Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 67
- Primary Endpoint
- Quality of life test (EORTC QOL-C30)
Study 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
interventional group
dietary intervention, physical exercise and mindfulness
Intervention: Mediterranean diet, physical exercise and mindfulness workshops (Other)
control group
Group without any intervention.
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)
Investigators
Julia Ruiz Vozmediano
Professor
Universidad de Granada