Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).

Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.

Decision aid for breast cancer screening

Standard leaflet

Montserrat Rué, PhD

The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.

The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.

Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making

The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.

Hospital del Mar

Canary Islands Health Service

Institut Català d'Oncologia

Institut de Recerca Biomèdica de Lleida

Professor

Decision aid

Heather Davey, B.Psych, MPH

Nehmat Houssami, MBBS, PhD

Erin Mathieu, B.Ed, MPH

Andrew Page, BA (Hons)

Richard Taylor, MBBS, PhD

Sian Smith, BSc (Hons)

Phyllis Butow, MPH, PhD

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Australian Screening Mammography Decision Aid Trial (ASMDAT)

An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.

University of Sydney

The intervention arm will receive full information on the risks and benefits of mammography through:

1. Decision aid
2. YouTube video
3. Group information session

Standard information leaflet for breast screening from Cancer Care Ontario

Patients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start.

Full information

Dee Mangin, MBChB, DPH, FRNZCGP

Jessica Langevin, MPH

Dee Mangin, MB ChB

Dale Guenter, MD

Cathy Risdon, MD

To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.

1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.

Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)

Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Knowledge will be measured using the Multidimensional Measure of Informed Choice (MMIC).

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Attitudes will be measured using the Multidimensional Measure of Informed Choice (MMIC).

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Intention to screen will be measured using a 5-point Likert scale.

SURE (Decisional Conflict Scale- SURE Test for clinical practice)

Women will be asked about their anxiety towards participating in breast screening after reading their information pamphlet using a 4-point Likert scale.

Women will be asked to assess their perception of the strength of the recommendation that their health care provider makes with respect to breast screening.

Women will be asked to describe the information that was relevant to their individual decision making process.

Data on a women's decision to undergo screening through mammography will be obtained from patient's electronic medical record.

Clinician staff will be asked to list the five best things and five worst things about the implementation of a patient focused decision aid.

Multiple choice question on knowledge of breast cancer mortality reduction and over-diagnosis.

David Braley and Nancy Gordon Chair in Family Medicine

McMaster University

Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.

Decision-aid

Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Standard information

The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.

Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health.

Decision-aid on Breast Cancer Screening

New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice

Knowledge will be measured using a questionnaire structured in 13 questions with multiple choice answers, with 2 to 4 options. Ten questions will be qualitative and 3 will be numerical. A score of 8 out of 13 (about 60%) or higher would be considered "adequate knowledge".

Attitude will be measured through a scale of 6 items with 5 response options from 1 to 5, with a total score from 6 to 30. The investigators set the threshold for a positive attitude at 24 and consequently the score \<24 point a negative attitude.

Intention will be measured using 1 item with 5 responses: Definitely will, Likely to, Unsure, Not likely to, Definitely will not. The investigators classified "definitely will" and "likely to" as positive intentions.

Participation rate to the breast cancer screening programme will be assessed as a percentage of participants who actually participate, both in intervention and in the control group.

Satisfaction with the given information will be measured using 8 items with three points scale.

Number of click on the Homepage will be assessed trough Pickwick software.

Number of Times Web Platforms were Accessed assessed trough Pickwick software

Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software.

Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.

Mario Negri Institute for Pharmacological Research

The aim of this study is the efficacy of a decision-aid on mammography screening. This is not a pharmacological trial, enrolled patients have access to two different kind of web information. Therefore the safety was not considered in this trial and none of the participating women can be considered at risk of adverse effects. .

Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.

Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Standard Information

Total

Age, Continuous

Sex: Female, Male

Italian

Other

Missing

Race/Ethnicity, Customized

Unmarried

Married or cohabitant

Separated or divorced

Widowed

Marital status

Elementary

Lower middle

Higher middle

Degree

Education

Paid work

No paid work

Employment status

The response rate was lower than expected, and there were about 50% dropouts. We invited more women than expected (21,014 versus 8,160). This high proportion of dropouts could be also due to scarce attention of women to comply with this type of study

Dr. Paola Mosconi and Dr. Anna Roberto

Number of Participants With Adequate Knowledge

Attitude

Intention

Participants who had already had a mammogram in the past 6 months were excluded from this dataset.

Participation Rate to the Breast Cancer Screening Programme

Too much

Too little

Fair

Satisfaction with the information given (intervention and control group) will be measured using 8 items regarding length, quantity, clarity, balance, helpfulness in making decision and women willingness to recommend it to other women with three points scale

Satisfaction With the Information Measured Using 8 Items With Three Points Scale

Number of Click on the Homepage

Number of Times Web Platforms Were Accessed

This outcome has been measured only for the interventional arm (Web Decision-aid is splitted in 16-20 screens) because the control arm was just a single webpage.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)	NCT02914197	Breast Neoplasm	Full informatio...	47 Years - 69 Years	McMaster University
Decision-aid on Breast Cancer Screening	NCT03097653	Breast Cancer	Decision-aid Standard inform...	45 Years - 69 Years	Mario Negri Institute for Pharmacological Research
Decision-aid on Breast Cancer Screening	NCT03097653	Breast Cancer	Decision-aid Standard inform...	45 Years - 69 Years	Mario Negri Institute for Pharmacological Research
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida

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