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

Symptoms and General Pathology

Behaviors and Mental Disorders

Digestive System Diseases

Body Weight

Alcohol Drinking

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Drinking Behavior

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.

A leaflet on healthy lifestyle mailed to the participant.

The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.

Individually tailored lifestyle feedback

The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.

Paula Berstad, PhD

This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.

Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women.

Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.

A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.

Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

A score variable ranging from 0 (least favorable) to 6 (most favorable), calculated as the sum of self-reported favorable lifestyle factors assessed by a questionnaire; non-smoking (1 score point), body mass index less than 25 kg/m2 (1 score point), a minimum of seven physical activity sessions of 30 minutes per a week (1 score point), a maximum of four dinner servings of red and processed meat per a week (1 score point), a minimum of three servings of fruit, berries and vegetables per a day (0.5 score point) and a minimum of one serving of fatty fish per a week (0.5 score points)

Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire

Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire

Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire

Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire

Self-reported body weight (whole kilograms), assessed by a questionnaire

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
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
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
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
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

Spots Global Cancer Trial Database for standard leaflet