Stress Management and Biological Age in Breast Cancer Patients.RCT

NCT05984914 | Completed

• 1 other identifier: 2513
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Stress; Breast Cancer; Telomere Length, Mean Leukocyte

Keywords

Stress; Breast Cancer; Lifestyle; Stress management; Telomeres; Biological age; PSAI

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Psychological I

  9 weeks after the 1st session

• Psychological II

  9 weeks after the 1st session

• Psychological III

  9 weeks after the 1st session

• Lifestyle parameter I

  9 weeks after the 1st session

• Lifestyle parameter II

  9 weeks after the 1st session

Study Arms (2)

PSAI group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

One day seminar where they receive information about stress and lifestyle modifications

Behavioral: One day seminar

Interventions

PSAI BEHAVIORAL

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.

Also known as: Pythagorean Self-Awareness Intervention

PSAI group

One day seminar BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary breast cancer
• Completion of anticancer therapy (except for hormonal therapy)

You may not qualify if:

• Psychiatric diagnosis and treatment
• Metastasis
• Previous participation in any stress management and health promotion study
• Inability to read or write in Greek

Sponsors & Collaborators

• Maria Charalampopoulou: lead
• Hippocration General Hospital: collaborator
• Hellenic Anticancer Institute: collaborator
• Saint Savvas Anticancer Hospital: collaborator

Study Sites (1)

Agios Savvas Hospital

Athens, 11522, Greece

Location

Related Publications (5)

• 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.

  PMID: 19488073 BACKGROUND

• 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.

  PMID: 23941600 BACKGROUND

• 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.

  PMID: 17785865 BACKGROUND

• 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.

  PMID: 31901782 BACKGROUND

• 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.

  PMID: 25367403 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Flora Bacopoulou, MD,PhD

  Aghia Sofia Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 9, 2023
• Study Start: June 4, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the study
• Access Criteria: On request

Locations

GR (1)