Clinical trial NCT05229081: Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients
Official title: Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Bacterial
Cancer
Pneumococcal Infections
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vaccination attitude
timeFrame: 3 months after education provision
measure: Knowledge about pneumonia and the pneumococcal vaccine
timeFrame: 3 months after education provision
measure: Vaccination behavior
timeFrame: 3 months after education provision
Secondary outcomes:
measure: the relationship between demographic characteristics and pneumococcal vaccination behavior
timeFrame: 3 months after education provision
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine Department of Medical Oncology
Study officials:
affiliation: Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy/Ankara/Turkey
name: Aygin Bayraktar-Ekincioglu
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
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.