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

NCT06183164 | Completed

• 1 other identifier: 08/06/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Patients Receiving Chemotherapy

Keywords

life quality mindfulness psychological resilience symptom management

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Control group

NO INTERVENTION

Routine main tenance will be applied.

Interventions

Mindfulness: Awareness-Based Stress Reduction Program OTHER

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.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is an exprimental study with pre-test, intermediate test and post-test control groups.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 27, 2023
• Study Start: October 29, 2023
• Primary Completion: May 29, 2024
• Study Completion: July 29, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)