Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation

Godskesen, Tove; Nygren, Peter; Nordin, Karin; Hansson, Mats; Kihlbom, Ulrik

doi:10.1007/s00520-013-1891-7

Cited by 56 publications

(124 citation statements)

References 23 publications

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“…Some relatives also expressed that they felt like they had no choice . Acceptors believed they would make the same decision again , they felt that trial participation gave them the best treatment available , and they felt that trial participation was an easy decision . Patients knew that they had options, and being able to make their own decisions was very important, even though options were limited .…”

Section: Resultsmentioning

confidence: 99%

“…Nevertheless, other studies revealed that the information was unclear for quite a few patients. Misunderstanding the principle of allocation, confusion about trial setup, potentially equal risks and benefits and trial purpose were common problems.…”

Section: Resultsmentioning

confidence: 99%

“…Some patients preferred to make the decision on their own, while some made the decision in dialogue with their relatives . For some patients, their relatives’ reactions towards the trials meant more than the experiences with past treatment and the doctors’ positive explanation of trial participation .…”

Section: Resultsmentioning

confidence: 99%

“…Consequently, clinical trials equal hope for the patients , and, for many patients, treatment becomes the meaning in life, a way to try to live and a hope to the end . In patients’ experiences, hope and fear seem to be closely connected when making treatment decisions . In the context of whole person care, healing can be described as a transition from anxiety and suffering towards a sense of integrity, completeness and inner peace.…”

Section: Discussionmentioning

confidence: 99%

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What matters in clinical trial decision‐making: a systematic review of interviews exploring cancer patients’ experiences

Gregersen

Birkelund

Wolderslund

et al. 2019

Scandinavian Caring Sciences

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Background Being diagnosed with cancer is an existential challenge and involves difficult treatment decisions, including treatment in clinical trials. Therapy for advanced cancer is potentially life‐prolonging and only rarely cures advanced cancer, which often renders these patients in a special situation where dealing with end of life, hope and meaning, become an important part of life. Many existing reviews include both patients with advanced cancer and patients undergoing adjuvant cancer treatment, and there is a lack of reviews with consistent study designs and methods. Aim To systematically review and thematically synthesise the experiences of patients and relatives when they have to decide whether or not to participate in a clinical oncology trial and to provide knowledge about the decision‐making process. Method A qualitative systematic literature review was conducted based on methods for thematic synthesis by Thomas and Hardens. Results Eleven full‐text articles were included in this study. Six descriptive themes appeared and were grouped under two analytical themes: Individualised decisions and Hope and existential matters, which, through discussion, developed into the synthesis of What matters in treatment‐related decisions close to the end of life? This review has shown that existential matters are important in the decision‐making and that addressing these might be of great importance in medical decision‐making, whether it concerns the existential matters of the patients, of their relatives or of the health care professionals. Conclusion This review points to existential issues as important contributors in making decisions about treatment. It can be beneficial if health care professionals address the role of existential matters in patients’ decision‐making in terms of clinical trial participation and involve the relatives more directly to increase individualised decisions. Future research should include the health care professionals’ experiences when going in depth with decision‐making, with a focus on the existential matters and uncertainties of the health care professionals.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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What matters in clinical trial decision‐making: a systematic review of interviews exploring cancer patients’ experiences

Gregersen

Birkelund

Wolderslund

et al. 2019

Scandinavian Caring Sciences

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“…The rights, safety and well‐being of the participants are protected by the international, ethical and scientific principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP), which also stresses the necessity of obtaining the participants’ voluntary informed consent prior to participation in the trial (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ). A 2013 Swedish study directed attention towards ethical concerns regarding cancer patients’ participation in phase I trials because patients in the study often overestimated the benefits and underestimated, or failed to understand, the risks and possible side effects related to treatment in the trial (Godskesen, Nygren, Nordin, Hansson, & Kihlbom, ). As a result, it is essential to examine patients’ perceptions to determine which factors may influence their decision to participate in a clinical drug trial.…”

Section: Introductionmentioning

confidence: 99%

Cancer patients’ perceptions of factors influencing their decisions on participation in clinical drug trials: A qualitative meta‐synthesis

Nielsen

Berthelsen

2019

Journal of Clinical Nursing

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Aims and objectives To examine cancer patients’ perceptions of factors that may influence their decisions on participating in phase I–III clinical drug trials. Background The number of cancer participants in clinical drug trials has increased rapidly in Denmark in recent years. The rights, safety and well‐being of patients considering participation are protected by the international, ethical and scientific principles. A meta‐synthesis was conducted to enable health professionals to support cancer patients who are considering trial participation in accordance with the above principles. Design Meta‐synthesis. Methods A qualitative meta‐synthesis, as described by Sandelowski and Barroso, was conducted based on a literature search in PubMed, CINAHL, EMBASE and PsycINFO. Nine reports were found eligible and were included. The PRISMA checklist was used. Results A framework was developed, and patients’ perceptions of the factors influencing their decisions were identified, namely patients’ perceptions of their relatives, the physician, the hope of therapeutic benefit, altruism, having other options and living with cancer. Conclusions This study shows that cancer patients’ decisions on participation in clinical drug trials are influenced by their perceptions of trust towards the physician, their relatives’ attitudes and the consequences participation might have for their families. Patients are motivated to participate due to the hope of therapeutic benefit and for altruistic reasons. The factors influencing their decisions to participate include a cost‐benefit consideration, which in turn may be subject to the patient's perception of having other options available besides participation. This may be related to the patient's attitude towards living with cancer, and the decision can be a way of trying to cope with the psychological aspects of living with cancer. Relevance to clinical practice The results of this meta‐synthesis offer insight into patients’ perceptions of what may influence their decisions, and they enable health professionals to support patients making such decisions.

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Therapeutic Misperceptions in Early‐Phase Cancer Trials: From Categorical to Continuous

Sisk

Kodish

2018

IRB: Ethics & Human Research

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Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation

Cited by 56 publications

References 23 publications

What matters in clinical trial decision‐making: a systematic review of interviews exploring cancer patients’ experiences

What matters in clinical trial decision‐making: a systematic review of interviews exploring cancer patients’ experiences

Cancer patients’ perceptions of factors influencing their decisions on participation in clinical drug trials: A qualitative meta‐synthesis

Therapeutic Misperceptions in Early‐Phase Cancer Trials: From Categorical to Continuous

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