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

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05229081
Collaborator
(none)
228
1
2
19
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: vaccine education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled StudyRandomized Controlled Study
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients: A Randomized Controlled Study
Actual Study Start Date :
Jul 19, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Feb 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Vaccine education

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

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.

No Intervention: Standard of Care

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

Outcome Measures

Primary Outcome Measures

  1. Vaccination attitude [3 months after education provision]

    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.)

  2. Knowledge about pneumonia and the pneumococcal vaccine [3 months after education provision]

    changes in the patients' Vaccination Knowledge Questionnaire (VKQ) (that consists of 13 questions to be answered as 'yes/no/unknown')

  3. Vaccination behavior [3 months after education provision]

    changes in the patients' vaccination rates (The vaccination status of patients with the pneumococcal vaccine will be asked.)

Secondary Outcome Measures

  1. the relationship between demographic characteristics and pneumococcal vaccination behavior [3 months after education provision]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Faculty of Medicine Department of Medical Oncology Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Study Chair: Aygin Bayraktar-Ekincioglu, Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy/Ankara/Turkey

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Nesligul Ozdemir, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05229081
Other Study ID Numbers:
  • Oz2214836
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022