Stress Management and Biological Age in Breast Cancer Patients.RCT
- Conditions
- StressBreast CancerTelomere Length, Mean Leukocyte
- Interventions
- Behavioral: PSAIBehavioral: One day seminar
- Registration Number
- NCT05984914
- Lead Sponsor
- Maria Charalampopoulou
- 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, 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.
- 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, 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 & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Diagnosis of primary breast cancer
- Completion of anticancer therapy (except for hormonal therapy)
- Psychiatric diagnosis and treatment
- Metastasis
- Previous participation in any stress management and health promotion study
- Inability to read or write in Greek
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PSAI group PSAI Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 8 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. Control group One day seminar One day seminar where they receive information about stress and lifestyle modifications
- Primary Outcome Measures
Name Time Method Psychological I 9 weeks after the 1st session Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
Psychological II 9 weeks after the 1st session Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)
Physical I 9 weeks after the 1st session Telomere length (measured in mean T/S)
Physical II 9 weeks after the 1st session Hair cortisol levels (measured in pg/mg )
- Secondary Outcome Measures
Name Time Method Physical III 9 weeks after the 1st session Body Composition Analysis (measured in kg and %)
Psychological III 9 weeks after the 1st session QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)
Trial Locations
- Locations (1)
Agios Savvas Hospital
🇬🇷Athens, Greece