Trial Outcomes & Findings for Project Breast47: Effect of an Educational Intervention (NCT NCT05267171)

Last Updated: 2024-10-29

Results Overview

The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).

Recruitment status

COMPLETED

Study phase

Target enrollment

451 participants

Primary outcome timeframe

Baseline

Results posted on

2024-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group Web access: The intervention group will have access to the website where the information is provided. The control group will not have this access.	Control Group The control group will not have this access.
Overall Study STARTED	207	244
Overall Study COMPLETED	101	188
Overall Study NOT COMPLETED	106	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.	Total n=451 Participants Total of all reporting groups
Age, Continuous	38.88 years STANDARD_DEVIATION 5.56 • n=207 Participants	38.76 years STANDARD_DEVIATION 5.28 • n=244 Participants	38.82 years STANDARD_DEVIATION 5.36 • n=451 Participants
Sex/Gender, Customized Women	207 Participants n=207 Participants	244 Participants n=244 Participants	451 Participants n=451 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Civil Status Single	50 Participants n=207 Participants	60 Participants n=244 Participants	110 Participants n=451 Participants
Civil Status Separated, divorced or widowed	10 Participants n=207 Participants	4 Participants n=244 Participants	14 Participants n=451 Participants
Civil Status Married or in a relationship	147 Participants n=207 Participants	180 Participants n=244 Participants	327 Participants n=451 Participants
Educational level Primary studies	6 Participants n=207 Participants	2 Participants n=244 Participants	8 Participants n=451 Participants
Educational level Secondary studies	17 Participants n=207 Participants	16 Participants n=244 Participants	33 Participants n=451 Participants
Educational level High school studies	21 Participants n=207 Participants	24 Participants n=244 Participants	45 Participants n=451 Participants
Educational level University studies	101 Participants n=207 Participants	129 Participants n=244 Participants	230 Participants n=451 Participants
Educational level Others	62 Participants n=207 Participants	73 Participants n=244 Participants	135 Participants n=451 Participants
Employment Employed	171 Participants n=207 Participants	213 Participants n=244 Participants	384 Participants n=451 Participants
Employment Unemployed	36 Participants n=207 Participants	31 Participants n=244 Participants	67 Participants n=451 Participants
Family history of cancer Yes	152 Participants n=207 Participants	177 Participants n=244 Participants	329 Participants n=451 Participants
Family history of cancer No	55 Participants n=207 Participants	67 Participants n=244 Participants	122 Participants n=451 Participants
History of breast cancer in the family Yes	67 Participants n=207 Participants	86 Participants n=244 Participants	153 Participants n=451 Participants
History of breast cancer in the family No	140 Participants n=207 Participants	158 Participants n=244 Participants	298 Participants n=451 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.
Behavioral BC Risk With an Educational Intervention for Prevention	8.10 units on a scale Standard Deviation 2.57	8.15 units on a scale Standard Deviation 2.60

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

PostIntervention - Feasibility will be measured with satisfaction questionnaire. Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system. It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree. After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered "good usability." Equal to or greater than 85 is considered "excellent usability". This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app.

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group The control group will not have this access.
Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App	71.87 units on a scale Standard Deviation 17.94	—

PRIMARY outcome

Timeframe: Baseline

Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms. The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.

Outcome measures

Outcome measures
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.
Knowledge of BC Risk With an Educational Intervention for Prevention	4.61 units on a scale Standard Deviation 2.01	4.65 units on a scale Standard Deviation 2.04

PRIMARY outcome

Timeframe: Baseline

Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).

Outcome measures

Outcome measures
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.
Barriers to Prevent BC With an Educational Intervention for Prevention	28.60 units on a scale Standard Deviation 3.70	28.77 units on a scale Standard Deviation 4.03

PRIMARY outcome

Timeframe: Baseline

Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).

Outcome measures

Outcome measures
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.
BC Risk Perception With an Educational Intervention for Prevention	11.34 units on a scale Standard Deviation 2.89	11.22 units on a scale Standard Deviation 3.04

PRIMARY outcome

Timeframe: Baseline

Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.

Outcome measures

Outcome measures
Measure	Intervention Group n=207 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=244 Participants The control group will not have this access.
Breast Self-examination With an Educational Intervention for Prevention Breast self-examination	123 Participants	142 Participants
Breast Self-examination With an Educational Intervention for Prevention No breast self-examination	84 Participants	102 Participants

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

Post Intervention - Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=188 Participants The control group will not have this access.
Knowledge of BC Risk With an Educational Intervention for Prevention	10.19 units on a scale Standard Deviation 3.07	11.11 units on a scale Standard Deviation 3.14

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

PostIntervention - The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=188 Participants The control group will not have this access.
Behavioral BC Risk With an Educational Intervention for Prevention	9.21 units on a scale Standard Deviation 2.20	8.40 units on a scale Standard Deviation 2.59

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=188 Participants The control group will not have this access.
Knowledge for BC Risk With an Educational Intervention for Prevention	5.87 units on a scale Standard Deviation 1.71	5.13 units on a scale Standard Deviation 1.97

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

PostIntervention - Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=188 Participants The control group will not have this access.
Barriers to Prevent BC With an Educational Intervention for Prevention	29.59 units on a scale Standard Deviation 3.68	28.88 units on a scale Standard Deviation 4.24

PRIMARY outcome

Timeframe: 12 weeks (end of intervention)

PostIntervention - Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.

Outcome measures

Outcome measures
Measure	Intervention Group n=101 Participants Web access: The intervention group will have access to the website where the information is provided.	Control Group n=188 Participants The control group will not have this access.
Breast Self-examination With an Educational Intervention for Prevention Breast self-examination	83 Participants	122 Participants
Breast Self-examination With an Educational Intervention for Prevention No breast self-examination	18 Participants	66 Participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claudia Leirós Díaz

Universidad de Oviedo

Phone: 663571819

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place