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Stress Management and Biological Age in Breast Cancer Patients.RCT

Primary Purpose

Stress, Breast Cancer, Telomere Length, Mean Leukocyte

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
PSAI
One day seminar
Sponsored by
Maria Charalampopoulou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring Stress, Breast Cancer, Lifestyle, Stress management, Telomeres, Biological age, PSAI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Agios Savvas HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PSAI group

Control group

Arm Description

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.

One day seminar where they receive information about stress and lifestyle modifications

Outcomes

Primary Outcome Measures

Psychological I
Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
Psychological II
Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)
Physical I
Telomere length (measured in mean T/S)
Physical II
Hair cortisol levels (measured in pg/mg )

Secondary Outcome Measures

Physical III
Body Composition Analysis (measured in kg and %)
Psychological III
QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)

Full Information

First Posted
July 23, 2023
Last Updated
August 2, 2023
Sponsor
Maria Charalampopoulou
Collaborators
Hippocration General Hospital, Saint Savvas Anticancer Hospital, Hellenic Anticancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05984914
Brief Title
Stress Management and Biological Age in Breast Cancer Patients.RCT
Official Title
Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Charalampopoulou
Collaborators
Hippocration General Hospital, Saint Savvas Anticancer Hospital, Hellenic Anticancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Breast Cancer, Telomere Length, Mean Leukocyte
Keywords
Stress, Breast Cancer, Lifestyle, Stress management, Telomeres, Biological age, PSAI

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSAI group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
One day seminar where they receive information about stress and lifestyle modifications
Intervention Type
Behavioral
Intervention Name(s)
PSAI
Other Intervention Name(s)
Pythagorean Self-Awareness Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
One day seminar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychological I
Description
Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
Time Frame
9 weeks after the 1st session
Title
Psychological II
Description
Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)
Time Frame
9 weeks after the 1st session
Title
Physical I
Description
Telomere length (measured in mean T/S)
Time Frame
9 weeks after the 1st session
Title
Physical II
Description
Hair cortisol levels (measured in pg/mg )
Time Frame
9 weeks after the 1st session
Secondary Outcome Measure Information:
Title
Physical III
Description
Body Composition Analysis (measured in kg and %)
Time Frame
9 weeks after the 1st session
Title
Psychological III
Description
QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)
Time Frame
9 weeks after the 1st session

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Charalampopoulou, PT, CDT, MSc
Phone
+306949614342
Email
maria.charalampopoulou@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flora Bacopoulou, MD,PhD
Organizational Affiliation
Aghia Sofia Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Agios Savvas Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrios Tryfonopoulos, MD,PhD
Phone
+306932669110
Email
oncology2@agsavvas-hosp.grm
First Name & Middle Initial & Last Name & Degree
Maria Charalampopoulou, PT, CDT, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
After publication of the study
IPD Sharing Access Criteria
On request
Citations:
PubMed Identifier
19488073
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.
Results Reference
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PubMed Identifier
23941600
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.
Results Reference
background
PubMed Identifier
17785865
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.
Results Reference
background
PubMed Identifier
31901782
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.
Results Reference
background
PubMed Identifier
25367403
Citation
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.
Results Reference
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Stress Management and Biological Age in Breast Cancer Patients.RCT

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