Skip to main content
OpenTrials
Completed

NCT Number: NCT05984914

Stress Management and Biological Age in Breast Cancer Patients.RCT

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Telomere Length, Mean Leukocyte

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Agios Savvas Hospital

Athens, 11522, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pythagorean Self-Awareness Intervention

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.

Primary outcomes

  1. Physical I

    Time frame: 9 weeks after the 1st session

    Telomere length (measured in mean T/S)

  2. Physical II

    Time frame: 9 weeks after the 1st session

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

  3. Physical III

    Time frame: 9 weeks after the 1st session

    Body Composition Analysis (assessed by bio-impedance device)

Secondary outcomes

  1. Psychological I

    Time frame: 9 weeks after the 1st session

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

  2. Psychological II

    Time frame: 9 weeks after the 1st session

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

  3. Psychological III

    Time frame: 9 weeks after the 1st session

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

  4. Lifestyle parameter I

    Time frame: 9 weeks after the 1st session

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

  5. Lifestyle parameter II

    Time frame: 9 weeks after the 1st session

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

  6. Lifestyle parameter III

    Time frame: 9 weeks after the 1st session

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

  7. Lifestyle parameter IV

    Time frame: 9 weeks after the 1st session

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

Sponsors and collaborators

Lead sponsor

Maria Charalampopoulou

Other

Collaborators

  • Hellenic Anticancer Institute
  • Hippocration General Hospital
  • Saint Savvas Anticancer Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.