FindTrial
Sign In

Comparative study of self-report scales in cancer patients undergoing oral antineoplastic medications such as tyrosine kinase inhibitors

Use of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) short version and MDASI in patients with Cancer patients submitted to oral antineoplastic medications such as Tyrosine Kinase Inhibitors: a comparative study of the 2 scales

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10myxdss
Enrollment
Unknown
Registered
2022-11-07
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse events

Interventions

validate the content of the PRO-CTCAE™ items selected in the literature review, assess the acceptability of the questionnaire, assess medication adherence, verify the feasibility of the questionnaire
in the third consultation, the medication adherence scale, md anderson symptom inventory and the patient-reported outcomes version of the common terminology criteria for adverse events will be answere
In the fourth visit, the patient will answer the medication adherence scale, the md anderson symptom inventory, the patient-reported outcomes version of the common terminology criteria for adverse eve
E05.318.308.980.500

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Hospital Alemão Oswaldo Cruz
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: older than 18 years; being treated with TKI alone as anticancer therapy, orally and for 3 months or more; being diagnosed with one of three cancers: kidney, lung, or chronic myeloid leukemia; Performance status between 0 and 2, evaluated according to the Eastern Cooperative Oncologic Group – ECOG scale

Exclusion criteria

Exclusion criteria: multiple comorbidities (3 or more), partial completion of one of the data collection instruments

Design outcomes

Primary

MeasureTime frame
Assess therapeutic adherence through the measures of adherence to treatments questionnaire that will be answered in the four moments of medical consultation. We will look for associations between independent, sociodemographic and clinical variables, and dependent variables, treatment adherence and prevalent symptoms with degrees of severity.—

Secondary

MeasureTime frame
Evaluate the acceptability of the participant regarding the use of patient-reported outcomes version of the common terminology criteria for adverse events, through an acceptability questionnaire, where the acceptability percentages will be sought;To assess the feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events from the perspective of oncologists—

Countries

Brazil

Contacts

Public ContactAna Maria Pires

Universidade Federal de São Paulo

ana.tpires67@gmail.com+55(11) 5576 4430

Outcome results

None listed

Source: REBEC (via WHO ICTRP)