Breast CancerNCT07731477
The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy
A study testing VR-Based Mindfulness Intervention in people with Breast Cancer and Chemotherapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Chemotherapy
- What is being tested?
- VR-Based Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed with breast cancer, Female and aged 18 years or older, Diagnosed with stage II or III breast cancer, Scheduled to receive chemotherapy for breast cancer for the first time in the adjuvant or neoadjuvant setting, using either the CA regimen [C: cyclophosphamide; A: doxorubicin (Adriamycin)] or the TC regimen [T: docetaxel; C: cyclophosphamide], with or without paclitaxel, trastuzumab, docetaxel, or carboplatin, Scheduled to receive chemotherapy but have not yet started treatment, Have a Beck Depression Inventory (BDI) score of ≤30, have no physician-diagnosed psychiatric disorder according to the DSM-5 diagnostic criteria, and are not receiving treatment for a psychiatric disorder (Appendix 8), Have completed at least primary school education, Voluntarily agree to participate in the study.
Who cannot join
- Presence of metastasis, History of seizures, Presence of vertigo, Presence of motion sickness with a tendency toward nausea and vomiting, Communication difficulties, including hearing, visual, or speech impairments, Unwillingness to participate in the study. Withdrawal Criteria
- Participants will be withdrawn from the study if:
- They discontinue the treatment protocol at any stage, Their treatment protocol is changed, They no longer wish to continue participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital, Ministry of Health, Republic of Turkey
Ankara, Ankara, 06830
GİZEM CANSIZ UÇAR, Registered Nurse, +905342396480, gizem.cansiz@atilim.edu.tr
About this study
Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions.
Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients.
Read more
The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT).
The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study.
According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group.
The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale.
It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.
- Conditions
- Breast Cancer, Chemotherapy
- Being tested
- VR-Based Mindfulness Intervention
- Keywords
- Breast cancer, chemotherapy, Mindfulness, Virtual Reality
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Based Mindfulness InterventionBehavioural
The mindfulness intervention content was developed collaboratively by the research team and a mindfulness expert, based on a literature-informed design tailored to the study's aims and target population. Among the researchers, GCU has completed training in Mindfulness-Based Stress Reduction (MBSR), simulation-based practice, and has prior experience working with breast cancer patients. The mindfulness expert (EU), a licensed medical doctor, holds certifications in Mindfulness Teaching (Bangor University, UK), Professional Coaching (CTI), and the Mindfulness in Schools Project (UK). To align with the study objectives, mindfulness contents addressing anxiety, comfort, sleep, and fatigue were created by the team and the expert.
| Study group | Role | What they receive |
|---|---|---|
| VR-Mindfulness Intervention Group | Experimental | Participants in this group will receive the Virtual Reality-Based Mindfulness program in addition to standard care during chemotherapy sessions. Receives: Behavioral: VR-Based Mindfulness Intervention |
| Control Group | No intervention | Participants in this group will receive standard nursing care and routine chemotherapy without the VR-Mindfulness program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessed Using the Cancer Fatigue Scale
Fatigue will be assessed using the Cancer Fatigue Scale. The 15-item scale produces a total score ranging from 0 to 60. Higher scores indicate greater fatigue severity.
Measured: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Comfort Assessed Using the General Comfort Questionnaire-Short Form
Comfort will be assessed using the General Comfort Questionnaire-Short Form. The 28-item scale produces a total score ranging from 28 to 168. Higher scores indicate a higher level of comfort.
Measured: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Sleep Quality Assessed Using the Jenkins Sleep Scale
Sleep quality will be assessed using the Jenkins Sleep Scale. The four-item scale produces a total score ranging from 0 to 20. Higher scores indicate more frequent sleep problems and poorer sleep quality.
Measured: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Anxiety Assessed Using the State-Trait Anxiety Inventory-State Anxiety Subscale
Anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. The 20-item subscale produces a total score ranging from 20 to 80. Higher scores indicate greater state anxiety.
Measured: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Mindfulness-Based Self-Efficacy Assessed Using the Mindfulness-Based Self-Efficacy Scale-Revised
Mindfulness-based self-efficacy will be assessed using the 22-item Mindfulness-Based Self-Efficacy Scale-Revised. The mean score ranges from 0 to 4. Higher scores indicate greater mindfulness-based self-efficacy.
Measured: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Oct 2025
- Primary completion1 Jul 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 designed as a randomized controlled trial with a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a Virtual Reality-Based Mindfulness program during chemotherapy sessions, or the control group, which will receive standard care. Outcomes will be assessed before, during, and after the intervention period
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Cansiz Ucar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731477
- Sponsor's protocol ID
- 2024-12/890
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to privacy and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07731477
- Acronym / sponsor ID
- 2024-12/890
- Conditions
- Breast Cancer, Chemotherapy
- Keywords
- Breast cancer, chemotherapy, Mindfulness, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions.
Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients.
The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT).
The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study.
According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group.
The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale.
It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized controlled trial with a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a Virtual Reality-Based Mindfulness program during chemotherapy sessions, or the control group, which will receive standard care. Outcomes will be assessed before, during, and after the intervention period
| Arm | Type | Receives |
|---|---|---|
| VR-Mindfulness Intervention Group | Experimental | Behavioral: VR-Based Mindfulness InterventionParticipants in this group will receive the Virtual Reality-Based Mindfulness program in addition to standard care during chemotherapy sessions. |
| Control Group | No intervention | –Participants in this group will receive standard nursing care and routine chemotherapy without the VR-Mindfulness program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed with breast cancer, Female and aged 18 years or older, Diagnosed with stage II or III breast cancer, Scheduled to receive chemotherapy for breast cancer for the first time in the adjuvant or neoadjuvant setting, using either the CA regimen [C: cyclophosphamide; A: doxorubicin (Adriamycin)] or the TC regimen [T: docetaxel; C: cyclophosphamide], with or without paclitaxel, trastuzumab, docetaxel, or carboplatin, Scheduled to receive chemotherapy but have not yet started treatment, Have a Beck Depression Inventory (BDI) score of ≤30, have no physician-diagnosed psychiatric disorder according to the DSM-5 diagnostic criteria, and are not receiving treatment for a psychiatric disorder (Appendix 8), Have completed at least primary school education, Voluntarily agree to participate in the study.
Key exclusion criteria (3 listed)
- Presence of metastasis, History of seizures, Presence of vertigo, Presence of motion sickness with a tendency toward nausea and vomiting, Communication difficulties, including hearing, visual, or speech impairments, Unwillingness to participate in the study. Withdrawal Criteria
- They discontinue the treatment protocol at any stage, Their treatment protocol is changed, They no longer wish to continue participating 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 |
|---|---|---|
| VR-Based Mindfulness InterventionThe mindfulness intervention content was developed collaboratively by the research team and a mindfulness expert, based on a literature-informed design tailored to the study's aims and target population. Among the researchers, GCU has completed training in Mindfulness-Based Stress Reduction (MBSR), simulation-based practice, and has prior experience working with breast cancer patients. The mindfulness expert (EU), a licensed medical doctor, holds certifications in Mindfulness Teaching (Bangor University, UK), Professional Coaching (CTI), and the Mindfulness in Schools Project (UK). To align with the study objectives, mindfulness contents addressing anxiety, comfort, sleep, and fatigue were created by the team and the expert. | Behavioural | VR-Mindfulness Intervention Group |
Primary outcome
Fatigue Assessed Using the Cancer Fatigue Scale
Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Fatigue will be assessed using the Cancer Fatigue Scale. The 15-item scale produces a total score ranging from 0 to 60. Higher scores indicate greater fatigue severity.
Comfort Assessed Using the General Comfort Questionnaire-Short Form
Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Comfort will be assessed using the General Comfort Questionnaire-Short Form. The 28-item scale produces a total score ranging from 28 to 168. Higher scores indicate a higher level of comfort.
Sleep Quality Assessed Using the Jenkins Sleep Scale
Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Sleep quality will be assessed using the Jenkins Sleep Scale. The four-item scale produces a total score ranging from 0 to 20. Higher scores indicate more frequent sleep problems and poorer sleep quality.
Anxiety Assessed Using the State-Trait Anxiety Inventory-State Anxiety Subscale
Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. The 20-item subscale produces a total score ranging from 20 to 80. Higher scores indicate greater state anxiety.
Mindfulness-Based Self-Efficacy Assessed Using the Mindfulness-Based Self-Efficacy Scale-Revised
Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Mindfulness-based self-efficacy will be assessed using the 22-item Mindfulness-Based Self-Efficacy Scale-Revised. The mean score ranges from 0 to 4. Higher scores indicate greater mindfulness-based self-efficacy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to privacy and ethical considerations.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Mindfulness Intervention in people with Breast Cancer and Chemotherapy, run by Hacettepe 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 1 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GİZEM CANSIZ UÇAR, Registered Nurse (+905342396480, gizem.cansiz@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessed Using the Cancer Fatigue Scale (time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.). The study lists 5 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 28 Jul 2026.