- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07769931
Effect of Pecha Kucha-Based Education on Symptom Management and Quality of Life in Patients Receiving Chemotherapy
The Effect of Education Provided Using the PechaKucha Method on Symptom Management and Quality of Life in Patients Receiving Chemotherapy
This randomized controlled study aims to evaluate the effect of education delivered using the PechaKucha method on symptom management and quality of life in patients receiving chemotherapy. Participants will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive individual education on symptom management during chemotherapy using the PechaKucha method. The education will be delivered as a video presentation consisting of 20 visual slides and lasting 6 minutes and 40 seconds. Participants in the control group will receive routine/standard patient education.
Symptom severity and quality of life will be assessed before the education and one week after the intervention using the Edmonton Symptom Assessment System (ESAS) and the EQ-5D. The study will compare changes in symptom severity and quality of life between the intervention and control groups to determine whether PechaKucha-based education is effective in supporting symptom management and quality of life among patients receiving chemotherapy.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
This randomized controlled experimental study is designed to evaluate the effect of education delivered using the PechaKucha method on symptom management and quality of life in patients receiving chemotherapy. The study is being conducted in the Chemotherapy Unit of Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital, with participant enrollment beginning in June 2026.
Participants will be assigned to an intervention group or a control group. Participants in the intervention group will receive individual education on "Symptom Management During Chemotherapy," delivered by the researchers using the PechaKucha method. The educational intervention will be presented as a video consisting of 20 visual slides with a total duration of 6 minutes and 40 seconds. The educational content addresses common chemotherapy-related symptoms and problems, including pain, nausea, anemia, fatigue, diarrhea, constipation, risk of infection, anxiety, depression, mucositis, and alopecia. Participants in the control group will receive routine/standard patient education.
Data will be collected through face-to-face interviews. At baseline, participants in both groups will complete the Patient Information Form, the Edmonton Symptom Assessment System (ESAS), and the EQ-5D. One week after the intervention, the ESAS and EQ-5D will be administered again to participants in both groups. The Patient Information Form, which is used to obtain demographic and clinical information, will be administered only at baseline.
Between-group comparisons will be performed using the independent-samples t-test or Mann-Whitney U test, as appropriate. Within-group pretest-posttest comparisons will be performed using the paired-samples t-test or Wilcoxon signed-rank test, as appropriate. Statistical significance will be set at p < 0.05.
Before participation, individuals will receive written and verbal information about the study, and informed consent will be obtained from all participants.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Asiye TAN, Ph D
- Telefonnummer: 05055675275
- E-post: asiyetan@aydin.edu.tr
Studera Kontakt Backup
- Namn: Dilek YILDIRIM, Ph D
- Telefonnummer: +905331421987
- E-post: dilekyildirim@aydin.edu.tr
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye), 34520
- Rekrytering
- SBÜ Kanuni Sultan Süleyman E.A.H
-
Kontakt:
- Asiye TAN, Ph D
- Telefonnummer: +90 05055675275
- E-post: asiyetan@aydin.edu.tr
-
Kontakt:
- Dilek Yıldırım, Ph D
- Telefonnummer: +90 05331421987
- E-post: dilekyildirim@aydin.edu.tr
-
Underutredare:
- Zülfiye Tosun Öztürkçi, MSc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Willing to participate in the study.
- Currently receiving treatment in the chemotherapy unit.
- Aged 18 years or older, willing to participate, and able to communicate effectively.
Exclusion Criteria:
- Being under 18 years of age.
- Having cognitive or communication difficulties.
- Having a visual or hearing impairment.
- Being in an advanced or terminal stage of the disease.
- Having a physical or psychological condition that prevents active participation in the educational process.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: PechaKucha-Based Education Group
Participants in this arm will receive individual education on "Symptom Management During Chemotherapy" delivered by the researchers using the PechaKucha method.
The education will be provided as a video presentation consisting of 20 visual slides with a total duration of 6 minutes and 40 seconds.
The educational content covers pain, nausea, anemia, fatigue, diarrhea, constipation, risk of infection, anxiety, depression, mucositis, and alopecia.
|
The intervention consists of individual education on symptom management during chemotherapy delivered by the researchers using the PechaKucha method.
The education is provided as a video presentation consisting of 20 visual slides, with each slide displayed for 20 seconds, for a total duration of 6 minutes and 40 seconds.
The educational content addresses pain, nausea, anemia, fatigue, diarrhea, constipation, risk of infection, anxiety, depression, mucositis, and alopecia.
|
|
Aktiv komparator: Routine/Standard Education Group
Participants in this arm will receive routine/standard patient education provided as part of usual care in the chemotherapy unit.
No PechaKucha-based education will be provided to participants in this group.
|
Participants assigned to the control group will receive routine/standard patient education provided as part of usual care in the chemotherapy unit.
This education does not include the PechaKucha-based symptom management education provided to the intervention group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Symptom Severity Assessed by the Edmonton Symptom Assessment System (ESAS)
Tidsram: Baseline (before the intervention) and one week after the intervention
|
The Edmonton Symptom Assessment System (ESAS) will be used to assess symptom severity in patients receiving chemotherapy.
Participants rate the severity of each symptom on a numerical scale, with higher scores indicating greater symptom severity.
The intervention group will receive symptom management education using the PechaKucha presentation format, whereas the control group will receive the same educational content using a conventional teaching method.
Both groups will also receive a brochure summarizing the educational content.
ESAS will be administered to both groups at baseline and one week after the intervention.
Changes in symptom severity from baseline will be compared between the groups.
|
Baseline (before the intervention) and one week after the intervention
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 240/2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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 .