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.
Adult
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Breast Neoplasms
/ drug therapy
Decision Making
Decision Support Techniques
Female
Fertility Preservation
/ methods
Humans
Infertility, Female
/ chemically induced
Internet-Based Intervention
Randomized Controlled Trials as Topic
breast cancer
decision-making process
fertility preservation
informed choice
study protocol
web-based decision aid
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
10 02 2020
10 02 2020
Historique:
entrez:
13
2
2020
pubmed:
13
2
2020
medline:
16
2
2021
Statut:
epublish
Résumé
Chemotherapy 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. This 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. This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings. The ClinicalTrials.gov registry .(NCT03591848).
Identifiants
pubmed: 32047010
pii: bmjopen-2019-031739
doi: 10.1136/bmjopen-2019-031739
pmc: PMC7044978
doi:
Banques de données
ClinicalTrials.gov
['NCT03591848']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e031739Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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