AzTrials
AzTrials

Palliative CareNCT06771999

Attitudes Towards Deprescribing Medications in Cancer Patients and Impact of Educational Intervention by a Clinical Pharmacist

A study testing Educational intervention by a clinical pharmacist in people with Palliative Care and Cancer, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Participation in this study consists in responding to some questions from two questionnaires in Romanian about how participants feel about deprescribing, participants' treatment and how participants understand medical information. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care, Cancer
What is being tested?
Educational intervention by a clinical pharmacist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteRomania
Study dates
13 Jan 2025to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • cancer patients in palliative treatment
  • ECOG 1-2

Who cannot join

  • cancer patients in curative treatment
  • ECOG 3-4
  • cognitive impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mihaela I Clinical pharmacist, PhD student contact

0741167906 ext. +4

miha.onea@yahoo.com

Romania1 site, 1 recruiting

  • Constantin Opris Emergency County Hospital

    Baia Mare, Maramureş, 430031

    Mihaela I Clinical Pharmacist, PhD student, 0741167906 ext. +4, miha.onea@yahoo.com

    Mihaela PhD student, clinical pharmacist, pharmacist, +40741167906, miha.onea@yahoo.com

    Recruiting

Other trials in Romania

About this study

Official title: Attitudes Towards Deprescribing of Non-oncologic Medication in Cancer Pacient and the Impact of an Educational Intervention by a Clinical Pharmacist

Participation in this study consists in responding to some questions from two questionnaires in Romanian about how participants feel about deprescribing, participants' treatment and how participants understand medical information. After that, participants will receive a brochure and watch a video with some basic information about medications and participants' involvement in treatment decisions and in the next visit for cancer treatment participants will be asked to answer questions from one of the initial questionnaire.

Read the detailed description

Cancer patients are susceptible to using a lot of medications, with an increased risk of drug-related problems that could lead to adverse reactions from oncological drugs, hospital admissions, deteriorated performance status and increased mortality. In time, some medications may no longer be efficient, may have adverse reactions or may lose their indication and need to be stopped or replaced. This process is named deprescribing and it's supervised by a health care professional. Deprescribing can't be done without the implication of the patients, that's why it's important to investigate cancer patient's attitudes towards deprescribing non-oncologic medications in Romanian patients using a validated questionnaire (rPATD). Recent studies from Romania showed a possible lack of health care literacy that could affect patients involvement in treatment decision. In this study, will investigate health care literacy using a validated questionnaire in Romanian (HLS-EU-Q16). In this study investigators will also study if an educational intervention (targeting patients involvement in treatment decision and mandatory, minimal information about efficacy of a treatment and its adverse reactions) conducted by a clinical pharmacist using a brochure and a video will improve their engagement and knowledge about drugs. Impact of educational intervention will be investigated by applying the rPATD questionnaire before and after the intervention.

Being tested
Educational intervention by a clinical pharmacist
Keywords
palliative care, cancer, clinical pharmacist, educational intervention, rPATD
Medical subject headings
Neoplasms

What participants receive

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

  • Educational intervention by a clinical pharmacistOther

    All participants will respond to two questionnaires, both validated in Romanian and some demographic information. One is the rPATD questionnaire that investigate attitudes towards deprescribing of medication and the other one is the HLS-EU-Q16 that investigates medical literacy of participants. After completion, the clinical pharmacist will give a brochure and a video about the process of deprescribing, information about the efficacy and the adverse reactions of medicines and the role of pacient in treatment decision. When participants come to another cancer treatment (after 14 , 21 or 28 days), the rPATD will be completed again.

Study groups in NCT06771999
Study groupRoleWhat they receive
Educational intervention by a clinical pharmacistExperimentaleducational intervention using a brochure and a video with information about deprescribing, effectiveness and adverse reactions of medicines and the role of patient in treatment decision
Receives: Other: Educational intervention by a clinical pharmacist

What is being measured

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

  1. Impact of educational intervention performed by clinical pharmacist

    Participants will be asked to complete the same questionnaire before and after an educational intervention in order to assess if this kind of educational intervention is suitable for Romanian participants. Based on answers given to the same questions before and after the intervention, investigators can see if and what is changed in the perception of participants.

    Measured: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days)

Secondary outcomes (2)

  1. Attitudes towards deprescribing medications in cancer patients in palliative treatment

    Using the rPATD questionnaire (revised Patients Attitudes Towards Deprescribing ), investigators assess if Romanian cancer patients are willing to have their medication deprescribed. The questionnaire has 4 factors:

    Burden, Appropriateness, Involvement and Concerns about Stopping. Each factor consists of 5 statements and participants are invited to respond to a 5-point Likert scale (strongly agree =5, agree =4, unsure =3, disagree =2, strongly disagree =1). Factors' scores are calculated as the average of the summed score for the five statements pertaining to each factor, with a final score per factor ranging from 1 to 5. A higher score indicates a greater perceived burden, higher concerns about stopping and greater involvement in medication related decisions. The appropriateness factor is reversed scored so that a higher score indicates a greater belief in the appropriateness of current medications

    Measured: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days) when they answer the second time

  2. The level of health literacy

    Using the questionnaire HLS-EU-Q16 investigators can asses the level of health literacy of participants. Each of the 16 items are scored on a 4-point Likert scale ranging from 1 ("very difficult") to 4 ("very easy"). For interpretation of the final score, all items of the scale are summed, giving a score ranging between 0 (no health literacy) to 16 (high health literacy). For ease of interpretability, the three levels are identified: inadequate health literacy (0-8), problematic health literacy [9-12], and sufficient health literacy

    Measured: at enrollment

Timeline

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

  1. First posted13 Jan 2025
  2. Study start13 Jan 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will respond to two questionnaires, both validated in Romanian and some demographic information. One is the rPATD questionnaire that investigate attitudes towards deprescribing of medication and the other one is the HLS-EU-Q16 that investigates medical literacy of participants. After completion, the clinical pharmacist will give a brochure and a video about the process of deprescribing, information about the efficacy and the adverse reactions of medicines and the role of pacient in treatment decision. When participants come to another cancer treatment (after 14, 21 or 28 days), the rPATD will be completed again.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771999
Sponsor's protocol ID
198/11OCT2024
Status last verified
Feb 2026
First submitted
7 Jan 2025
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: PhD contract might affect sharing the IPD until PhD defense

Publications

  • Reeve E, Low LF, Shakib S, Hilmer SN. Development and Validation of the Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire: Versions for Older Adults and Caregivers. Drugs Aging. 2016 Dec;33(12):913-928. doi: 10.1007/s40266-016-0410-1.

    PubMed 27785734

  • Linsky A, Gellad WF, Linder JA, Friedberg MW. Advancing the Science of Deprescribing: A Novel Comprehensive Conceptual Framework. J Am Geriatr Soc. 2019 Oct;67(10):2018-2022. doi: 10.1111/jgs.16136. Epub 2019 Aug 20.

    PubMed 31430394

  • Coman MA, Forray AI, Van den Broucke S, Chereches RM. Measuring Health Literacy in Romania: Validation of the HLS-EU-Q16 Survey Questionnaire. Int J Public Health. 2022 Feb 4;67:1604272. doi: 10.3389/ijph.2022.1604272. eCollection 2022.

    PubMed 35185446

  • Bucsa C, Onea M, Rusu A, Farcas A, Porojan M, Dumitrascu D, Iaru I, Leucuta D, Mogosan C, Reeve E, Moga D. Translation, cultural adaptation and validation of the revised patients' attitudes towards deprescribing (rPATD) questionnaire in Romanian older adults. Res Social Adm Pharm. 2023 Nov;19(11):1471-1479. doi: 10.1016/j.sapharm.2023.07.011. Epub 2023 Jul 20.

    PubMed 37495451

  • Whitman A, DeGregory K, Morris A, Mohile S, Ramsdale E. Pharmacist-led medication assessment and deprescribing intervention for older adults with cancer and polypharmacy: a pilot study. Support Care Cancer. 2018 Dec;26(12):4105-4113. doi: 10.1007/s00520-018-4281-3. Epub 2018 Jun 4.

    PubMed 29869294

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention by a clinical pharmacist in people with Palliative Care and Cancer, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 Romania. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Mihaela I Clinical pharmacist, PhD student (0741167906 ext. +4, miha.onea@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of educational intervention performed by clinical pharmacist (time frame: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days)). 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 NCT06771999, 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 13 Feb 2026.

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