NCT04396665: PRECAM-2

Breast Cancer: Feasibility of an Educational Intervention

Completed NA Results posted Last updated 20 August 2021

What this trial tests

NA trial testing Precam in Women's Health: Neoplasm of Breast in 224 participants. Completed in 9 November 2020.

Timeline

1 December 2019

Primary endpoint
31 January 2020

9 November 2020

Quick facts

Lead sponsor	University of Oviedo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	224
Start date	1 December 2019
Primary completion	31 January 2020
Estimated completion	9 November 2020
Sites	1 location across Spain

Drugs / interventions tested

• Precam

Conditions studied

• Women's Health: Neoplasm of Breast — all drugs for Women's Health: Neoplasm of Breast →

Sponsor

University of Oviedo

Who can join

Adults 25 to 50, female only, with Women's Health: Neoplasm of Breast. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of an Educational Intervention: Adherence to the Intervention Primary · 6 months

Participants that finish the intervention

Group	Value	95% CI
Intervention Group	99
Control Group	83

Feasibility of an Educational Intervention: Drop Out After the Intervention Period Primary · 6 months

People that did not finish the intervention

Group	Value	95% CI
Intervention	35
Control	7

Number of Diet and Activity Recommendations Primary · 6 months

Mean number of recommendations done by the participants

Group	Value	95% CI
Intervention Group	9.38	± 1.789
Control Group	8.28	± 2.265

Breast Cancer Awareness Primary · 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)

Risk factors knowledge

Group	Value	95% CI
Intervention	2.04	± 1.531
Control	1.31	± 1.239

Symptoms knowledge

Group	Value	95% CI
Intervention	3.61	± 0.636
Control	3.38	± 0.809

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use a web-app to improve breast cancer risk factors and symptoms knowledge and adherence to healthy diet and physical activity in women without breast cancer diagnosis (Precam project).
   Martín-Payo R, Martínez-Urquijo A, Zabaleta-Del-Olmo E, Del Mar Fernandez-Alvarez M. · · 2023 · cited 8× · PMID 36348211 · DOI 10.1007/s10552-022-01647-x