- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07828119
The Effect of a Hybrid Approach in Breast Cancer Education on Women's Awareness, Fatalism, and Self-Compassion Levels: A Randomized Controlled Trial
15 september 2026 uppdaterad av: Emine Aksut Akcay, Kahramanmaras Sutcu Imam University
This randomized controlled trial aims to evaluate the effect of a hybrid breast cancer education program on women's breast cancer awareness, cancer fatalism, and self-compassion levels.
The study will include 128 women aged 20-65 who apply to an obstetrics and gynecology outpatient clinic.
Participants will be randomly assigned to either an experimental group or a control group.
The experimental group will receive a hybrid education model.
This model consists of a face-to-face training session using a breast model, followed by four weeks of educational materials, informative messages, and reminders delivered via a mobile application.
The control group will receive routine healthcare services without this specific educational intervention.
Researchers will measure the participants' levels of self-compassion, breast cancer fatalism, and breast cancer awareness using standardized questionnaires.
These measurements will be taken at the beginning of the study (pre-test) and four weeks later (post-test) to determine if the technology-supported hybrid education model is effective in improving early diagnosis awareness and psychosocial outcomes
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Breast cancer remains the most common cancer among women globally, making early detection and screening programs a primary target for public health policies.
However, insufficient awareness and high levels of cancer fatalism can negatively impact women's participation in early diagnosis behaviors such as breast self-examination and mammography.
Additionally, self-compassion is an emerging concept in women's health associated with better psychological resilience, stress management, and adherence to health behaviors.
While digital technologies have transformed health education through hybrid models, there is a limited number of randomized controlled trials examining the combined effects of hybrid education approaches on awareness, fatalism, and self-compassion in community-based female populations.
This study is designed to address this gap in the literature.
The sample size was determined using a priori power analysis via G*Power software (MANOVA: Repeated measures, within-between interaction), calculating a minimum of 128 participants based on an effect size of f(V)=0.25,
α=0.05, and test power of 0.80.
Statistical analysis will be conducted using SPSS software.
Following normality checks via Kolmogorov-Smirnov tests and the evaluation of skewness and kurtosis coefficients, group comparisons will be performed using appropriate parametric (e.g., Independent Samples t-test) or non-parametric (e.g., Mann-Whitney U, Wilcoxon signed-rank test) statistical methods.
A p-value of <0.05 will be considered statistically significant.
Studietyp
Interventionell
Inskrivning (Beräknad)
128
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Emine A AKSÜT AKÇAY, Assistant Professor
- Telefonnummer: 0553594 52 60
- E-post: emineaksutakcay@ksu.edu.tr/
Studera Kontakt Backup
- Namn: Hülya KAMALAK, Master's Student
- Telefonnummer: 0553594 52 60
- E-post: hulyakoca31@windowslive.com
Studieorter
-
-
Merkez
-
Kahramanmaraş, Merkez, Turkiet (Türkiye), 46040
- Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Being between 20 and 65 years of age
- Being female
- Agreeing to participate in the study and signing the informed consent form
- Having no prior diagnosis of breast cancer
- Having the ability to use a mobile application
Exclusion Criteria:
- Having a prior diagnosis of breast cancer or active breast pathology
- Having any cognitive, mental, or communication barrier that prevents participation in training
- Refusing to participate or withdraw consent during the study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Hybrid Breast Cancer Education Group
The experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period.
|
The experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period
|
|
Inget ingripande: Control Group
Participants in the control group will not receive the hybrid breast cancer education intervention during the study period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Breast Cancer Awareness Score
Tidsram: Baseline and 4 weeks post-intervention
|
Change in participants' breast cancer awareness scores from baseline to 4 weeks post-intervention.
|
Baseline and 4 weeks post-intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 september 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
3 september 2026
Först inskickad som uppfyllde QC-kriterierna
15 september 2026
Första postat (Faktisk)
18 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- KSU-TAREK-244
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical approval terms.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .