NCT07061236 — Education Effect on Comfort and Anxiety in 5-FU Elastomeric Pump Therapy · CancerIndex
Clinical trial · Interventional
Education Effect on Comfort and Anxiety in 5-FU Elastomeric Pump Therapy
The Effect of Education on Comfort and Anxiety Levels in Patients Receiving 5-FU Treatment Administered With an Elastomeric Pump: A Randomized Controlled Trial
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Patients will receive face-to-face training on the use of the elastomeric pump with 5-FU, supported by an educational booklet.
interventionNames
Other: Elastomeric Pump Education
type
NO_INTERVENTION
label
Standard Oncology Education and Care
description
Patients will receive standard institutional care without any additional education or training.
Primary outcomes (1)
measure
Anxiety (Beck Anxiety Inventory Score)
timeFrame
1 month
description
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.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosed with cancer,
* Able to understand Turkish and literate,
* Medically fit to participate in the study,
* Willing to participate in the study,
* Aged 18 years or older.
Exclusion Criteria:
* Diagnosed with a psychiatric disorder,
* Unable to communicate effectively,
* Refusing to participate in the study.
References
Publications (29)
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Secondary outcomes (1)
measure
Comfort (General Comfort Questionnaire-Short Form Score)
timeFrame
1 month
description
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.
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