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Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.


OBJECTIVES:

Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid
Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First
Line Therapy.

Secondary evaluation of:

- Psychological wellbeing.

- Fatigue.

- Adherence to therapy issues.

- Symptom burden.

- Possible association between social-demographic and clinical variables with patient
reported health outcomes.

OUTLINE:This is a multicenter study.

SAMPLE SIZE:

Sample size estimation has not been performed considering the nature of the study and the
lack of preliminary data to hypothesize the number of possible eligible patients in each
center.

DURATION OF THE STUDY:

The recruitment period is estimated in approximately 6 to 12 months.


Inclusion Criteria:



- Age 18 years.

- CML patients meeting the following criteria:

- Started IM therapy in the early chronic phase (ECP).

- Have been undergoing treatment with IM, as first line therapy, for at least
three years regardless of the current prescribed dose of IM.

- In complete cytogenetic response (CCgR) and no clinical evidence of disease
progression to accelerated phase (AP) or blast crisis (BC).

- Able to read and write Italian.

- Freedom from psychiatric conditions that may confound HRQOL evaluation.

- Informed consent provided.

Exclusion Criteria:

- CML patients who were initially diagnosed in the AP or BC or those who started
therapy with IM in the late chronic phase (LCP).

- Having received any kind of treatment prior to IM therapy (except for hydroxyurea
and/or anagrelide).

- Patients with a new primary malignancy.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Authority:

Italy: Ethics Committee

Study ID:

QOL-CML0208

NCT ID:

NCT00896129

Start Date:

March 2009

Completion Date:

December 2009

Related Keywords:

  • Chronic Myeloid Leukemia
  • Health Outcomes Research
  • CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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