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

• Sponsor: University of Oviedo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04396665
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.3
• Patients Per Site Per Month: 19.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Women's Health: Neoplasm of Breast	Behavioral: Precam	N/A

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

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Nov 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Precam Group (Intervention Group) 150 Women without breast cancer, aged from 25 to 50 years old	Behavioral: Precam; 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
No Intervention: Control Group 150 Women without breast cancer, aged from 25 to 50 years old

Outcome Measures

Primary Outcome Measures

1. Feasibility of an Educational Intervention: Adherence to the Intervention [6 months]

   Participants that finish the intervention

2. Feasibility of an Educational Intervention: Drop Out After the Intervention Period [6 months]

   People that did not finish the intervention

3. Number of Diet and Activity Recommendations [6 months]

   Mean number of recommendations done by the participants

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Informed consent signed

• Capability to use internet

Exclusion Criteria:

• Breast cancer diagnosis duting the intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oviedo	Oviedo	Asturias	Spain	33006

Sponsors and Collaborators

• University of Oviedo

Investigators

• Principal Investigator: Ruben Martin Payo, PhD, University of Oviedo

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 9, 2020

More Information

Publications

None provided.

• Responsible Party: Rubén Martín Payo, Principal Investigator, University of Oviedo
• ClinicalTrials.gov Identifier: NCT04396665
• Other Study ID Numbers: 147/19
• First Posted: May 20, 2020
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rubén Martín Payo, Principal Investigator, University of Oviedo: Breast neoplasm; Health Promotion; Dietary; Phycical activity; Breast cancer risk
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Precam Group (Intervention Group)	Control Group
Arm/Group Description	150 Women without breast cancer, aged from 25 to 50 years old Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention	150 Women without breast cancer, aged from 25 to 50 years old
Period Title: Overall Study
STARTED	134	90
COMPLETED	99	83
NOT COMPLETED	35	7

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	Women in the Intervention group	Women in the Control group	Total of all reporting groups
Overall Participants	134	90	224
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (6.685)	38.2 (7.334)	39.5 (7.017)
Sex: Female, Male (Count of Participants)
Female	134 100%	90 100%	224 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	134 100%	90 100%	224 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Spain	134 100%	90 100%	224 100%
Studies (Count of Participants)
Non universitary	51 38.1%	24 26.7%	75 33.5%
University	83 61.9%	66 73.3%	149 66.5%
Civil status (Count of Participants)
Single	39 29.1%	36 40%	75 33.5%
Married or similar	79 59%	46 51.1%	125 55.8%
Divorced or widowed	16 11.9%	8 8.9%	24 10.7%

Outcome Measures

1. Primary Outcome

Title	Feasibility of an Educational Intervention: Adherence to the Intervention
Description	Participants that finish the intervention
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Women in the intervention group	Women in the control group
Measure Participants	134	90
Count of Participants [Participants]	99 73.9%	83 92.2%

2. Primary Outcome

Title	Feasibility of an Educational Intervention: Drop Out After the Intervention Period
Description	People that did not finish the intervention
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Women in the intervention group	Women in the control group
Measure Participants	134	90
Count of Participants [Participants]	35 26.1%	7 7.8%

3. Primary Outcome

Title	Number of Diet and Activity Recommendations
Description	Mean number of recommendations done by the participants
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	150 Women without breast cancer, aged from 25 to 50 years old Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention	150 Women without breast cancer, aged from 25 to 50 years old
Measure Participants	99	83
Mean (Standard Deviation) [Number of recommendations]	9.38 (1.789)	8.28 (2.265)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Women in the intervention group	Women in the control group
Measure Participants	99	83
Risk factors knowledge	2.04 (1.531)	1.31 (1.239)
Symptoms knowledge	3.61 (0.636)	3.38 (0.809)

Adverse Events

Adverse Event Reporting Description	Adverse Events were not monitored/assesed
Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	Women in the Intervention group		Women in the Control group
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.