Trial Outcomes & Findings for Breast Cancer: Feasibility of an Educational Intervention (NCT NCT04396665)
NCT ID: NCT04396665
Last Updated: 2021-08-20
Results Overview
Participants that finish the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-20
Participant Flow
Participant milestones
| Measure |
Precam Group (Intervention Group)
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
|
Control Group
150 Women without breast cancer, aged from 25 to 50 years old
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
90
|
|
Overall Study
COMPLETED
|
99
|
83
|
|
Overall Study
NOT COMPLETED
|
35
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breast Cancer: Feasibility of an Educational Intervention
Baseline characteristics by cohort
| Measure |
Intervention Group
n=134 Participants
Women in the Intervention group
|
Control Group
n=90 Participants
Women in the Control group
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 6.685 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 7.334 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 7.017 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
134 participants
n=5 Participants
|
90 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Studies
Non universitary
|
51 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Studies
University
|
83 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Civil status
Single
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Civil status
Married or similar
|
79 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Civil status
Divorced or widowed
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsParticipants that finish the intervention
Outcome measures
| Measure |
Intervention Group
n=134 Participants
Women in the intervention group
|
Control Group
n=90 Participants
Women in the control group
|
|---|---|---|
|
Feasibility of an Educational Intervention: Adherence to the Intervention
|
99 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPeople that did not finish the intervention
Outcome measures
| Measure |
Intervention Group
n=134 Participants
Women in the intervention group
|
Control Group
n=90 Participants
Women in the control group
|
|---|---|---|
|
Feasibility of an Educational Intervention: Drop Out After the Intervention Period
|
35 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMean number of recommendations done by the participants
Outcome measures
| Measure |
Intervention Group
n=99 Participants
Women in the intervention group
|
Control Group
n=83 Participants
Women in the control group
|
|---|---|---|
|
Number of Diet and Activity Recommendations
|
9.38 Number of recommendations
Standard Deviation 1.789
|
8.28 Number of recommendations
Standard Deviation 2.265
|
PRIMARY outcome
Timeframe: 6 monthsUsing 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)
Outcome measures
| Measure |
Intervention Group
n=99 Participants
Women in the intervention group
|
Control Group
n=83 Participants
Women in the control group
|
|---|---|---|
|
Breast Cancer Awareness
Risk factors knowledge
|
2.04 units on a scale
Standard Deviation 1.531
|
1.31 units on a scale
Standard Deviation 1.239
|
|
Breast Cancer Awareness
Symptoms knowledge
|
3.61 units on a scale
Standard Deviation 0.636
|
3.38 units on a scale
Standard Deviation 0.809
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place