Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
- Conditions
- Physical ActivityNutrition Related CancerMindfulnessBreast Cancer
- Interventions
- Other: Mediterranean diet, physical exercise and mindfulness workshops
- Registration Number
- NCT04150484
- Lead Sponsor
- Universidad de Granada
- 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:
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 67
- 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).
- Those who presented some physical or psychic limitation that prevented the intervention from being carried out were excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description interventional group Mediterranean diet, physical exercise and mindfulness workshops dietary intervention, physical exercise and mindfulness
- Primary Outcome Measures
Name Time Method Quality of life test (EORTC QOL-C30) 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 Outcome Measures
Name Time Method Levels of glucose 6 months Levels of glucose mg/dl
24 hours recall 6 months Retrospective and quantitative recording method of food and beverage consumption. It consists of remembering all the foods and drinks that were taken the day before.
Mediterranean diet adherence test 6 months Adherence to the traditional Mediterranean diet was assessed by a 14-point Mediterranean-diet scale that incorporated the salient characteristics of this diet (range of scores, 0 to 1, with higher scores indicating greater adherence)
Levels of cholesterol 6 months Levels of cholesterol mg/dl
Levels of triglycerides 6 months Levels of triglycerides mg/dl