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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational intervention by a clinical pharmacist | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes towards deprescribing medications in cancer patients in palliative treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics of the population included in this study | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihaela I Clinical pharmacist, PhD student | Contact | 0741167906 | +4 | miha.onea@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Constantin Opris Emergency County Hospital | Recruiting | Baia Mare | Maramureş | 430031 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27785734 | Background | 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. | |
| 31430394 | Background | 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. |
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PhD contract might affect sharing the IPD until PhD defense
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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.
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| 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 | 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 |
| 35185446 | Background | 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. |
| 37495451 | Background | 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. |
| 29869294 | Background | 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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