Women's Health: Neoplasm of Breast
Conditions
Keywords
Breast neoplasm, Health Promotion, Dietary, Phycical activity, Breast cancer risk
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.
Interventions
BEHAVIORALPrecam
6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
Sponsors
University of Oviedo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent signed * Capability to use internet
Exclusion criteria
* Breast cancer diagnosis duting the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of an Educational Intervention: Adherence to the Intervention | 6 months | Participants that finish the intervention |
| Feasibility of an Educational Intervention: Drop Out After the Intervention Period | 6 months | People that did not finish the intervention |
| Number of Diet and Activity Recommendations | 6 months | Mean number of recommendations done by the participants |
| Breast Cancer Awareness | 6 months | 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) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Women in the Intervention group | 134 |
| Control Group Women in the Control group | 90 |
| Total | 224 |
Baseline characteristics
| Characteristic | Total | Intervention Group | Control Group |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 7.017 | 40.4 years STANDARD_DEVIATION 6.685 | 38.2 years STANDARD_DEVIATION 7.334 |
| Civil status Divorced or widowed | 24 Participants | 16 Participants | 8 Participants |
| Civil status Married or similar | 125 Participants | 79 Participants | 46 Participants |
| Civil status Single | 75 Participants | 39 Participants | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 224 Participants | 134 Participants | 90 Participants |
| Region of Enrollment Spain | 224 participants | 134 participants | 90 participants |
| Sex: Female, Male Female | 224 Participants | 134 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Studies Non universitary | 75 Participants | 51 Participants | 24 Participants |
| Studies University | 149 Participants | 83 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Breast Cancer Awareness | Risk factors knowledge | 2.04 units on a scale | Standard Deviation 1.531 |
| Intervention Group | Breast Cancer Awareness | Symptoms knowledge | 3.61 units on a scale | Standard Deviation 0.636 |
| Control Group | Breast Cancer Awareness | Risk factors knowledge | 1.31 units on a scale | Standard Deviation 1.239 |
| Control Group | Breast Cancer Awareness | Symptoms knowledge | 3.38 units on a scale | Standard Deviation 0.809 |
Primary
Feasibility of an Educational Intervention: Adherence to the Intervention
Participants that finish the intervention
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Feasibility of an Educational Intervention: Adherence to the Intervention | 99 Participants |
| Control Group | Feasibility of an Educational Intervention: Adherence to the Intervention | 83 Participants |
Primary
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
People that did not finish the intervention
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Feasibility of an Educational Intervention: Drop Out After the Intervention Period | 35 Participants |
| Control Group | Feasibility of an Educational Intervention: Drop Out After the Intervention Period | 7 Participants |
Primary
Number of Diet and Activity Recommendations
Mean number of recommendations done by the participants
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Number of Diet and Activity Recommendations | 9.38 Number of recommendations | Standard Deviation 1.789 |
| Control Group | Number of Diet and Activity Recommendations | 8.28 Number of recommendations | Standard Deviation 2.265 |