Awareness Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy (Mindfulness)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Patients Receiving Chemotherapy
• Intervention / Treatment: Other: Mindfulness: Awareness-Based Stress Reduction Program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Center
    • Elazığ, Center, Turkey, 25240
      • Fırat university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; The program lasts eight weeks, with face-to-face group meetings for 2-2.5 hours per week and applications requested from the patient. It is a program in which various mindfulness practices are used consecutively for eight weeks and completed with a six-hour silence (retreat) day at the end of the eight weeks.	Other: Mindfulness: Awareness-Based Stress Reduction Program; The mindfulness-based stress reduction program was applied to the patients in the experimental group once a week, for 150 minutes, for 8 weeks and 8 times in total. Then, an intermediate test is applied to the patients. After the interim test, patients are asked to repeat the mindfulness-based stress reduction program individually for 8 weeks (between weeks 8-16). In addition, after the conscious awareness-based stress reduction program is applied to the patients in the experimental group by the researcher, the 'Conscious Awareness-Based Stress Reduction Program' booklet prepared by the researcher is given to the patients as a guide. experimental group.
No Intervention: Control group; Routine main tenance will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESTO SYMPTOM DIAGNOSIS SCALE	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.	At the end of Sessions 16 ( each Session 1 days a week)
EORTC QLQ-C 30 Quality of Life Scale	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.	At the end of Sessions 16 ( each Session 1 days a week)
Brief Psychological Resilience Scale	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.	At the end of Sessions 16 ( each Session 1 days a week)

Collaborators and Investigators

• Sponsor: Firat University

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2023
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: life quality mindfulness psychological resilience symptom management
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 08/06/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No