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StressNCT05984914

Stress Management and Biological Age in Breast Cancer Patients.RCT

A study testing PSAI and One day seminar in people with Stress and Breast Cancer, run by Maria Charalampopoulou at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
PSAI and One day seminar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGreece
Study dates
4 Jun 2022to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Agios Savvas Hospital

    Athens, 11522

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Being tested
PSAI, One day seminar
Keywords
Stress, Breast Cancer, Lifestyle, Stress management, Telomeres, Biological age, PSAI
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSAIBehavioural

    Also called Pythagorean Self-Awareness Intervention

    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.

  • One day seminarBehavioural

    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.

Study groups in NCT05984914
Study groupRoleWhat they receive
PSAI groupExperimentalParticipants 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.
Receives: Behavioral: PSAI
Control groupActive comparatorOne day seminar where they receive information about stress and lifestyle modifications
Receives: Behavioral: One day seminar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical I

    Telomere length (measured in mean T/S)

    Measured: 9 weeks after the 1st session

  2. Physical II

    Total Oxidant Status. Measured in blood serum. Expected outcome: decrease.

    Measured: 9 weeks after the 1st session

  3. Physical III

    Body Composition Analysis (assessed by bio-impedance device)

    Measured: 9 weeks after the 1st session

Secondary outcomes (7)

  1. Psychological I

    Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)

    Measured: 9 weeks after the 1st session

  2. Psychological II

    Symptoms of anxiety-depression (measured by Hospital Anxiety Depression Scale, expected decrease in mean scores)

    Measured: 9 weeks after the 1st session

  3. Psychological III

    Concerns about cancer recurrence (measured by Concerns About Recurrence Scale, expected decrease in means score)

    Measured: 9 weeks after the 1st session

  4. Lifestyle parameter I

    Adherence to Mediterrenean Diet (measured by MedDiet, expected increase in means score)

    Measured: 9 weeks after the 1st session

  5. Lifestyle parameter II

    Adherence to a Healthy Lifestyle (measured by Healthy Lifestyle and Personal Control Questionnaire, expected increase in means score)

    Measured: 9 weeks after the 1st session

  6. Lifestyle parameter III

    Sleep quality (measured by Pittsburgh Sleep Quality Index, expected decrease in means score)

    Measured: 9 weeks after the 1st session

  7. Lifestyle parameter IV

    Physical activity (measured by International Physical Activity Questionnaire -7, expected increase in METs/week)

    Measured: 9 weeks after the 1st session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start4 Jun 2022
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984914
Sponsor's protocol ID
2513
Status last verified
May 2026
First submitted
23 Jul 2023
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • 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.

    PubMed 19488073

  • 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.

    PubMed 23941600

  • 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.

    PubMed 17785865

  • 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.

    PubMed 31901782

  • 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.

    PubMed 25367403

Questions about this trial

What is this clinical trial studying?

A study testing PSAI and One day seminar in people with Stress and Breast Cancer, run by Maria Charalampopoulou at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical I (time frame: 9 weeks after the 1st session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05984914, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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