NCT Number: NCT07061236
Cancer treatment often requires chemotherapy, which can be administered through portable devices called elastomeric pumps. These pumps allow medications such as 5-fluorouracil (5-FU) to be delivered continuously over an extended period while patients remain at home rather than staying in the hospital. Although this treatment approach offers greater convenience and independence, patients may experience anxiety and uncertainty related to pump use, treatment side effects, and self-care responsibilities.
This study aims to determine whether providing structured education about elastomeric pump use and 5-FU treatment can improve patients' comfort and reduce anxiety. Participants receiving 5-FU chemotherapy through an elastomeric pump will be assigned to either an education group or a standard care group.
Patients in the education group will receive additional training from the researcher using educational materials and a patient information booklet. The training will include information about safe pump use, management of treatment-related symptoms, precautions to take during treatment, and what to do if problems occur. Patients in the standard care group will continue to receive the routine information and care normally provided by the oncology clinic.
Participants will complete questionnaires that measure comfort and anxiety before the study begins and again one month later. The results will help determine whether structured patient education improves the experience of individuals receiving outpatient chemotherapy through elastomeric pumps.
The findings may help healthcare professionals develop more effective educational programs and supportive care strategies for patients receiving home-based chemotherapy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Biruni University, Istanbul, Zeytinburnu, Turkey (Türkiye)
This randomized controlled trial aims to evaluate the effect of a structured educational intervention on comfort and anxiety levels among cancer patients receiving 5-fluorouracil (5-FU) chemotherapy through elastomeric pumps in an outpatient setting.
The increasing use of elastomeric pumps has enabled the administration of continuous chemotherapy infusions at home, reducing hospitalization and improving treatment convenience. However, patients may experience anxiety and reduced comfort due to insufficient knowledge regarding pump management, treatment-related side effects, and self-care requirements. Providing standardized education may improve patients' understanding of treatment, enhance self-management, and promote psychological well-being.
Eligible participants receiving 5-FU chemotherapy via elastomeric pump will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a structured education program delivered by the researcher using evidence-based educational materials and a patient information booklet specifically prepared for elastomeric pump management. The educational content will include information on pump use, safety precautions, potential complications, symptom management, and appropriate actions in case of treatment-related problems. Participants in the control group will continue to receive routine care and standard education provided by the outpatient oncology clinic.
Data will be collected at baseline and one month after the intervention. Comfort and anxiety levels will be evaluated using validated measurement tools. Changes in outcomes over time and differences between groups will be examined to determine the effectiveness of the educational intervention.
The findings of this study are expected to contribute to oncology nursing practice by providing evidence regarding the role of patient education in improving comfort and reducing anxiety among patients receiving outpatient chemotherapy through elastomeric pumps.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention involves a 15-20 minute face-to-face training session about the use of the elastomeric pump with 5-FU, supported by visual materials and an educational booklet developed by the researchers based on current literature and expert opinion
Time frame: 1 month
Change in anxiety level from baseline to one month post-intervention, measured using the Beck Anxiety Inventory. The Beck Anxiety Inventory is a 21-item self-report scale with scores ranging from 0 to 63. Higher scores indicate greater anxiety severity and therefore a worse outcome. Scores of 0-7 indicate minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26-63 severe anxiety.
Time frame: 1 month
Change in comfort levels from baseline to one month post-intervention, measured using the General Comfort Questionnaire-Short Form, a 28-item, six-point Likert-type scale with a total score ranging from 28 to 168. Higher scores indicate greater comfort, while lower scores indicate less comfort.
Biruni University
Other
The Effect of Education on Comfort and Anxiety Levels in Patients Receiving 5-FU Treatment Administered With an Elastomeric Pump: A Randomized Controlled Trial
Acronym: EDUCAP-5FU
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