Who Decides? Informed Consent for Cancer Patients in Mexico

2013 ◽  
pp. 237-249 ◽  
Author(s):  
Alonso Cerdán ◽  
Alejandro González-Arreola ◽  
Emma Verástegui
Keyword(s):  
Informed Consent ◽  
Cancer Patients

Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24121-e24121
Author(s):  
Celeste Cagnazzo ◽  
Veronica Franchina ◽  
Giuseppe Toscano ◽  
Franca Fagioli ◽  
Tindara Franchina ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Cancer Patients ◽  
Experimental Therapy ◽  
Average Score ◽  
Trial Participation ◽  
Primary Role ◽  
Fake News ◽  
Patient Awareness ◽  
The Impact

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

scholarly journals Risks of COVID‐19 for surgical cancer patients: The importance of the informed consent process

2020 ◽  
Vol 122 (4) ◽  
pp. 608-610 ◽  
Author(s):  
Alberto Julius Alves Wainstein ◽  
Ana Paula Drummond‐Lage ◽  
Reitan Ribeiro ◽  
Héber Salvador Castro Ribeiro ◽  
Rodrigo Nascimento Pinheiro ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cancer Patients ◽  
Informed Consent Process ◽  
Consent Process

Feasibility and effects of home parenteral nutrition (HPN) in cancer patients with or without migrant background.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24137-e24137
Author(s):  
Lena Rebekka Schickhaus ◽  
Anica Högner ◽  
Mario Lorenz ◽  
Prisca Sturm ◽  
Peter C. Thuss-Patience
Keyword(s):  
Informed Consent ◽  
Parenteral Nutrition ◽  
Cancer Patients ◽  
Ideal Point ◽  
Patient Characteristics ◽  
Nutrition Support ◽  
Nutrition Status ◽  
Migrant Background ◽  
Significant Difference ◽  
Eortc Qlq

e24137 Background: Parenteral nutrition is used in cancer patients (pts) requiring intensive nutrition support due to insufficient dietary intake and consuming tumor disease. As there is no data of HPN in pts with migrant background (MB), this observational study examined viability of HPN, influence on QoL and nutrition status of cancer pts with and without MB. Methods: Eligibility included ECOG ≥ 1, life expectancy ≥ 4 weeks, first time HPN for at least 28 days and written informed consent. Migrant background status and patient characteristics were assessed at baseline. At day 1 (baseline), day 14 and day 28 validated questionnaires assessed QoL, nutrition status (EORTC-QLQ-C15-PAL, Subjective global assessment (SGA)), as well as feasibility and complications of HPN. Additionally, bioimpedance analysis, BMI and weight were measured to evaluate response of HPN. Results: Between Mai 2015 and November 2019, 68 pts were included, 17 of them with MB. Tumor entities were gastric (n = 41), esophageal (n = 20) and other (n = 7), treated in a curative (n = 14) or palliative (n = 54) concept. Overall, 40 pts were able to continue HPN until day 14, 26 pts until day 28. 42 pts left study due to death (1 with MB/8 overall), worsening of general condition (3/15), dietary improvement (1/2), change of supplier (1/5), informed consent withdrawal (0/1) and lost to follow up (2/11). Global QoL in all pts was stable from baseline to d14 (n = 36; 36.6 to 40.3), whereas QoL in pts with MB deteriorated (n = 9; 37.0 to 27.8). From baseline to d28, QoL in all pts improved (n = 23; 38.4 to 47.8) and in pts with MB QoL was stable (n = 7; 40.5 to 42.9). Medical problems associated with HPN occurred in 4/11 pts with MB (36%) and 11/37 pts without MB (30%), respectively. The majority of pts reported about HPN-associated organizational complications, whereas there is no significant difference of pts with MB (6/10) and without MB (20/38). SGA improvement was observed in all pts regardless of MB. During the course of HPN, there was no significant change in body weight and BMI in all pts, independent from MB. Conclusions: Overall, 59% of pts received HPN for 14 days, only 38% of pts for 28 days. Discontinuation was mainly due to disease progression. Feasibility and organizational problems did not affect duration of HPN. Assessing HPN prospectively shows, that defining the ideal point to start HPN appears to be essential for response to HPN. In our study, migrant background is not associated with a major difference in incidence of complications, viability, benefit or duration of HPN.

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