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Clinical Trials/NCT04150484
NCT04150484
Completed
Not Applicable

Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer

Universidad de Granada0 sites67 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Universidad de Granada
Enrollment
67
Primary Endpoint
Quality of life test (EORTC QOL-C30)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

ABSTRACT

BACKGROUND:

Breast Cancer (BC) is one of the leading causes of death among women around the world. Integrative oncology, together with conventional medical treatment, has proven to be an important support for the control of cancer symptoms, improvement of quality of life, and contribution to the overall patient health, providing an integrated patient care both physically and emotionally.

METHODS:

75 stage II-III breast cancer survivors were randomized (according to age, tumor stage and receptor status) into 2 groups: intervention and control. Within the intervention group (IG) a diet, exercise and mindfulness intervention was performed, while the control group (CG) did not receive any sort of treatment, during 6 months. Passed (at the beginning and end of the research) questionnaires concerning general health, quality of life (EORTC QLQ-C30 and BR23), and diet (Mediterranean diet adherence test and 24-h-recall) and a blood and urine sample was collected to analyze general biochemical variables.

RESULTS:

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
May 25, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julia Ruiz Vozmediano

Professor

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Patients between 18 and 70 years of age
  • Breast cancer IIA-IIB operable in follow-up
  • Seen in the Oncology service of the Virgen de las Nieves Hospital in Granada
  • Residents in the city or metropolitan area of Granada
  • Had completed, in the 12 months prior to its inclusion, treatment with surgery, radiotherapy and / or systemic chemotherapy treatment (including biological treatment).

Exclusion Criteria

  • Those who presented some physical or psychic limitation that prevented the intervention from being carried out were excluded from the study.

Outcomes

Primary Outcomes

Quality of life test (EORTC QOL-C30)

Time Frame: 6 months

It includes 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers they obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")

Secondary Outcomes

  • 24 hours recall(6 months)
  • Mediterranean diet adherence test(6 months)
  • Levels of cholesterol(6 months)
  • Levels of triglycerides(6 months)
  • Levels of glucose(6 months)

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