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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
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 20, 2019
    Last Updated
    October 31, 2019
    Sponsor
    Universidad de Granada
    Collaborators
    University Hospital Virgen de las Nieves
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    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

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

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