A Study for PRO of CML in Real Word (Case-Only)

October 11, 2021 updated by: xuna

Validation Value of the Questionnaire to Assess Health-related Quality of Life in Patients With CML

Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Above 18 years of age.
  2. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
  3. Written informed consent.
  4. Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guanzhou, China
        • Recruiting
        • Department of Hematology, Nanfang Hospital, Southern Medical University,
        • Contact:
          • Department of Hematology Nanfang Hospital Southern M University
          • Phone Number: 02062787883
          • Email: 292347668@qq.com

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Above 18 years of age. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CML patient
≥18 years old CML patiente
Other: questionnaire
PHQ-9 and GAD-7 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia
Time Frame: 1 year
Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia
1 year

Collaborators and Investigators

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

Sponsor

xuna

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 (Actual)

September 22, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CML0922

Drug and device information, study documents

Studies a U.S. FDA-regulated drug 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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