NCT05984914

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, 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

July 23, 2023

Last Update Submit

August 2, 2023

Conditions

StressBreast CancerTelomere Length, Mean Leukocyte

Keywords

StressBreast CancerLifestyleStress managementTelomeresBiological agePSAI

Outcome Measures

Primary Outcomes (4)

  • 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-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)

    9 weeks after the 1st session

  • Physical I

    Telomere length (measured in mean T/S)

    9 weeks after the 1st session

  • Physical II

    Hair cortisol levels (measured in pg/mg )

    9 weeks after the 1st session

Secondary Outcomes (2)

  • Physical III

    9 weeks after the 1st session

  • Psychological III

    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 8 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

PSAIBEHAVIORAL

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.

Also known as: Pythagorean Self-Awareness Intervention
PSAI group
One day seminarBEHAVIORAL

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

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agios Savvas Hospital

Athens, 11522, Greece

RECRUITING

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: 19488073BACKGROUND

  • 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: 23941600BACKGROUND

  • 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: 17785865BACKGROUND

  • 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: 31901782BACKGROUND

  • 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: 25367403BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Flora Bacopoulou, MD,PhD

    Aghia Sofia Hospital

    STUDY DIRECTOR

Central Study Contacts

Maria Charalampopoulou, PT, CDT, MSc

CONTACT

+306949614342maria.charalampopoulou@outlook.com

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

January 4, 2021

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publication of the study
Access Criteria
On request

Locations

GR(1)