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Patients' reasoning regarding the decision to participate in clinical cancer trials : an interview study

Dellson, Pia LU ; Nilsson, Kerstin; Jernström, Helena LU and Carlsson, Christina LU (2018) In Trials 19(1).
Abstract

BACKGROUND: Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about participation. The inclusion process is complex, including both oral and written information about the trial. The process of patients' decision-making regarding clinical cancer trials has not yet been sufficiently studied. This interview study aims to explore the process of patients' reasoning regarding the decision to participate in a clinical cancer trial.

METHODS: The study is based on 27 individual face-to-face interviews with patients who had decided to participate in a clinical cancer trial. The interviews were... (More)

BACKGROUND: Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about participation. The inclusion process is complex, including both oral and written information about the trial. The process of patients' decision-making regarding clinical cancer trials has not yet been sufficiently studied. This interview study aims to explore the process of patients' reasoning regarding the decision to participate in a clinical cancer trial.

METHODS: The study is based on 27 individual face-to-face interviews with patients who had decided to participate in a clinical cancer trial. The interviews were audio-recorded and transcribed verbatim and then analysed using inductive content analysis.

RESULTS: Content analysis revealed 17 subthemes grouped into five themes: (1) an unhesitating decision to participate; (2) a decision based on flimsy grounds and guided by emotion; (3) feeling safe and secure with my decision; (4) faced with a choice versus what choice do I have? and (5) hoping for help while helping others. The decision to participate in a clinical cancer trial was often immediate and guided by emotions, based on a trusting relationship with healthcare personnel rather than on careful reading of written information. Palliative patients, in particular, sometimes had unrealistic beliefs about the effectiveness of the trial treatment.

CONCLUSIONS: It is vital that the decision to participate in a clinical cancer trial is preceded by an honest dialogue about possible positive and negative effects of the trial treatments, including other options such as supportive care in the palliative setting. Our findings also raise the questions of how important written information is for the decision-making process and also whether genuine informed consent is possible. To reach a higher degree of informed consent, it is most important that the oral information is given in a thorough and unbiased manner.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical cancer trial, Communication, Decision-making, Informed consent, Interviews, Patient experiences, Patient information, Qualitative study
in
Trials
volume
19
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85054053686
ISSN
1745-6215
DOI
10.1186/s13063-018-2916-9
language
English
LU publication?
yes
id
0bcc4344-2ef3-4c38-abf7-d85685adef67
date added to LUP
2018-10-10 14:31:33
date last changed
2019-02-20 11:30:52
@article{0bcc4344-2ef3-4c38-abf7-d85685adef67,
  abstract     = {<p>BACKGROUND: Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about participation. The inclusion process is complex, including both oral and written information about the trial. The process of patients' decision-making regarding clinical cancer trials has not yet been sufficiently studied. This interview study aims to explore the process of patients' reasoning regarding the decision to participate in a clinical cancer trial.</p><p>METHODS: The study is based on 27 individual face-to-face interviews with patients who had decided to participate in a clinical cancer trial. The interviews were audio-recorded and transcribed verbatim and then analysed using inductive content analysis.</p><p>RESULTS: Content analysis revealed 17 subthemes grouped into five themes: (1) an unhesitating decision to participate; (2) a decision based on flimsy grounds and guided by emotion; (3) feeling safe and secure with my decision; (4) faced with a choice versus what choice do I have? and (5) hoping for help while helping others. The decision to participate in a clinical cancer trial was often immediate and guided by emotions, based on a trusting relationship with healthcare personnel rather than on careful reading of written information. Palliative patients, in particular, sometimes had unrealistic beliefs about the effectiveness of the trial treatment.</p><p>CONCLUSIONS: It is vital that the decision to participate in a clinical cancer trial is preceded by an honest dialogue about possible positive and negative effects of the trial treatments, including other options such as supportive care in the palliative setting. Our findings also raise the questions of how important written information is for the decision-making process and also whether genuine informed consent is possible. To reach a higher degree of informed consent, it is most important that the oral information is given in a thorough and unbiased manner.</p>},
  articleno    = {528},
  author       = {Dellson, Pia and Nilsson, Kerstin and Jernström, Helena and Carlsson, Christina},
  issn         = {1745-6215},
  keyword      = {Clinical cancer trial,Communication,Decision-making,Informed consent,Interviews,Patient experiences,Patient information,Qualitative study},
  language     = {eng},
  month        = {09},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {Trials},
  title        = {Patients' reasoning regarding the decision to participate in clinical cancer trials : an interview study},
  url          = {http://dx.doi.org/10.1186/s13063-018-2916-9},
  volume       = {19},
  year         = {2018},
}