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

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Physical Activity; Mindfulness; Nutrition Related Cancer
• Intervention / Treatment: Other: Mediterranean diet, physical exercise and mindfulness workshops

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: interventional group; dietary intervention, physical exercise and mindfulness	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.
No Intervention: control group; Group without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Levels of glucose	Levels of glucose mg/dl	6 months
Levels of triglycerides	Levels of triglycerides mg/dl	6 months
Levels of cholesterol	Levels of cholesterol mg/dl	6 months
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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: University Hospital Virgen de las Nieves
• Investigators: Principal Investigator: Julia Ruiz Vozmediano, Dr, Hospital Virgen de las Nieves

Publications and helpful links

General Publications

• Ruiz-Vozmediano J, Lohnchen S, Jurado L, Recio R, Rodriguez-Carrillo A, Lopez M, Mustieles V, Exposito M, Arroyo-Morales M, Fernandez MF. Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420924757. doi: 10.1177/1534735420924757.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 23, 2017
• Study Completion (Actual): May 25, 2019

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; mindfulness; mediterranean diet; breast cancer survival
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 040907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that and underlie result in a publication
• IPD Sharing Time Frame: Depends of the journal
• IPD Sharing Access Criteria: Depends of the journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No