Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients

Cancer Clinical Trial

Official title:

Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229081
• Other study ID #: Oz2214836
• Status: Completed
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: January 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the World Health Organization (WHO), immunization; is defined as making a person immune or resistant to an infectious disease by applying a vaccine (1). The primary indicator of an effective immunization is that adequate vaccination rates have been achieved. The risk of cancer and chronic diseases increases with advancing age, which increases the importance of immunization in adults. Cancer patients, one of the patient groups for whom adult immunization is a priority and crucial, are subjected to immunosuppressive medications, making them vulnerable to infections. In cancer patients, infections are severe, antimicrobial treatments are sometimes insufficient, leading to morbidity and mortality. One of these infections is pneumococcal disease caused by Streptococcus pneumonia, with high morbidity and mortality in cancer patients. Invasive pneumococcal disease is seen 23-48 times more frequently in cancer patients compared to healthy individuals. In many countries worldwide, the 13-valent pneumococcal conjugate vaccine and the 23-valent polysaccharide pneumococcal vaccine, both developed to prevent pneumonia caused by Streptococcus pneumonia, are successfully used in childhood vaccination programs within the framework of WHO's immunization policies. However, in Turkey, like in the rest of the world, the required adult immunization rates have not been achieved yet. Immunization rates among cancer patients, one of the patient groups for whom adult vaccination is required, remain below the targeted levels. Pharmacists, one of the health professionals, have significant contributions to increasing vaccination rates in adults. According to studies, pharmacists can help raise immunization rates by providing education and information. In Turkey, no study has been conducted to assess the impact of vaccination education on cancer patients' attitudes and actions about the pneumococcal vaccine. This study aimed to determine the impact of pharmacist-led pneumonia and pneumococcal vaccine education on cancer patients' vaccination attitudes, knowledge, and vaccination rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:The study will involve patients who have all of the following features simultaneously.

• patients who visit medical oncology outpatient clinics,
• patients who are over 18 years old,
• patients who have been diagnosed with cancer for less than two years,
• patients who are in remission stage (as determined by a medical oncologist),
• patients who have never had the pneumococcal vaccine.

Exclusion Criteria:

• patients who could not communicate in Turkish,
• patients who were illiterate,
• patients who had visual/auditory/cognitive impairments,
• patients who had previously received a pneumococcal vaccine recommendation,
• patients who did not know their pneumococcal immunization status
• patients who want to leave the study

Related Conditions & MeSH terms

• Cancer
• Pneumococcal Infections
• Pneumonia, Bacterial

Intervention

Behavioral:
• vaccine education
The educational content was developed based on research and expert perspectives and included general information about immunization, pneumonia, and pneumococcal vaccines, as well as vaccine myths. This information was first conveyed to the patients verbally, and then booklets with the same material were handed to them. The Pneumococcal Conjugate Vaccine 13 (PCV13) vaccination was recommended based on Infectious Disease Society of America (IDSA), Advisory Committee on Immunization Practices (ACIP), and national adult immunization guidelines.

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Medicine Department of Medical Oncology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Chiou WY, Hung SK, Lin HY, Chen LC, Hsu FC, Tsai SJ, Yu BH, Lee MS, Li CY. Effectiveness of 23-valent pneumococcal polysaccharide vaccine on elderly patients with colorectal cancer: A population-based propensity score-matched cohort study. Medicine (Baltimore). 2019 Dec;98(50):e18380. doi: 10.1097/MD.0000000000018380. — View Citation

Klassing HM, Ruisinger JF, Prohaska ES, Melton BL. Evaluation of Pharmacist-Initiated Interventions on Vaccination Rates in Patients with Asthma or COPD. J Community Health. 2018 Apr;43(2):297-303. doi: 10.1007/s10900-017-0421-9. — View Citation

Otsuka SH, Tayal NH, Porter K, Embi PJ, Beatty SJ. Improving herpes zoster vaccination rates through use of a clinical pharmacist and a personal health record. Am J Med. 2013 Sep;126(9):832.e1-6. doi: 10.1016/j.amjmed.2013.02.018. Epub 2013 Jul 3. — View Citation

Urun Y, Akbulut H, Demirkazik A, Cay Senler F, Utkan G, Onur H, Icli F. Perception about influenza and pneumococcal vaccines and vaccination coverage among patients with malignancies and their family members. J BUON. 2013 Apr-Jun;18(2):511-5. — View Citation

Wong A, Marrie TJ, Garg S, Kellner JD, Tyrrell GJ; SPAT Group. Increased risk of invasive pneumococcal disease in haematological and solid-organ malignancies. Epidemiol Infect. 2010 Dec;138(12):1804-10. doi: 10.1017/S0950268810000919. Epub 2010 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination attitude	changes in the patients' Vaccination Attitudes Examination (VAX )Scale scores (This scale consists of 12 items and four subgroups (mistrust of vaccine benefit, worries about unforeseen future effects, concerns about commercial profiteering, and preference for natural immunity) to be responded on a 6-point Likert scale, and the total score ranges between 12-72. The higher scores indicate the anti-vaccination attitudes of the patients.)	3 months after education provision
Primary	Knowledge about pneumonia and the pneumococcal vaccine	changes in the patients' Vaccination Knowledge Questionnaire (VKQ) (that consists of 13 questions to be answered as 'yes/no/unknown')	3 months after education provision
Primary	Vaccination behavior	changes in the patients' vaccination rates (The vaccination status of patients with the pneumococcal vaccine will be asked.)	3 months after education provision
Secondary	the relationship between demographic characteristics and pneumococcal vaccination behavior	determining factors affecting pneumococcal vaccination behavior in patients. Parameters (age, gender, educational status, etc.) that differ statistically between vaccinated and unvaccinated patients will be determined, and then logistic regression will be made for these parameters to determine the factors affecting vaccinating behavior.	3 months after education provision

External Links

•   Immunization