Women's Health: Neoplasm of BreastPRECAM-2NCT04396665
Breast Cancer: Feasibility of an Educational Intervention
A study testing Precam in people with Women's Health: Neoplasm of Breast, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health: Neoplasm of Breast
- What is being tested?
- Precam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 9 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent signed
- Capability to use internet
Who cannot join
- Breast cancer diagnosis duting the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application
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.
Read more
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.
Read the 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.
- Conditions
- Women's Health: Neoplasm of Breast
- Being tested
- Precam
- Keywords
- Breast neoplasm, Health Promotion, Dietary, Phycical activity, Breast cancer risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecamBehavioural
6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
| Study group | Role | What they receive |
|---|---|---|
| Precam Group (Intervention Group) | Experimental | 150 Women without breast cancer, aged from 25 to 50 years old Receives: Behavioral: Precam |
| Control Group | No intervention | 150 Women without breast cancer, aged from 25 to 50 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of an Educational Intervention: Adherence to the Intervention
Participants that finish the intervention
Measured: 6 months
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
People that did not finish the intervention
Measured: 6 months
Number of Diet and Activity Recommendations
Mean number of recommendations done by the participants
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Dec 2019
- Primary completion31 Jan 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Women's Health: Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Martín Payo, University of Oviedo
- Investigators
- Ruben Martin Payo, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396665
- Sponsor's protocol ID
- 147/19
- Acronym
- PRECAM-2
- Status last verified
- Aug 2021
- First submitted
- 29 Mar 2020
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymizes data are going to be published but we are not going to analizase individual data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application
- ClinicalTrials.gov ID
- NCT04396665
- Acronym / sponsor ID
- PRECAM-2 / 147/19
- Conditions
- Women's Health: Neoplasm of Breast
- Keywords
- Breast neoplasm, Health Promotion, Dietary, Phycical activity, Breast cancer risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precam Group (Intervention Group) | Experimental | Behavioral: Precam150 Women without breast cancer, aged from 25 to 50 years old |
| Control Group | No intervention | –150 Women without breast cancer, aged from 25 to 50 years old |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Informed consent signed
- Capability to use internet
Key exclusion criteria (1 listed)
- Breast cancer diagnosis duting the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precam6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention | Behavioural | Precam Group (Intervention Group) |
Primary outcome
Feasibility of an Educational Intervention: Adherence to the Intervention
Time frame: 6 months
Participants that finish the intervention
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
Time frame: 6 months
People that did not finish the intervention
Number of Diet and Activity Recommendations
Time frame: 6 months
Mean number of recommendations done by the participants
Breast Cancer Awareness
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Anonymizes data are going to be published but we are not going to analizase individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Martin Payo, PhD principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precam in people with Women's Health: Neoplasm of Breast, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of an Educational Intervention: Adherence to the Intervention (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.