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

Primary Purpose

Pneumonia, Bacterial, Cancer, Pneumococcal Infections

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vaccine education
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University Faculty of Medicine Department of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Vaccine education

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 14, 2022
Last Updated
January 27, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05229081
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial, Cancer, Pneumococcal Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine education
Arm Type
Other
Arm Description
The intervention arm refers to the arm in which the pharmacist gives vaccination education.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The control arm refers to the arm that includes patients who receive routine health care services without vaccination education provided by the pharmacist.
Intervention Type
Behavioral
Intervention Name(s)
vaccine education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccination attitude
Description
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.)
Time Frame
3 months after education provision
Title
Knowledge about pneumonia and the pneumococcal vaccine
Description
changes in the patients' Vaccination Knowledge Questionnaire (VKQ) (that consists of 13 questions to be answered as 'yes/no/unknown')
Time Frame
3 months after education provision
Title
Vaccination behavior
Description
changes in the patients' vaccination rates (The vaccination status of patients with the pneumococcal vaccine will be asked.)
Time Frame
3 months after education provision
Secondary Outcome Measure Information:
Title
the relationship between demographic characteristics and pneumococcal vaccination behavior
Description
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.
Time Frame
3 months after education provision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aygin Bayraktar-Ekincioglu
Organizational Affiliation
Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy/Ankara/Turkey
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University Faculty of Medicine Department of Medical Oncology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol and results
IPD Sharing Time Frame
Starting in January 2023
Citations:
PubMed Identifier
20429967
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.
Results Reference
background
PubMed Identifier
31852152
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.
Results Reference
background
PubMed Identifier
23818370
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.
Results Reference
background
PubMed Identifier
28852915
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.
Results Reference
background
PubMed Identifier
23830534
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.
Results Reference
background
Links:
URL
http://www.who.int/topics/immunization/en/
Description
Immunization

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

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