DESIGN OF A SCALE TO MEASURE COMPLIANCE WITH DRUG TREATMENT IN PATIENTS WITH ORAL CHEMOTHERAPY

NCT ID: NCT04550533

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-12-31

Brief Summary

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Introduction: In recent years, there has been an increase in the use of oral chemotherapy, for its comfort and for allowing a higher quality of life. However, one of the main drawbacks is the lack of adherence to treatment with important clinical, social and economic consequences. In this scenario, the investigators did not have a questionnaire designed and validated to measure adherence in onco-hematological patients, a population that was erroneously considered very adherent.

The objective of the investigators is to build and validate a questionnaire to measure adherence to treatment in oncohematological patients in treatment with oral anti-cancer drugs.

Methods and analysis: An observational study to validate questionnaires will be carried out combining qualitative and quantitative research techniques. With the results of a systematic review of the literature and a qualitative study based on focus groups, a questionnaire will be designed to measure adherence in oncohematological patients in treatment with with oral anti-cancer drugs. The investigators will include patiens from two hospitals in the Valencian Community.

Discussion: It is essential to have a simple, reliable and validated instrument for measuring adherence in cancer patients undergoing treatment with oral antineoplastic agents. With this, lack of therapeutic compliance and its causes can be detected in order to establish interventions that improve it.

Detailed Description

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Conditions

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Adherence, Medication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Therapeutic Adherence

To measure adherence to treatment in oncohematological patients in treatment with oral anti-cancer drugs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 18 in treatment with oral anti-cancer drugs (groups L01 and L02 according to the ATC drug classification), that come to the San Juan Hospital or Elda General Hospital to collect their medication, will be included.

Exclusion Criteria

* Those patients with communication difficulties, and/or do not agree to take part in the study, will be excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Elsa López Pintor

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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18/327

Identifier Type: -

Identifier Source: org_study_id

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