Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03046004
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Hospital del Mar
Canary Islands Health Service
Catalan Institute of Oncology
Information provided by (Responsible Party):
Montserrat Rue, Institut de Recerca Biomèdica de Lleida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Screening Other: Decision aid for breast cancer screening Other: Standard leaflet Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : September 14, 2017
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Decision aid
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).
Other: Decision aid for breast cancer screening
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).

Active Comparator: Control
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.
Other: Standard leaflet
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.




Primary Outcome Measures :
  1. Informed choice [ Time Frame: Two weeks after the intervention ]
    The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.


Secondary Outcome Measures :
  1. Breast screening attitudes [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  2. Breast screening intention [ Time Frame: Two weeks after the intervention and after being invited to be screened ]
    According to Hersch 2015

  3. Decisional conflict [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  4. Confidence in the decision made [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  5. Anxiety about screening participation [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  6. Worry about breast cancer [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  7. Anticipated regret [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  8. Time perspective [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  9. Perceived importance of benefit/harms of screening [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015

  10. Perceived risk of breast cancer [ Time Frame: Two weeks after the intervention ]
    According to Hersch 2015



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   49 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands.
  • Women with low health literacy will be included

Exclusion Criteria:

  • Previous history of breast cancer
  • Difficulty speaking Spanish or Catalan
  • Cognitive impairment to understand or complete the materials based on the interviewer judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046004


Locations
Layout table for location information
Spain
Lleida Biomedical Research Institute (IRBLLEIDA)
Lleida, Spain, 25198
Sponsors and Collaborators
Institut de Recerca Biomèdica de Lleida
Hospital del Mar
Canary Islands Health Service
Catalan Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: Montserrat Rué, PhD Universitat de Lleida-IRBLLEIDA
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Montserrat Rue, Professor, Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT03046004    
Other Study ID Numbers: PI14/00113
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montserrat Rue, Institut de Recerca Biomèdica de Lleida:
breast cancer
screening
decision aid
informed choice
decisional conflict
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases