AnxietyEDUCAP-5FUNCT07061236
Education Effect on Comfort and Anxiety in 5-FU Elastomeric Pump Therapy
A study testing Elastomeric Pump Education in people with Anxiety and Cancer, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Cancer, Chemotherapy
- What is being tested?
- Elastomeric Pump Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Jul 2025to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with a psychiatric disorder,
- Unable to communicate effectively,
- Refusing to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Biruni University
Istanbul, Zeytinburnu, 34015
Koç University Hospital
Istanbul
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anxiety, Cancer, Chemotherapy, Nurses, Port Catheters
- Being tested
- Elastomeric Pump Education
- Keywords
- Anxiety, Cancer, Chemotherapy, Nurses, Port Catheters
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastomeric Pump EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 5-FU Elastomeric Pump Education Program | Experimental | Patients will receive face-to-face training on the use of the elastomeric pump with 5-FU, supported by an educational booklet. Receives: Other: Elastomeric Pump Education |
| Standard Oncology Education and Care | No intervention | Patients will receive standard institutional care without any additional education or training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (Beck Anxiety Inventory Score)
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.
Measured: 1 month
Secondary outcomes (1)
Comfort (General Comfort Questionnaire-Short Form Score)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start8 Jul 2025
- Primary completion11 Aug 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to intervention or control group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Karaca, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061236
- Sponsor's protocol ID
- AKaraca
- Other IDs
- AKaraca
- Acronym
- EDUCAP-5FU
- Status last verified
- Nov 2025
- First submitted
- 2 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared upon reasonable request and subject to approval by the ethics committee.
Publications
Yilmaz SG, Arslan S. Effects of progressive relaxation exercises on anxiety and comfort of Turkish breast cancer patients receiving chemotherapy. Asian Pac J Cancer Prev. 2015;16(1):217-20. doi: 10.7314/apjcp.2015.16.1.217.
PubMed 25640354Uslu, Y., Olgun, N., Karanlık, H., User, İ. (2019). Port kateter uygulamaları: kanserli hastaların deneyimlerine ilişkin niteliksel bir çalışma. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, 10(3), 464-472.
Ulusoy, M., Şahin, N., Erkmen, H. (1998). Turkish version of The Beck Anxiety Inventory: Psychometric properties. Journal of Cognitive Psychother, 12, 28-35.
Temiz G, Durna Z. Evaluation of Quality of Life and Health Care Needs in Cancer Patients Receiving Chemotherapy. J Cancer Educ. 2020 Aug;35(4):796-807. doi: 10.1007/s13187-019-01533-2.
PubMed 31054110Shoemaker LK, Arora U, Rocha Lima CM. 5-fluorouracil-induced coronary vasospasm. Cancer Control. 2004 Jan-Feb;11(1):46-9. doi: 10.1177/107327480401100207.
PubMed 14749623Stewart T, Pavlakis N, Ward M. Cardiotoxicity with 5-fluorouracil and capecitabine: more than just vasospastic angina. Intern Med J. 2010 Apr;40(4):303-7. doi: 10.1111/j.1445-5994.2009.02144.x.
PubMed 20529041Sayin Y, Aksoy G. The effect of analgesic education on pain in patients undergoing breast surgery: within 24 hours after the operation. J Clin Nurs. 2012 May;21(9-10):1244-53. doi: 10.1111/j.1365-2702.2011.04009.x. Epub 2012 Mar 8.
PubMed 22404338Pu YL, Li ZS, Zhi XX, Shi YA, Meng AF, Cheng F, Ali A, Li C, Fang H, Wang C. Complications and Costs of Peripherally Inserted Central Venous Catheters Compared With Implantable Port Catheters for Cancer Patients: A Meta-analysis. Cancer Nurs. 2020 Nov/Dec;43(6):455-467. doi: 10.1097/NCC.0000000000000742.
PubMed 31464692Pinelli F, Cecero E, Degl'Innocenti D, Selmi V, Giua R, Villa G, Chelazzi C, Romagnoli S, Pittiruti M. Infection of totally implantable venous access devices: A review of the literature. J Vasc Access. 2018 May;19(3):230-242. doi: 10.1177/1129729818758999. Epub 2018 Mar 7.
PubMed 29512430Paleczny J, Banys-Jafernik B, Gazurek K, Kierpiec K, Szczerba H, Zipser P. Long-term totally implantable venous access port systems--one center experience. Anaesthesiol Intensive Ther. 2013 Oct-Dec;45(4):215-22. doi: 10.5603/AIT.2013.0042.
PubMed 24407899Paiva BS, de Carvalho AL, Kolcaba K, Paiva CE. Validation of the Holistic Comfort Questionnaire-caregiver in Portuguese-Brazil in a cohort of informal caregivers of palliative care cancer patients. Support Care Cancer. 2015 Feb;23(2):343-51. doi: 10.1007/s00520-014-2370-5. Epub 2014 Aug 2.
PubMed 25082367Öztaş, M., Alkan, İ., Öztaş, B. (2022). Determination of nursing practices regarding port catheter care. J Med Palliat Care, 3(1), 33-38.
Ozden D, Caliskan N. Turkish nurses' level of knowledge regarding implantable port catheter care. Jpn J Nurs Sci. 2012 Jun;9(1):1-8. doi: 10.1111/j.1742-7924.2011.00177.x. Epub 2011 Mar 14.
PubMed 22583935Önder, H., Tekbaş, G., Turmak, M., İnal, A., Ekici, F., Gümüş, H, Önder, A. (2014). Image-guided subcutaneous port implantation in patients with malignant diseases. European Journal of General Medicine, 1, 1-6.
Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.
PubMed 23978939
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education on Comfort and Anxiety Levels in Patients Receiving 5-FU Treatment Administered With an Elastomeric Pump: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07061236
- Acronym / sponsor ID
- EDUCAP-5FU / AKaraca
- Conditions
- Anxiety, Cancer, Chemotherapy, Nurses, Port Catheters
- Keywords
- Anxiety, Cancer, Chemotherapy, Nurses, Port Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to intervention or control group
| Arm | Type | Receives |
|---|---|---|
| 5-FU Elastomeric Pump Education Program | Experimental | Other: Elastomeric Pump EducationPatients will receive face-to-face training on the use of the elastomeric pump with 5-FU, supported by an educational booklet. |
| Standard Oncology Education and Care | No intervention | –Patients will receive standard institutional care without any additional education or training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with a psychiatric disorder,
- Unable to communicate effectively,
- Refusing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastomeric Pump EducationThis 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 | Other | 5-FU Elastomeric Pump Education Program |
Primary outcome
Anxiety (Beck Anxiety Inventory Score)
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.
1 secondary outcome
Comfort (General Comfort Questionnaire-Short Form Score)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 25640354Yilmaz SG, Arslan S. Effects of progressive relaxation exercises on anxiety and comfort of Turkish breast cancer patients receiving chemotherapy. Asian Pac J Cancer Prev. 2015;16(1):217-20. doi: 10.7314/apjcp.2015.16.1.217.
- Results publicationUslu, Y., Olgun, N., Karanlık, H., User, İ. (2019). Port kateter uygulamaları: kanserli hastaların deneyimlerine ilişkin niteliksel bir çalışma. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, 10(3), 464-472.
- Results publicationUlusoy, M., Şahin, N., Erkmen, H. (1998). Turkish version of The Beck Anxiety Inventory: Psychometric properties. Journal of Cognitive Psychother, 12, 28-35.
- Results publication: PubMed 31054110Temiz G, Durna Z. Evaluation of Quality of Life and Health Care Needs in Cancer Patients Receiving Chemotherapy. J Cancer Educ. 2020 Aug;35(4):796-807. doi: 10.1007/s13187-019-01533-2.
- Results publication: PubMed 14749623Shoemaker LK, Arora U, Rocha Lima CM. 5-fluorouracil-induced coronary vasospasm. Cancer Control. 2004 Jan-Feb;11(1):46-9. doi: 10.1177/107327480401100207.
- Results publication: PubMed 20529041Stewart T, Pavlakis N, Ward M. Cardiotoxicity with 5-fluorouracil and capecitabine: more than just vasospastic angina. Intern Med J. 2010 Apr;40(4):303-7. doi: 10.1111/j.1445-5994.2009.02144.x.
- Results publication: PubMed 22404338Sayin Y, Aksoy G. The effect of analgesic education on pain in patients undergoing breast surgery: within 24 hours after the operation. J Clin Nurs. 2012 May;21(9-10):1244-53. doi: 10.1111/j.1365-2702.2011.04009.x. Epub 2012 Mar 8.
- Results publication: PubMed 31464692Pu YL, Li ZS, Zhi XX, Shi YA, Meng AF, Cheng F, Ali A, Li C, Fang H, Wang C. Complications and Costs of Peripherally Inserted Central Venous Catheters Compared With Implantable Port Catheters for Cancer Patients: A Meta-analysis. Cancer Nurs. 2020 Nov/Dec;43(6):455-467. doi: 10.1097/NCC.0000000000000742.
- Results publication: PubMed 29512430Pinelli F, Cecero E, Degl'Innocenti D, Selmi V, Giua R, Villa G, Chelazzi C, Romagnoli S, Pittiruti M. Infection of totally implantable venous access devices: A review of the literature. J Vasc Access. 2018 May;19(3):230-242. doi: 10.1177/1129729818758999. Epub 2018 Mar 7.
- Results publication: PubMed 24407899Paleczny J, Banys-Jafernik B, Gazurek K, Kierpiec K, Szczerba H, Zipser P. Long-term totally implantable venous access port systems--one center experience. Anaesthesiol Intensive Ther. 2013 Oct-Dec;45(4):215-22. doi: 10.5603/AIT.2013.0042.
- Results publication: PubMed 25082367Paiva BS, de Carvalho AL, Kolcaba K, Paiva CE. Validation of the Holistic Comfort Questionnaire-caregiver in Portuguese-Brazil in a cohort of informal caregivers of palliative care cancer patients. Support Care Cancer. 2015 Feb;23(2):343-51. doi: 10.1007/s00520-014-2370-5. Epub 2014 Aug 2.
- Results publicationÖztaş, M., Alkan, İ., Öztaş, B. (2022). Determination of nursing practices regarding port catheter care. J Med Palliat Care, 3(1), 33-38.
- Individual participant dataSharing planned: No. Data will only be shared upon reasonable request and subject to approval by the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastomeric Pump Education in people with Anxiety and Cancer, run by Biruni University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (Beck Anxiety Inventory Score) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07061236, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.