search
Back to results

Breast Cancer: Feasibility of an Educational Intervention (PRECAM-2)

Primary Purpose

Women's Health: Neoplasm of Breast

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Precam
Sponsored by
University of Oviedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Women's Health: Neoplasm of Breast focused on measuring Breast neoplasm, Health Promotion, Dietary, Phycical activity, Breast cancer risk

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent signed
  • Capability to use internet

Exclusion Criteria:

  • Breast cancer diagnosis duting the intervention

Sites / Locations

  • University of Oviedo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Precam Group (Intervention Group)

Control Group

Arm Description

150 Women without breast cancer, aged from 25 to 50 years old

150 Women without breast cancer, aged from 25 to 50 years old

Outcomes

Primary Outcome Measures

Feasibility of an Educational Intervention: Adherence to the Intervention
Participants that finish the intervention
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
People that did not finish the intervention
Number of Diet and Activity Recommendations
Mean number of recommendations done by the participants
Breast Cancer Awareness
Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score)

Secondary Outcome Measures

Full Information

First Posted
March 29, 2020
Last Updated
August 19, 2021
Sponsor
University of Oviedo
search

1. Study Identification

Unique Protocol Identification Number
NCT04396665
Brief Title
Breast Cancer: Feasibility of an Educational Intervention
Acronym
PRECAM-2
Official Title
Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias. Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. Informed consent signed. Variables: personal characteristics (age, status, educational level, occupation), MIC index, dietary characteristics, level of physical activity, presence of known risks of breast cancer (number of children, breastfeeding, oral contraceptives, family history of cancer, previous cancer, breast density and knowledge related with breast cancer prevention. Intervention: Intervention Group:6 months intervention using a web-app related with personal care and breast cancer risks, diet and physical activity. Control Group: no intervention.
Detailed Description
Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias. Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. They are recluted for a previous study developed by the same research team. An information document and a written consent was given for the women. Those who signed the consent are included. The randomization for intervention or control group are doing based on the where the city where the women home is located. the objective of this distribution is to avoid contact between women from different groups. Variables: personal characteristics (age, status, educational level, civil status), MIC index, dietary characteristics, level of physical activity, knowledge related with breast cancer symptoms and risk factors. Intervention: The 6 months intervention are going to be developed using a web-app. The intervention is based on the Behavior Change Wheel model. Capacity and motivation are going to be the determinants on which it will work using for it interventions based on education, persuasion and modeling among others. Intervention Group: 6 months intervention using a web-app related. The web-app includes some sections: Information related with breast cancer risk. Breast self examination. Written text and videos done by a nurse. Physical exercise. Written text and videos done by a physiotherapist . Dietary information. Written text and videos done by a nutrition expert. The Control Group are not going to receive intervention during the study period time. After that, women are going to be access to the web-app. Statistical analysis Descriptive statistics will be carried out (means, standard deviation, CI and percentages). In addition, at the end of the study, in order to determine the factibility of the educational intervention, the variation of the intra-group data (from pre to psot-test) and between the groups in post-test will be compared using the chi-square test. , t-student or Mann-Whitney U, for qualitative or quantitative data respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health: Neoplasm of Breast
Keywords
Breast neoplasm, Health Promotion, Dietary, Phycical activity, Breast cancer risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precam Group (Intervention Group)
Arm Type
Experimental
Arm Description
150 Women without breast cancer, aged from 25 to 50 years old
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
150 Women without breast cancer, aged from 25 to 50 years old
Intervention Type
Behavioral
Intervention Name(s)
Precam
Intervention Description
6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
Primary Outcome Measure Information:
Title
Feasibility of an Educational Intervention: Adherence to the Intervention
Description
Participants that finish the intervention
Time Frame
6 months
Title
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
Description
People that did not finish the intervention
Time Frame
6 months
Title
Number of Diet and Activity Recommendations
Description
Mean number of recommendations done by the participants
Time Frame
6 months
Title
Breast Cancer Awareness
Description
Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Informed consent signed Capability to use internet Exclusion Criteria: Breast cancer diagnosis duting the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Martin Payo, PhD
Organizational Affiliation
University of Oviedo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oviedo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymizes data are going to be published but we are not going to analizase individual data.

Learn more about this trial

Breast Cancer: Feasibility of an Educational Intervention

We'll reach out to this number within 24 hrs