Breast Cancer Clinical Trial
Official title:
Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.
NCT number | NCT05984914 |
Other study ID # | 2513 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2021 |
Est. completion date | January 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Agios Savvas Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Maria Charalampopoulou | Hellenic Anticancer Institute, Hippocration General Hospital, Saint Savvas Anticancer Hospital |
Greece,
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
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 |
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