NCT05092048

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 25, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 22, 2021

Last Update Submit

October 11, 2021

Conditions

CML (Chronic Myelogenous Leukemia)

Outcome Measures

Primary Outcomes (1)

  • Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia

    Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia

    1 year

Study Arms (1)

CML patient

≥18 years old CML patiente

Other: questionnaire

Interventions

questionnaireOTHER

PHQ-9 and GAD-7 questionnaire

CML patient

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou, China

RECRUITING

Related Publications (1)

  • Chen H, Wen Y, Zeng Y, Lin L, Sun B, Zhu H, He H, Wang X, Zou W, Zheng C, Zheng L, Huang J, Pang L, Huang J, Zhang Y, Lin H, Liu Z, Zhu W, Wang Q, Zhou X, Liu X, Qu H, Liu Z, Du X, Xu N. Patient Versus Physician Perspective in the Management of Chronic Myeloid Leukemia During Treatment with Tyrosine Kinase Inhibitors. Oncol Ther. 2024 Mar;12(1):131-145. doi: 10.1007/s40487-023-00255-2. Epub 2023 Dec 16.

    PMID: 38104036DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

na xu, doctor

CONTACT

02062787883292347668@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 25, 2021

Study Start

September 22, 2021

Primary Completion

September 30, 2022

Study Completion

October 1, 2022

Last Updated

October 25, 2021

Record last verified: 2021-09

Locations

CN(1)