AzTrials
AzTrials

Pneumonia, BacterialNCT05229081

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

A study testing vaccine education in people with Pneumonia, Bacterial and Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vaccine education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Jul 2019to 15 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University Faculty of Medicine Department of Medical Oncology

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
vaccine education
Medical subject headings
Pneumonia, Bacterial, Neoplasms, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vaccine educationBehavioural

    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.

Study groups in NCT05229081
Study groupRoleWhat they receive
Vaccine educationOtherThe intervention arm refers to the arm in which the pharmacist gives vaccination education.
Receives: Behavioral: vaccine education
Standard of CareNo interventionThe control arm refers to the arm that includes patients who receive routine health care services without vaccination education provided by the pharmacist.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: 3 months after education provision

  2. 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')

    Measured: 3 months after education provision

  3. Vaccination behavior

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

    Measured: 3 months after education provision

Secondary outcomes (1)

  1. 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.

    Measured: 3 months after education provision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start19 Jul 2019
  3. Primary completion31 Dec 2020
  4. Study completion15 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Study
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229081
Sponsor's protocol ID
Oz2214836
Status last verified
Jan 2022
First submitted
14 Jan 2022
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study protocol and results

Publications

  • 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.

    PubMed 20429967

  • 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.

    PubMed 31852152

  • 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.

    PubMed 23818370

  • 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.

    PubMed 28852915

  • 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.

    PubMed 23830534

Questions about this trial

What is this clinical trial studying?

A study testing vaccine education in people with Pneumonia, Bacterial and Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccination attitude (time frame: 3 months after education provision). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229081, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in