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

NCT05229081 | Completed

• 1 other identifier: Oz2214836
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Bacterial; Cancer; Pneumococcal Infections

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• the relationship between demographic characteristics and pneumococcal vaccination behavior

  3 months after education provision

Study Arms (2)

Vaccine education

OTHER

The intervention arm refers to the arm in which the pharmacist gives vaccination education.

Behavioral: vaccine education

Standard of Care

NO INTERVENTION

The control arm refers to the arm that includes patients who receive routine health care services without vaccination education provided by the pharmacist.

Interventions

vaccine education BEHAVIORAL

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.

Vaccine education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Medicine Department of Medical Oncology

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 20429967 BACKGROUND

• 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.

  PMID: 31852152 BACKGROUND

• 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.

  PMID: 23818370 BACKGROUND

• 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.

  PMID: 28852915 BACKGROUND

• 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.

  PMID: 23830534 BACKGROUND

Related Links

• Immunization

MeSH Terms

Conditions

Pneumonia, Bacterial; Neoplasms; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections

Study Officials

• Aygin Bayraktar-Ekincioglu

  Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy/Ankara/Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 8, 2022
• Study Start: July 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 15, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Starting in January 2023

Locations

TU (1)