Skip to main content
OpenTrials
Completed

NCT Number: NCT04150484

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:

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Mindfulness Motor Activity Neoplasms Neoplasms by Site Nutrition Related Cancer Physical Activity Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Mediterranean diet adherence test

    Time frame: 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)

  2. Levels of glucose

    Time frame: 6 months

    Levels of glucose mg/dl

  3. Levels of triglycerides

    Time frame: 6 months

    Levels of triglycerides mg/dl

  4. Levels of cholesterol

    Time frame: 6 months

    Levels of cholesterol mg/dl

  5. 24 hours recall

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • University Hospital Virgen de las Nieves

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.