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

NCT04150484 | Completed

• 1 other identifier: 040907
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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:

Conditions

Breast Cancer; Nutrition Related Cancer; Physical Activity; Mindfulness

Keywords

breast cancer survival; mediterranean diet; physical activity; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mediterranean diet adherence test

  6 months

• Levels of glucose

  6 months

• Levels of triglycerides

  6 months

• Levels of cholesterol

  6 months

• 24 hours recall

  6 months

Study Arms (2)

interventional group

OTHER

dietary intervention, physical exercise and mindfulness

Other: Mediterranean diet, physical exercise and mindfulness workshops

control group

NO INTERVENTION

Group without any intervention.

Interventions

Mediterranean diet, physical exercise and mindfulness workshops OTHER

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.

interventional group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead
• University Hospital Virgen de las Nieves: collaborator

Related Publications (1)

• 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.

  PMID: 32462950 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Diet, Mediterranean; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julia Ruiz Vozmediano, Dr

  Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients between 18 and 70 years of age with breast cancer II-III operable in follow-up, seen in the Oncology service of the Virgen de las Nieves Hospital in Granada and residents in the city or metropolitan area of Granada, which had completed, in the 12 months prior to its inclusion, treatment with surgery, radiotherapy and / or systemic chemotherapy treatment (including biological treatment). Randomized assignment was made based on age, stage, hormone receptor and her2 status, establishing two groups: a group of dietary intervention, physical exercise and mindfulness and another control group. A longitudinal follow-up was carried out for 6 months from the beginning of the intervention.

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: November 4, 2019
• Study Start: December 1, 2016
• Primary Completion: December 23, 2017
• Study Completion: May 25, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Depends of the journal
• Access Criteria: Depends of the journal