Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid

NCT05607849 | Not Yet Recruiting DMC

• 2 other identifiers: RC20_05322024-A00987-40
• Study Type: interventional
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website Discutons-mammo.fr DEDICACES project 1. DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.

Conditions

Breast Cancer

Keywords

Breast cancer screening; Organized screening; General practitioner; Randomized controlled trial; Shared medical decision-making; Decisional aid; Primary health care

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effectiveness of the discutons-mammo.fr DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.

  Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].

  2 months

Secondary Outcomes (5)

• Evaluation of the effect of the presentation of the discutons-mammo.fr tool on the intention to participate in OBCS.

  2 months

• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on the implementation of shared decision-making.

  2 months

• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on women's knowledge of OBCS.

  2 months

• Evaluation of the effect of the presentation of the discutons-mammo.fr DA tool on women's care pathways following an invitation to participate in OBCS.

  2 months

• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.

  2 months

Study Arms (2)

Decisional aid for organised cancer screening

EXPERIMENTAL

Women will receive a leaflet that presents the tool. The leaflet includes a link to access the tool, and encourages the person to consult their GP to initiate the shared decision-making process. GPs will receive a letter presenting the study that includes: a) information about shared decision-making and how to implement it; b) the letter that is sent to their patients, and c) a recommendation to implement shared decision-making with their patients.

Other: The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool.

Standard organised cancer screening

NO INTERVENTION

Women and their GPs will continue to carry out usual screening.

Interventions

The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool. OTHER

The leaflet will include a link to access the discutons-mammo.fr DA aid tool, and will inform women about shared decision-making. The GPs of women who are sent the leaflet will also be sent a letter encouraging shared decision-making. This material will be sent 3 months after women have received their breast cancer screening invitation letter. Data related to primary and secondary objectives will be collected by questionnaire from the 2 groups. The questionnaire will be sent 2 months after participants are informed about the tool.

Decisional aid for organised cancer screening

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- General practitioners (GPs):
• The following GPs will be included:
• \) Practicing in one of the French départements (administrative area) covered by the study.
• \- Women:
• The following women will be included:
• Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.

You may not qualify if:

• \- General practitioners (GPs) :
• The following GPs will be excluded:
• Those who do not have any patients invited for OBCS in the studied month;
• Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
• Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
• Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
• Those who are participating in the MyPEBS study (the only national study of OBCS at the time the present protocol was drawn up).
• Women:
• The following women will not be included:
• Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
• If their GP refuses to participate in the study; or,
• women under guardianship.
• The following women will be excluded:
• Those who object to the study in accordance with regulatory procedures issued by the Data Protection Officer (DPO),
• Those who do not respond within 1 month after the questionnaire has been sent.

Sponsors & Collaborators

• Nantes University Hospital: lead
• National Cancer Institute, France: collaborator
• Nantes University hospital, Research Department: collaborator

Related Publications (1)

• Hild S, Teigne D, Ferrat E, Banaszuk AS, Berquet K, Lebon A, Bataille E, Nanin F, Gaultier A, Rat C. Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol. Front Oncol. 2023 Apr 24;13:1128467. doi: 10.3389/fonc.2023.1128467. eCollection 2023.

  PMID: 37168386 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cédric Rat, M.D. PhD.

  Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France

  STUDY DIRECTOR

• Sandrine Hild, M.D.

  Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric Rat, M.D. PhD.

CONTACT

02 40 41 28 28; cedric.rat@univ-nantes.fr

Sandrine Hild, M.D.

CONTACT

sandrine.hild@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 7, 2022
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share