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

NCT ID: NCT06771999

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2026-04-30

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.

Conditions

Cancer Patients in Palliative Care with Chronic Use of Non-oncologic Medications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Educational intervention by a clinical pharmacist

educational 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

Group Type: EXPERIMENTAL

Educational intervention by a clinical pharmacist

Intervention Type: OTHER

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.

Interventions

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 in treatment decision. When participants come to another cancer treatment (after 14 , 21 or 28 days), the rPATD will be completed again.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• cancer patients in palliative treatment
• ECOG 1-2

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Mihaela Onea

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Constantin Opris Emergency County Hospital

Baia Mare, Maramureş, Romania

Countries

Romania

Central Contacts

Mihaela I Clinical pharmacist, PhD student

Role: CONTACT

miha.onea@yahoo.com

0741167906 ext. +4

Facility Contacts

Mihaela I Clinical Pharmacist, PhD student

Role: primary

miha.onea@yahoo.com

0741167906 ext. +4

References

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.

Reference Type: BACKGROUND

PMID: 27785734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31430394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35185446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37495451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29869294 (View on PubMed)

Other Identifiers

198/11OCT2024

Identifier Type: -

Identifier Source: org_study_id