Breast Cancer Patients Receiving ChemotherapyMindfulnessNCT06183164
Awareness Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy
A study testing Mindfulness: Awareness-Based Stress Reduction Program in people with Breast Cancer Patients Receiving Chemotherapy, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Patients Receiving Chemotherapy
- What is being tested?
- Mindfulness: Awareness-Based Stress Reduction Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who have communication problems
- Those with psychiatric problems
- Not agreeing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Mindfulness: Awareness-Based Stress Reduction Program
- Keywords
- life quality mindfulness psychological resilience symptom management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness: Awareness-Based Stress Reduction ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mindfulness: Awareness-Based Stress Reduction Program |
| Control group | No intervention | Routine main tenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of Sessions 16 ( each Session 1 days a week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start29 Oct 2023
- Primary completion29 May 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients Receiving ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an exprimental study with pre-test, intermediate test and post-test control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183164
- Sponsor's protocol ID
- 08/06/2023
- Acronym
- Mindfulness
- Status last verified
- Apr 2025
- First submitted
- 30 Nov 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06183164
- Acronym / sponsor ID
- Mindfulness / 08/06/2023
- Keywords
- life quality mindfulness psychological resilience symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 29 Oct 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an exprimental study with pre-test, intermediate test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Other: Mindfulness: Awareness-Based Stress Reduction ProgramThe 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. |
| Control group | No intervention | –Routine main tenance will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Those who have communication problems
- Those with psychiatric problems
- Not agreeing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness: Awareness-Based Stress Reduction ProgramThe 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. | Other | Mindfulness |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness: Awareness-Based Stress Reduction Program in people with Breast Cancer Patients Receiving Chemotherapy, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESTO SYMPTOM DIAGNOSIS SCALE (time frame: At the end of Sessions 16 ( each Session 1 days a week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.