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Trial Title:
Stress Management and Biological Age in Breast Cancer Patients.RCT
NCT ID:
NCT05984914
Condition:
Stress
Breast Cancer
Telomere Length, Mean Leukocyte
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Stress
Breast Cancer
Lifestyle
Stress management
Telomeres
Biological age
PSAI
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PSAI
Description:
The 8 sessions included biofeedback training in diaphragmatic breathing, information
about distress, its symptoms, ways to manage stress through lifestyle modifications
(physical activity, principals of Mediterranean diet without alcohol consumption, sleep
hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema
prevention, introduction to the Pythagorean Self-Awareness Intervention, instructions for
the implementation of the technique, analysis of the Golden Verses,and their connection
with lifestyle medicine as well as active involvement of the participants with group
conversation and sharing of experiences.
Arm group label:
PSAI group
Other name:
Pythagorean Self-Awareness Intervention
Intervention type:
Behavioral
Intervention name:
One day seminar
Description:
The one day seminar included biofeedback training in diaphragmatic breathing, information
about distress, its symptoms, ways to manage stress through lifestyle modifications
(physical activity, principals of Mediterranean diet without alcohol consumption, sleep
hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema
prevention.
Arm group label:
Control group
Summary:
Intense stress has harmful effects on the body, contributing to various disorders. Breast
cancer patients experience a build-up of stress due to their diagnosis and treatments.
Stress can cause epigenetic changes in a cellular level (such as accelerated increase in
biological age) that may negatively affect oncological treatments.
This study aims to investigate the effect of stress management, specifically the
Pythagorean Self-Awareness Intervention, on telomere length in T-leukocytes of breast
cancer patients after completing all treatments except hormonal therapy. The study
involves self-referred questionnaires, hair cortisol collection, and blood material
extraction.
Understanding the role of stress management in breast cancer may lead to improved patient
outcomes and survival rates.
Detailed description:
Distress can have serious effects on the human body and is known to contribute to various
disorders, including cardiovascular diseases. In the case of breast cancer, patients
often experience a build-up of stressful events throughout their journey with the
disease, such as diagnosis, surgery, chemotherapy, radiotherapy, survival, and dealing
with side effects of anticancer therapy.
Many studies have shown that psychological stress is closely related to increased
cortisol levels in the body. This stress may lead to epigenetic changes in telomere
length, the action of telomerase, the function of T-leukocytes, and the response of
pro-inflammatory cytokines, all of which play significant roles in the treatment of
oncological patients.
Considering these factors, managing stress becomes crucial, as it can not only indirectly
affect the disease's outcome but also impact survival. This scientific protocol aims to
investigate the impact of a holistic stress management program on the telomere length of
T-leukocytes in the peripheral blood of women diagnosed with breast cancer.
The stress management technique to be employed is the Pythagorean Self-Awareness
Intervention, which will be administered only after completing all cancer treatments,
except for hormonal therapy. The methods that will be followed include distributing
self-referred questionnaires to assess stress and lifestyle, collecting hair cortisol
samples, and extracting genetic (DNA) material to study the telomere length of T-cells
from peripheral blood.
By studying the impact of stress and its management on telomere length in breast cancer
patients, this study aims to contribute to a better understanding of how stress affects
health outcomes and potentially provide insights into improving patient care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of primary breast cancer
- Completion of anticancer therapy (except for hormonal therapy)
Exclusion Criteria:
- Psychiatric diagnosis and treatment
- Metastasis
- Previous participation in any stress management and health promotion study
- Inability to read or write in Greek
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Agios Savvas Hospital
Address:
City:
Athens
Zip:
11522
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Dimitrios Tryfonopoulos, MD,PhD
Phone:
+306932669110
Email:
oncology2@agsavvas-hosp.grm
Investigator:
Last name:
Maria Charalampopoulou, PT, CDT, MSc
Email:
Principal Investigator
Start date:
January 4, 2021
Completion date:
January 2024
Lead sponsor:
Agency:
Maria Charalampopoulou
Agency class:
Other
Collaborator:
Agency:
Hippocration General Hospital
Agency class:
Other
Collaborator:
Agency:
Saint Savvas Anticancer Hospital
Agency class:
Other
Collaborator:
Agency:
Hellenic Anticancer Institute
Agency class:
Other
Source:
National and Kapodistrian University of Athens
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984914
