NCT04424758

Brief Summary

This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

May 28, 2020

Last Update Submit

July 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Choice: proportion of participants in favor of mammography screening

    The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.

    One month

Secondary Outcomes (2)

  • Response duration: time

    One month

  • Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.

    One month

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.

Other: Video information about mammography screening

Control group

PLACEBO COMPARATOR

Receives information about energy systems through a video. The video does not contain any information related to mammography screening.

Other: Video information about smart energy systems

Interventions

A video informing about mammography screening

Intervention group

A video informing about smart energy systems

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants eligible for the study includes all men and women age 18-75.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Section of General Practice

Copenhagen, Capital, 1014, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Manja Jensen, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manja Jensen, MD

CONTACT

John Brodersen, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
See protocol
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: See protocol
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Medical doctor, PhD-student

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 11, 2020

Study Start

June 16, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

When the study is completed, access to study data will be provided by the PI on request.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be stored until 2050.
Access Criteria
Data will be provided by the PI on request.

Locations