM) in Indian clinical scenario and identify the gaps when compared to practices in the Western world. A systematic search (2000-2019) was executed in Medline and Google Scholar using predefined keywords. Of the approximate 400 articles retrieved, 43 articles (Indian: 5; Western: 38) were selected for literature review. Literature review revealed the paucity of information on SDM in India compared to the Western world data. This may contribute to patientreported physical or psychological harms, life disruptions, or unnecessary financial costs. Western world data demonstrate the involvement and sharing of information by both patient and physician, collective efforts of the two to build consensus for preferred treatment. In India, involvement of patients in the planning for treatment is largely limited to tertiary care centers, academic institutes, or only when the cost of therapy is high. In addition, cultural beliefs and prejudices impact the extent of participation and engagement of a patient in disease management. Communication failures have been found to strongly correlate with the medicolegal malpractice litigations. Research is needed to explore ways to how to incorporate SDM into routine oncology practice. India has a high unmet need towards SDM in diagnosis and treatment of cancer. Physicians need to involve patients or their immediate family members in decision making, to make it a patient-centric approach as well. SDM enforces to avoid uninformed decisionmaking or a lack of trust in the treating physician's knowledge and skills. Physician and patient education, development of tools and guiding policies, widespread implementation, and periodic assessments may advance the practice of SDM.

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Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials

Cited by 21 publications

References 30 publications

Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent

Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent

COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis

Shared decision-making and medicolegal aspects: Delivering high-quality cancer care in India

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