Evaluating and Following Breast Cancer Patients in a Better Way

NCT03831308 | Unknown

• 1 other identifier: CentroHLO_EFBreastCancer
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current observational study aims at analysing current semiology on breast cancer patients aiming at noting indicators and signs with significant relationship with the disease outcomes. To reach the primary objective, of identifying most prominent indicators and signs, a study group of at least 100 female patients with breast cancer diagnosis will be recruited to participate voluntarily. The study group will include at least 20 patients with metastatic cancer and 30 patients with indication to adjuvant chemotherapy. Their physical activity habits and lifestyle will be noted. The observational study will consist in the periodic registration of the overall physical and psychological condition. The variables and tests below will be measured and registered, periodically:

• periodical assessment of the quality of life
• periodical assessment of the fitness status of the subjects
• assessment of changes in bone density/progression of osteoporosis
• assessment of changes in cognitive function
• assessment of sleep disorders The collected results will be statistically analysed, in order to:
• Identify variables that are statistically significantly different from expected values
• quantify statistically significant differences, whenever possible The results will be used to better describe the breast cancer population

Conditions

Breast Cancer Female

Keywords

Breast cancer; Physical exercise and Breast Cancer; Cognitive status and Breast Cancer; Physical activity and quality of life of cancer patients; New tools for evaluating breast Cancer patients

Outcome Measures

Primary Outcomes (2)

• Global medical assessment

  during the first medical appointment general health status and cancer staging will be noted for each participant; participants will be asked about their lifestyle, namely to register those with a sedentary lifestyle vs those enrolled in any regular physical activity

  1st month at enrolment

• Assessment of changes in the cardiac function/fitness status of the subjects

  The modified Bruce Protocol is a cardiac stress test that includes 2 warmup stages, each lasting 3 minutes and aims at evaluate the cardiac function will be collected, assessed and registered according to current clinical practice

  1st month at enrolment, 6 and 12 months after enrolment

Secondary Outcomes (3)

• screening sleep disorders and assessing changes in sleeping patterns

  1st month at enrolment, 6 and 12 months after enrolment

• Assessment of changes in bone's density

  1st month at enrolment, 6 and 12 months after enrolment

• Assessment of changes in the cognitive function

  1st month at enrolment, 6 and 12 months after enrolment

Study Arms (1)

Breast cancer new diagnosis

group will include volunteer women, diagnosed with breast cancer, in any stage, aged 18y or more; at least 100 patients will be recruited in medical oncology appointments; all subjects should be periodically submitted to non-invasive evaluation tests - that is, clinical test/clinical and physical assessment to collect information on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life

Diagnostic Test: clinical and physical assessment

Interventions

clinical and physical assessment DIAGNOSTIC_TEST

information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life

Breast cancer new diagnosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Although it may occur, breast cancer is rare in men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women with breast cancer

You may qualify if:

• women
• age \> 18y
• diagnosed with breast cancer

You may not qualify if:

• men
• informed consent

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental: lead
• University of Lisbon: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vasco Fonseca

  Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, Portugal

  PRINCIPAL INVESTIGATOR

• Pedro Sarmento, PhD

  Faculty of Human Motricity - University of Lisbon

  STUDY CHAIR

Central Study Contacts

Vasco Fonseca, Dr

CONTACT

(+351) 210431000; medicinavf@yahoo.com

Pedro Sarmento, PhD

CONTACT

(+ 351) 965289798; pacssarmento@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: February 5, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: February 5, 2019

Record last verified: 2019-02