Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
Primary Purpose
Breast Cancer, Nutrition Related Cancer, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediterranean diet, physical exercise and mindfulness workshops
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer survival, mediterranean diet, physical activity, mindfulness
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
interventional group
control group
Arm Description
dietary intervention, physical exercise and mindfulness
Group without any intervention.
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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)
Levels of glucose
Levels of glucose mg/dl
Levels of triglycerides
Levels of triglycerides mg/dl
Levels of cholesterol
Levels of cholesterol mg/dl
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.
Full Information
NCT ID
NCT04150484
First Posted
October 20, 2019
Last Updated
October 31, 2019
Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves
1. Study Identification
Unique Protocol Identification Number
NCT04150484
Brief Title
Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
Official Title
Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 23, 2017 (Actual)
Study Completion Date
May 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Nutrition Related Cancer, Physical Activity, Mindfulness
Keywords
breast cancer survival, mediterranean diet, physical activity, mindfulness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interventional group
Arm Type
Other
Arm Description
dietary intervention, physical exercise and mindfulness
Arm Title
control group
Arm Type
No Intervention
Arm Description
Group without any intervention.
Intervention Type
Other
Intervention Name(s)
Mediterranean diet, physical exercise and mindfulness workshops
Intervention Description
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 Outcome Measure Information:
Title
Quality of life test (EORTC QOL-C30)
Description
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")
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mediterranean diet adherence test
Description
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)
Time Frame
6 months
Title
Levels of glucose
Description
Levels of glucose mg/dl
Time Frame
6 months
Title
Levels of triglycerides
Description
Levels of triglycerides mg/dl
Time Frame
6 months
Title
Levels of cholesterol
Description
Levels of cholesterol mg/dl
Time Frame
6 months
Title
24 hours recall
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Ruiz Vozmediano, Dr
Organizational Affiliation
Hospital Virgen de las Nieves
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32462950
Citation
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.
Results Reference
derived
Learn more about this trial
Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
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