Stress Management and Biological Age in Breast Cancer Patients.RCT

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984914
• Other study ID #: 2513
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: National and Kapodistrian University of Athens
• Contact: Maria Charalampopoulou, PT, CDT, MSc
• Phone: +306949614342
• Email: maria.charalampopoulou[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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, collecting hair cortisol samples, and extracting genetic (DNA) material to study the telomere length of T-cells from peripheral blood.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stress
• Telomere Length, Mean Leukocyte

Intervention

Behavioral:
• PSAI
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.
• One 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.

Locations

Country	Name	City	State
Greece	Agios Savvas Hospital	Athens

Sponsors (4)

Lead Sponsor	Collaborator
Maria Charalampopoulou	Hellenic Anticancer Institute, Hippocration General Hospital, Saint Savvas Anticancer Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological I	Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)	9 weeks after the 1st session
Primary	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
Primary	Physical I	Telomere length (measured in mean T/S)	9 weeks after the 1st session
Primary	Physical II	Hair cortisol levels (measured in pg/mg )	9 weeks after the 1st session
Secondary	Physical III	Body Composition Analysis (measured in kg and %)	9 weeks after the 1st session
Secondary	Psychological III	QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)	9 weeks after the 1st session