v6.11_prescreener_study(please don't touch)

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    100
  • sponsor
    pfizer
Updated on 19 February 2024
Accepts healthy volunteers

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.

Details
Condition Alzheimer's Disease, Acne
Age 10-99 years
Clinical Study IdentifierTX13158
Sponsorpfizer
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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