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

• Sponsor: Universidad de Granada (Other)
• Overall Status: Completed
• CT.gov ID: NCT04150484
• Collaborator: University Hospital Virgen de las Nieves (Other)
• Enrollment: 67
• Arms: 2
• Actual Duration (Months): 29.7

Study Details

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:

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Nutrition Related Cancer; Physical Activity; Mindfulness	Other: Mediterranean diet, physical exercise and mindfulness workshops	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Supportive Care
• Official Title: Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 23, 2017
• Actual Study Completion Date: May 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Quality of life test (EORTC QOL-C30) [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 Outcome Measures

1. Mediterranean diet adherence test [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 [6 months]

   Levels of glucose mg/dl

3. Levels of triglycerides [6 months]

   Levels of triglycerides mg/dl

4. Levels of cholesterol [6 months]

   Levels of cholesterol mg/dl

5. 24 hours recall [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad de Granada
• University Hospital Virgen de las Nieves

Investigators

• Principal Investigator: Julia Ruiz Vozmediano, Dr, Hospital Virgen de las Nieves

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julia Ruiz Vozmediano, Professor, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT04150484
• Other Study ID Numbers: 040907
• First Posted: Nov 4, 2019
• Last Update Posted: Nov 4, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julia Ruiz Vozmediano, Professor, Universidad de Granada: breast cancer survival; mediterranean diet; physical activity; mindfulness
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 4, 2019