Stress Management and Biological Age in Breast Cancer Patients.RCT

Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.

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 and blood material extraction.

Understanding the role of stress management in breast cancer may lead to improved patient outcomes and survival rates.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Stress; Telomere Length, Mean Leukocyte
• Intervention / Treatment: Behavioral: One day seminar; Behavioral: PSAI

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 and extracting genetic (DNA) material to study the telomere length of T-cells from peripheral blood and Total Oxidative Stress status.

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11522
    • Agios Savvas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; One day seminar where they receive information about stress and lifestyle modifications	Behavioral: One day seminar; 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.
Experimental: PSAI group; Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 6 weeks and they receive information about stress and lifestyle modifications and they are also instructed to practice the PSAI at bedtime and in the morning, every day, at home.	Behavioral: PSAI; The 6 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.; Other Names: Pythagorean Self-Awareness Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical I	Telomere length (measured in mean T/S)	9 weeks after the 1st session
Physical II	Total Oxidant Status. Measured in blood serum. Expected outcome: decrease.	9 weeks after the 1st session
Physical III	Body Composition Analysis (assessed by bio-impedance device)	9 weeks after the 1st session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological I	Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)	9 weeks after the 1st session
Psychological II	Symptoms of anxiety-depression (measured by Hospital Anxiety Depression Scale, expected decrease in mean scores)	9 weeks after the 1st session
Psychological III	Concerns about cancer recurrence (measured by Concerns About Recurrence Scale, expected decrease in means score)	9 weeks after the 1st session
Lifestyle parameter I	Adherence to Mediterrenean Diet (measured by MedDiet, expected increase in means score)	9 weeks after the 1st session
Lifestyle parameter II	Adherence to a Healthy Lifestyle (measured by Healthy Lifestyle and Personal Control Questionnaire, expected increase in means score)	9 weeks after the 1st session
Lifestyle parameter III	Sleep quality (measured by Pittsburgh Sleep Quality Index, expected decrease in means score)	9 weeks after the 1st session
Lifestyle parameter IV	Physical activity (measured by International Physical Activity Questionnaire -7, expected increase in METs/week)	9 weeks after the 1st session

Collaborators and Investigators

• Sponsor: Maria Charalampopoulou
• Collaborators: Hippocration General Hospital; Saint Savvas Anticancer Hospital; Hellenic Anticancer Institute
• Investigators: Study Director: Flora Bacopoulou, MD,PhD, Aghia Sofia Hospital

Publications and helpful links

General Publications

• Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.
• Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2.
• Lin Y, Wang C, Zhong Y, Huang X, Peng L, Shan G, Wang K, Sun Q. Striking life events associated with primary breast cancer susceptibility in women: a meta-analysis study. J Exp Clin Cancer Res. 2013 Aug 13;32(1):53. doi: 10.1186/1756-9966-32-53.
• Damjanovic AK, Yang Y, Glaser R, Kiecolt-Glaser JK, Nguyen H, Laskowski B, Zou Y, Beversdorf DQ, Weng NP. Accelerated telomere erosion is associated with a declining immune function of caregivers of Alzheimer's disease patients. J Immunol. 2007 Sep 15;179(6):4249-54. doi: 10.4049/jimmunol.179.6.4249.
• Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, Degelman ES, Speca M. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015 Feb 1;121(3):476-84. doi: 10.1002/cncr.29063. Epub 2014 Nov 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2022
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Stress; Biological age; Lifestyle; Telomeres; PSAI; Stress management
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: After publication of the study
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No