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Recruiting NCT06771999

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

No phase Interventional Palliative Care Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational intervention by a clinical pharmacist.
Who it may be relevant to
Registry conditions: Palliative Care, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Educational intervention by a clinical pharmacist
    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

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • Attitudes towards deprescribing medications in cancer patients in palliative treatment [Time frame: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days) when they answer the second time]
  • The level of health literacy [Time frame: at enrollment]

Eligibility criteria

Inclusion criteria

  • cancer patients in palliative treatment
  • ECOG 1-2

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Romania · 1 center
  • Constantin Opris Emergency County Hospital — Baia Mare

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29869294

Identifiers

NCT: NCT06771999 · 198/11OCT2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗