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Completed

NCT Number: NCT06183164

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

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.

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Key information

Conditions

Breast Cancer Patients Receiving Chemotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Acronym: Mindfulness

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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