The Effect of Video-Assisted Mindfulness-Based Breathing on Quality of Life and Mental Well-Being in Individuals With Breast Cancer
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.
In 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.
Outcomes 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Mindfulness-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.
Although 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.
This 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.
The control group will receive routine clinical care without additional intervention. Data will be collected at baseline and after the 6-week intervention period.
The 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).
This 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: gözde koçak
- Telefonnummer: +905419129438
- E-post: gozde.kocakk@outlook.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Diagnosed 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
✔ 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Group
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.
|
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.
|
|
Ingen inngripen: Control Group
Participants will receive routine clinical care without any additional intervention during the study period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quality of Life
Tidsramme: Baseline and 6 weeks after randomization
|
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
|
|
Change in Mental Well-Being
Tidsramme: Baseline and 6 weeks after randomization
|
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.
|
Baseline and 6 weeks after randomization
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GK-MB-BREAST-RCT-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .