- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771999
Attitudes Towards Deprescribing Medications in Cancer Patients and Impact of Educational Intervention by a Clinical Pharmacist
Attitudes Towards Deprescribing of Non-oncologic Medication in Cancer Pacient and the Impact of an Educational Intervention by a Clinical Pharmacist
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mihaela I Clinical Pharmacist, PhD student
- Phone Number: +4 0741167906
- Email: miha.onea@yahoo.com
Study Locations
-
-
Maramureş
-
Baia Mare, Maramureş, Romania, 430031
- Recruiting
- Constantin Opris Emergency County Hospital
-
Contact:
- Mihaela I Clinical Pharmacist, PhD student
- Phone Number: +4 0741167906
- Email: miha.onea@yahoo.com
-
Contact:
- Mihaela PhD student, clinical pharmacist, pharmacist
- Phone Number: +40741167906
- Email: miha.onea@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- cancer patients in palliative treatment
- ECOG 1-2
Exclusion Criteria:
- cancer patients in curative treatment
- ECOG 3-4
- cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 |
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
|
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
|
at enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic characteristics of the population included in this study
Time Frame: at enrollment
|
Investigators will be able to characterize a population of cancer patients in Romania: number of medications, number of diseases, social background (still working or retiered) , literacy (under 8 classes, 8 classes, highschool, vocational school, superior degree).
|
at enrollment
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 198/11OCT2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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