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Stress Management and Biological Age in Breast Cancer Patients.RCT

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05984914
Enrollment
120
Registered
2023-08-09
Start date
2022-06-04
Completion date
2025-09-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Stress, Telomere Length, Mean Leukocyte

Keywords

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

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.

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.

Interventions

BEHAVIORALPSAI

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.

BEHAVIORALOne 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.

Sponsors

Maria Charalampopoulou
Lead SponsorOTHER
Hippocration General Hospital
CollaboratorOTHER
Saint Savvas Anticancer Hospital
CollaboratorOTHER
Hellenic Anticancer Institute
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical I9 weeks after the 1st sessionTelomere length (measured in mean T/S)
Physical II9 weeks after the 1st sessionTotal Oxidant Status. Measured in blood serum. Expected outcome: decrease.
Physical III9 weeks after the 1st sessionBody Composition Analysis (assessed by bio-impedance device)

Secondary

MeasureTime frameDescription
Psychological I9 weeks after the 1st sessionPerceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
Psychological II9 weeks after the 1st sessionSymptoms of anxiety-depression (measured by Hospital Anxiety Depression Scale, expected decrease in mean scores)
Psychological III9 weeks after the 1st sessionConcerns about cancer recurrence (measured by Concerns About Recurrence Scale, expected decrease in means score)
Lifestyle parameter I9 weeks after the 1st sessionAdherence to Mediterrenean Diet (measured by MedDiet, expected increase in means score)
Lifestyle parameter II9 weeks after the 1st sessionAdherence to a Healthy Lifestyle (measured by Healthy Lifestyle and Personal Control Questionnaire, expected increase in means score)
Lifestyle parameter III9 weeks after the 1st sessionSleep quality (measured by Pittsburgh Sleep Quality Index, expected decrease in means score)
Lifestyle parameter IV9 weeks after the 1st sessionPhysical activity (measured by International Physical Activity Questionnaire -7, expected increase in METs/week)

Countries

Greece

Contacts

STUDY_DIRECTORFlora Bacopoulou, MD,PhD

Aghia Sofia Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026