[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640400":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":27,"studyPopulation":16,"armGroups":28,"interventions":39,"overallOfficials":16,"centralContacts":45,"locations":16,"responsibleParty":51,"collaborators":16,"id":55,"slug":16,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":16,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":16,"enrollmentInfo":62,"targetDuration":16,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":16,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":16},{"fullName":5,"class":6},"Ege University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Quality of Life","Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the breast cancer-specific module (EORTC QLQ-BR23). Scores range from 0 to 100. Higher scores on global health status and functional scales indicate better quality of life, while higher scores on symptom scales indicate greater symptom burden.","Baseline and 6 weeks after randomization",{"measure":14,"description":15,"timeFrame":12},"Change in Mental Well-Being","Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale includes 14 positively worded items scored on a 5-point Likert scale. Total scores range from 14 to 70, with higher scores indicating higher mental well-being.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to either an intervention group receiving video-assisted mindfulness-based breathing or a control group receiving routine care.","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":24,"whoMasked":25},"SINGLE","The outcome assessor will be blinded to group allocation. Participants and intervention providers will not be blinded due to the nature of the intervention.",[26],"OUTCOMES_ASSESSOR","Breast cancer is one of the most common malignancies worldwide and represents a significant public health burden. Individuals diagnosed with breast cancer frequently experience a wide range of physical and psychological challenges, including fatigue, pain, anxiety, depression, and decreased quality of life. These challenges may persist during and after treatment, highlighting the need for supportive and integrative care approaches.\n\nMindfulness-based interventions have gained increasing attention in oncology care due to their potential to improve psychological well-being and quality of life. Among these approaches, mindfulness-based breathing is a simple, non-invasive, and cost-effective method that focuses on increasing awareness of the present moment through controlled breathing. This practice may enhance parasympathetic nervous system activity and help reduce stress and anxiety.\n\nAlthough mindfulness-based interventions have been studied in cancer populations, there is limited evidence specifically focusing on structured, video-assisted mindfulness-based breathing interventions in individuals with breast cancer. Therefore, this study aims to evaluate the effectiveness of a video-assisted mindfulness-based breathing program on quality of life and mental well-being in breast cancer patients.\n\nThis study is designed as a randomized controlled, single-blind clinical trial. A total of 50 participants diagnosed with breast cancer will be randomly assigned to either an intervention group (n=25) or a control group (n=25). The intervention group will receive a face-to-face training session on mindfulness-based breathing, followed by a 6-week daily practice supported by a 5-minute instructional video delivered through an online platform. Adherence to the intervention will be monitored through digital tracking systems and weekly follow-ups.\n\nThe control group will receive routine clinical care without additional intervention. Data will be collected at baseline and after the 6-week intervention period.\n\nThe primary outcomes of the study are quality of life and mental well-being. Quality of life will be assessed using the EORTC QLQ-C30 and EORTC BR23 scales, and mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).\n\nThis study aims to contribute to the literature by providing evidence on a standardized, video-assisted mindfulness-based breathing intervention tailored for individuals with breast cancer. The findings are expected to support the integration of non-pharmacological, accessible, and cost-effective interventions into oncology care and nursing practice.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Experimental Group","EXPERIMENTAL","Participants will receive video-assisted mindfulness-based breathing training, including a face-to-face session followed by daily 5-minute guided breathing exercises for 6 weeks.",[34],"Behavioral: Mindfulness-Based Breathing",{"label":36,"type":37,"description":38,"interventionNames":16},"Control Group","NO_INTERVENTION","Participants will receive routine clinical care without any additional intervention during the study period.",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":16},"BEHAVIORAL","Mindfulness-Based Breathing","A structured mindfulness-based breathing program consisting of an initial face-to-face training session followed by a 6-week daily video-guided breathing practice delivered through an online platform.",[30],[46],{"name":47,"role":48,"phone":49,"phoneExt":16,"email":50},"gözde koçak","CONTACT","+905419129438","gozde.kocakk@outlook.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Gözde Koçak","Research Assistant","100640400",false,"NCT07575386","The Effect of Video-Assisted Mindfulness-Based Breathing on Quality of Life and Mental Well-Being in Individuals With Breast Cancer","Inclusion Criteria:\n\nDiagnosed with breast cancer Aged 18 years or older Stage I, II, or III breast cancer Completed at least 4 cycles of chemotherapy Completed chemotherapy treatment Able to understand and speak Turkish Has access to a digital device (smartphone, tablet, or computer) Willing to participate in the study\n\n✔ Exclusion Criteria: Diagnosis of another type of cancer Presence of psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression, anxiety disorders) Stage IV breast cancer Presence of respiratory problems Previous or current experience with yoga or meditation Refusal to participate in the study","ALL","18 Years",{"count":63,"type":64},50,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study aims to evaluate the effect of video-assisted mindfulness-based breathing on quality of life and mental well-being in individuals with breast cancer. Breast cancer patients often experience physical and psychological challenges that negatively affect their quality of life. Mindfulness-based breathing is a simple, non-invasive method that may help reduce stress and improve well-being.\n\nIn this randomized controlled study, participants will be assigned to either an intervention group or a control group. The intervention group will receive a face-to-face breathing training session and will practice daily mindfulness-based breathing exercises using a 5-minute video for 6 weeks. The control group will receive routine care.\n\nOutcomes will be measured at baseline and after 6 weeks using validated scales assessing quality of life and mental well-being. This study aims to provide evidence for a simple and accessible supportive care method for individuals with breast cancer.",[70],"Breast Cancer",[70,72,73,74],"Mindfulness","Quality of Life","Mental Well-being","NOT_YET_RECRUITING","2026-05-02",{"date":78,"type":79},"2026-05-08","ACTUAL",{"date":81,"type":64},"2026-09-02",{"date":83,"type":64},"2027-06-02",{"name":5,"class":6}]