Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women

NCT03918668 | Completed

• 1 other identifier: PI-2842
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most frequent tumor in Western women. In Spain about 26,000 new breast cancers are diagnosed each year. This type of tumor is increasing worldwide with an increase in aggressive neoplasms in young women. There are some risk factors responsible for this global increase: lifestyle, diet and body weight especially in postmenopausal women. Some cell mutations, especially in the BRCA1, BRCA2 and p53 genes, are associated with a very high risk of this type of cancer. Some authors have calculated the contribution of various modifiable risk factors to the global burden of breast cancer, and they concluded that 21% of all breast cancer deaths are attributable to alcohol consumption, overweight and obesity, and lack of physical activity. Nowadays, there aren't specific studies in the Community of Madrid designed to know the risk factors related to breast cancer. For this reason, it is proposed to carry out an observational study that collects detailed information about dietary habits, genetic factors and life quality of a group of women with recent diagnosis in pre or post-surgical phase.

Conditions

Breast Neoplasm Female; Nutrition Related Cancer; Habits, Diet; Cancer, Breast

Keywords

breast neoplasm; cancer; risk factor; nutrition

Outcome Measures

Primary Outcomes (1)

• Dietary habits of a group of women with pre and post-surgical breast cancer

  Frequency of Consumption of food questionnaire referring. The frequency varies between one time per day and one time per month for every type of food during the last 6 months. to the last year of the volunteer's eating habits before being breast cancer diagnosed

  Six months

Interventions

Women with recent diagnosis of breast cancer BEHAVIORAL

To evaluate dietary habits of a group of women with pre and post-surgical breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with a recent diagnosis of breast cancer

You may qualify if:

• Older women than 18 years old
• Newly diagnosed patients with a breast tumor (Phase I, II or III). Being in one of the following cases:
• Patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy.
• Patient who has just undergone surgery and is waiting to start adjuvant treatment with chemo or radiotherapy.
• Sign the informed consent.

You may not qualify if:

• Patients with stage IV disease.
• Associated Eating Disorders.
• Patients with dementia, mental illness or decreased cognitive function.
• Pregnant or lactating women.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Feeding Behavior; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carmen Gómez Candela, Msc

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: April 17, 2019
• Study Start: July 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: July 20, 2021

Record last verified: 2019-02

Locations

ES (1)