Clinical trial NCT06771999: Attitudes Towards Deprescribing Medications in Cancer Patients and Impact of Educational Intervention by a Clinical Pharmacist
Official title: Attitudes Towards Deprescribing of Non-oncologic Medication in Cancer Pacient and the Impact of an Educational Intervention by a Clinical Pharmacist
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Patients in Palliative Care with Chronic Use of Non-oncologic Medications
Keywords: palliative care
cancer
clinical pharmacist
educational intervention
rPATD
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief summary: Your participation in this study consists in responding to some questions from two questionnaires in Romanian about how you feel about deprescribing, your treatment and how you understand medical information. After that, you'll receive a brochure and watch a video with some basic information about medications and your involvement in treatment decisions and in the next visit for your cancer treatment you 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, we will investigate health care literacy using a validated questionnaire in Romanian (HLS-EU-Q16). In this study we will also investigate 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.

Eligibility criteria: Inclusion Criteria:

* cancer patients in palliative treatment
* ECOG 1-2

Exclusion Criteria:

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

Primary outcomes:
measure: Impact of educational intervention performed by clinical pharmacist
timeFrame: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days)
Secondary outcomes:
measure: Attitudes towards deprescribing medications in cancer patients in palliative treatment
timeFrame: from enrollment to the next cycle of oncological treatment (14, 21 or 28 days days) when they answer the second time
measure: The level of health literacy
timeFrame: at enrollment
Other outcomes:
measure: Demographic characteristics of the population included in this study
timeFrame: at enrollment
Locations:
city: Baia Mare
country: Romania
facility: Constantin Opris Emergency County Hospital
state: Maramures
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.