Clinical trial NCT04150484: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Nutrition Related Cancer
Physical Activity
Mindfulness
Keywords: breast cancer survival
mediterranean diet
physical activity
mindfulness
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
First posted: 2019-11-04
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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:


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.

Primary outcomes:
measure: Quality of life test (EORTC QOL-C30)
timeFrame: 6 months
Secondary outcomes:
measure: Mediterranean diet adherence test
timeFrame: 6 months
measure: Levels of glucose
timeFrame: 6 months
measure: Levels of triglycerides
timeFrame: 6 months
measure: Levels of cholesterol
timeFrame: 6 months
measure: 24 hours recall
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Virgen de las Nieves
name: Julia Ruiz Vozmediano, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.