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

NCT04550533 | Unknown

• 1 other identifier: 18/327
• Study Type: observational
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• Measure of therapeutic adherence

  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 Outcomes (1)

• Barriers and difficulties in evaluating adherence

  At least 3 month after treatment

Interventions

Therapeutic Adherence OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 6, 2020

Record last verified: 2020-10