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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150484
• Other study ID #: 040907
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: May 25, 2019

Study information

• Verified date: October 2019
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 25, 2019
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Mindfulness
• Nutrition Related Cancer
• Physical Activity

Intervention

Other:
• Mediterranean diet, physical exercise and mindfulness workshops
a group of dietary intervention, physical exercise and mindfulness and another control group, and a longitudinal follow-up was carried out for 6 months from the beginning of the intervention.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	University Hospital Virgen de las Nieves

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life test (EORTC QOL-C30)	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")	6 months
Secondary	Mediterranean diet adherence test	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)	6 months
Secondary	Levels of glucose	Levels of glucose mg/dl	6 months
Secondary	Levels of triglycerides	Levels of triglycerides mg/dl	6 months
Secondary	Levels of cholesterol	Levels of cholesterol mg/dl	6 months
Secondary	24 hours recall	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.	6 months