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Clinical Trials/NCT06183164
NCT06183164
Completed
Not Applicable

The Effect of Awareness-Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy on Symptom Management Psychological Resilience and Quality of Life

Firat University1 site in 1 country60 target enrollmentOctober 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Patients Receiving Chemotherapy
Sponsor
Firat University
Enrollment
60
Locations
1
Primary Endpoint
ESTO SYMPTOM DIAGNOSIS SCALE
Status
Completed
Last Updated
last year

Overview

Brief Summary

Implementation of awareness-based stress reduction program in breast cancer patients receiving chemotherapy and examining its effects on psychological resilience, symptom management and quality of life.

Detailed Description

The conscious awareness-based stress reduction program is a program that lasts eight weeks, each session lasting 2-2.5 hours and including a 6-hour silence day. In order to apply the mindfulness stress reduction program to the experimental group, the 'Conscious Awareness Stress Reduction Program day and time were determined for 30 breast cancer patients receiving chemotherapy who met the inclusion criteria and were sampled. It was applied to the patients in the experimental group, once a week for 150 minutes, lasting 8 weeks, and consisting of 8 times in total. Then, an intermediate test was applied to the patients. After the interim test, patients were asked to repeat the It applications individually for 8 weeks (between weeks 8-16). In addition, after It was applied to the patients in the experimental group by the researcher, the 'Conscious Awareness Stress Reduction Program booklet prepared by the researcher was given to the patients in order to provide a guide for the patients in the experimental group. During the implementation of the research, no intervention was applied to the control group.

Registry
clinicaltrials.gov
Start Date
October 29, 2023
End Date
July 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Firat University
Responsible Party
Principal Investigator
Principal Investigator

Gülcan Bahçecioğlu Turan

Principal Investigator

Firat University

Eligibility Criteria

Inclusion Criteria

  • Being over 18 years of age
  • Ability to communicate adequately
  • No psychiatric problems
  • Implementation of the Awareness-Based Stress Reduction Program is an obstacle
  • Volunteering to participate in the research

Exclusion Criteria

  • Those who have communication problems
  • Those with psychiatric problems
  • Not agreeing to participate in the study.

Outcomes

Primary Outcomes

ESTO SYMPTOM DIAGNOSIS SCALE

Time Frame: At the end of Sessions 16 ( each Session 1 days a week)

The scale includes problems such as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling of well-being and shortness of breath. The severity of each symptom is evaluated with numerical scores from 0 to 10. The most important rule in evaluating the symptom is that the patient marks the number indicating the severity of the symptom according to his/her own statement. The patient is asked to match the symptoms he/she experiences with a number between 0-10 that he/she thinks best fits him/her. A score of 0 on the scale indicates that there is no symptom, while a score of 10 indicates that the symptom is experienced very severely.

Brief Psychological Resilience Scale

Time Frame: At the end of Sessions 16 ( each Session 1 days a week)

It is a 5-point Likert type, 6-item, self-report measurement tool. It has an answer key of "Not at all appropriate" (1), "Not Applicable" (2), "Somewhat Appropriate" (3), "Appropriate" (4), "Completely Appropriate". Items 2, 4, and 6 in the scale are reverse coded. High scores obtained after translating the reverse coded items indicate a high level of psychological resilience.

EORTC QLQ-C 30 Quality of Life Scale

Time Frame: At the end of Sessions 16 ( each Session 1 days a week)

It consists of 30 questions with three subscales: general well-being (questions 29, 30), functional difficulties (questions 1-7, 20-27) and symptom control (questions 8-19 and 28). The first 28 items in the scale are four-point Likert. Not at all: 1, A little: 2, Quite a bit: 3, A lot: 4 points. These items are questions regarding symptoms and functional domain. Low scores on these items indicate high quality of life, while high scores indicate low quality of life.

Study Sites (1)

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