scholarly journals Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial

2014 ◽  
Vol 111 (1) ◽  
pp. 1-7 ◽  
Author(s):  
I Juraskova ◽  
P Butow ◽  
C Bonner ◽  
M L Bell ◽  
A B Smith ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Decision Making ◽  
Randomised Controlled Trial ◽  
Decision Aid ◽  
Controlled Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Breast Cancer Prevention Trial ◽  
Randomised Controlled

scholarly journals Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031739
Author(s):  
Alexandra Benoit ◽  
Michael Grynberg ◽  
Rémy Morello ◽  
Nathalie Sermondade ◽  
Guillaume Grandazzi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Randomised Controlled Trial ◽  
Fertility Preservation ◽  
Decision Aid ◽  
Controlled Trial ◽  
Informed Choice ◽  
Phase Iii ◽  
Web Based ◽  
Randomised Controlled

IntroductionChemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation.Methods and analysisThis study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients.Ethics and disseminationThis study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings.Trial registration numberThe ClinicalTrials.gov registry .(NCT03591848).

scholarly journals Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial

2021 ◽  
pp. 146531252110242
Author(s):  
Peter Knapp ◽  
Nicky Mandall ◽  
Wendy Hulse ◽  
Jenny Roche ◽  
Thirimon Moe-Byrne ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Multimedia Information ◽  
Information Exchange ◽  
Controlled Trial ◽  
Trial Participation ◽  
Free Text ◽  
The Difference ◽  
Randomised Controlled ◽  
The Uk

Objective: To compare two methods of providing information about the Bone Anchored Maxillary Protraction (BAMP) trial: standard printed information and multimedia websites, for their quality and ease of understanding, and impact on decision-making. Design: Randomised controlled trial. Setting: Orthodontic outpatient clinic in the UK. Methods: Participants were 109 adolescents (aged 11–14 years) attending for orthodontic treatment. While awaiting treatment they were asked to imagine being recruited to the BAMP clinical trial. They were individually randomised to receive the printed or the multimedia website information (comprising text, animations and ‘talking head’ videos). After reading or viewing the information, they completed a 9-item Likert scale Decision-Making Questionnaire (DMQ) (score range 0–36) plus three free-text questions on their evaluation of the information. Results: A total of 104 participants completed the questionnaire. Mean total DMQ scores were higher (more positive) in the website group (28.1 vs. 27.0), although the difference was small and not statistically significant ( P = 0.20). Analysis of individual questionnaire items showed two statistically significant differences: the website information had higher ratings on ‘easy to understand’ (Z = 3.03; P = 0.003) and ‘confidence in decision-making’ (Z = 2.00; P = 0.044). On the three free-text questions, more positive and fewer negative comments were made about the websites than the printed information. Conclusion: In this hypothetical trial setting, adolescent patients found that trial information conveyed on a multimedia website was easier to understand and made them more confident in their decision about trial participation. Their subjective evaluations of the website were also more positive and less negative than about the printed information. Multimedia information has the potential to increase the quality of engagement and information exchange when seeking consent for research.

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