NCT06771999

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2025Apr 2027

First Submitted

Initial submission to the registry

January 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

January 7, 2025

Last Update Submit

February 11, 2026

Conditions

CancerPalliative Care

Keywords

palliative carecancerclinical pharmacisteducational interventionrPATD

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Attitudes towards deprescribing medications in cancer patients in palliative treatment

    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

    at enrollment

Other Outcomes (1)

  • Demographic characteristics of the population included in this study

    at enrollment

Study Arms (1)

Educational intervention by a clinical pharmacist

EXPERIMENTAL

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

Other: Educational intervention by a clinical pharmacist

Interventions

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.

Educational intervention by a clinical pharmacist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cancer patients in palliative treatment
  • ECOG 1-2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Constantin Opris Emergency County Hospital

Baia Mare, Maramureş, 430031, Romania

RECRUITING

Related Publications (5)

  • 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: 27785734BACKGROUND

  • 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: 31430394BACKGROUND

  • 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: 35185446BACKGROUND

  • 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: 37495451BACKGROUND

  • 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: 29869294BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mihaela I Clinical pharmacist, PhD student

CONTACT

0741167906miha.onea@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 13, 2025

Study Start

January 13, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

RO(1)