Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial

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).

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Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening

BMJ Open ◽

10.1136/bmjopen-2018-024136 ◽

2018 ◽

Vol 8 (11) ◽

pp. e024136 ◽

Cited By ~ 5

Author(s):

Annie S Anderson ◽

Angela Mary Craigie ◽

Stephanie Gallant ◽

Chloe McAdam ◽

E Jane Macaskill ◽

...

Keyword(s):

Breast Cancer ◽

Physical Activity ◽

Cost Effectiveness ◽

Cancer Screening ◽

Randomised Controlled Trial ◽

Weight Management ◽

Breast Cancer Screening ◽

Controlled Trial ◽

Behaviour Change Techniques ◽

Randomised Controlled

IntroductionIn Scotland, the incidence of breast cancer is predicted to rise significantly in the next few decades and while there are measures to support reductions in morbidity and mortality, the breast cancer community is currently exploring preventative opportunities including supporting weight management programmes in postmenopausal women. This study aims to assess the effectiveness and cost-effectiveness of a theory-based, community delivered, minimal contact, weight management (diet, physical activity and behaviour change techniques) programme (ActWELL) in women with a body mass index (BMI) >25 kg/m2 attending routine breast cancer screening appointments.Methods and analysisThe study will be a four-centre, 1:1 parallel group randomised controlled trial of a 12-month weight management intervention initiated in breast cancer screening centres, delivered by trained Breast Cancer Now lifestyle coaches in community settings. The intervention programme involves two intervention meetings with coaches plus (up to) nine telephone contacts over 12 months. The programme will focus on personalised diet (including alcoholic and sugary drinks) and physical activity habits. Behaviour change techniques include self-monitoring, goal setting, implementation intentions, action and coping plans. The study has a sample size of 414 women with a BMI >25 kg/m2 attending routine National Health Service breast cancer screening appointments. Measures will be taken at baseline, 12 weeks and at 12-month follow-up, complemented by qualitative interviews exploring perceived acceptability and impact on habitual behaviours. The two co-primary outcomes are mean change in measured body weight and change in physical activity between groups to 12 months. Secondary outcomes are changes in eating habits, alcohol intake, sedentary time, quality of life, waist circumference, lipid, haemoglobin A1c and insulin profiles, blood pressure and cost-effectiveness of the intervention.Ethics and disseminationThe protocol has been approved by East of Scotland Research Ethics Committee (17/ES/0073). All participants provide written informed consent. Dissemination will be through peer-reviewed publication and conference presentations.Trial registration numberISRCTN11057518; Pre-results.

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