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

October 2, 2020 updated by: Elsa López Pintor, Universidad Miguel Hernandez de Elche

DESIGN AND VALIDATION OF A SCALE TO EVALUATE THERAPEUTIC ADHERENCE IN PATIENTS WITH ANTINEOPLASTIC DRUGS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over the age of 18 in treatment with oral anti-cancer drugs (groups L01 and L02 according to the ATC drug classification) who come to hospital to collect their medication,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of therapeutic adherence
Time Frame: At least 3 month after treatment
To build and validate a questionnaire to measure adherence to treatment in oncohematological patients in treatment with oral antineoplastic drugs
At least 3 month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers and difficulties in evaluating adherence
Time Frame: At least 3 month after treatment
To understand the barriers and difficulties in evaluating adherence to treatment with oral antineoplastic drug in oncohematological patients through a bibliographic search and by carrying out discussion groups with professionals and patients.
At least 3 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 18/327

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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