Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Completed

CT.gov ID

NCT00896129

Collaborator

(none)

448

Enrollment

Locations

Duration (Months)

17.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.

Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Other: HRQOL Survey Packet

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

448 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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.

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Study population	Other: HRQOL Survey Packet Questionnaires

Arm

Intervention/Treatment

Study population

Other: HRQOL Survey Packet

Questionnaires

Outcome Measures

Primary Outcome Measures

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. [By the end of the study.]

Secondary Outcome Measures

Psychological wellbeing. [By the end of the study.]
Fatigue. [By the end of the study.]
Adherence to therapy issues. [By the end of the study.]
Symptom burden. [By the end of the study.]
Possible association between socio-demographic and clinical variables with patient reported health outcomes. [By the end of the study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Nuovo ospedale "Torrette"	Ancona	Italy
2	Unità Operativa Ematologica - Università degli Studi di Bari	Bari	Italy	70124
3	Ospedali Riuniti	Bergamo	Italy
4	Ist.Ematologia e Oncologia Medica L.e A. Seragnoli	Bologna	Italy
5	Sezione di Ematologia e Trapianti Spedali Civili	Brescia	Italy	21125
6	Azienda ASL di Cagliari	Cagliari	Italy	9121
7	Ospedale Ferrarotto	Catania	Italy	95124
8	Azienda Ospedaliera Pugliese Ciaccio	Catanzaro	Italy	88100
9	Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna	Ferrara	Italy	44100
10	Clinica Ematologica - Università degli Studi	Genova	Italy
11	Ematologia 1 - Centro Trapianto di Midollo	Milano	Italy	20122
12	Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"	Napoli	Italy	80131
13	Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"	Napoli	Italy	80131
14	Ospedale S. Luigi Gonzaga	Orbassano	Italy	10043
15	Ospedale Cervello	Palermo	Italy	90146
16	Azienda ASL di Pescara	Pescara	Italy	61100
17	Università di Pisa, Azienda Ospedaliera Pisana	Pisa	Italy	72100
18	Ospedale S.Maria delle Croci	Ravenna	Italy	48100
19	Ospedali Riuniti - Div. di Ematologia	Reggio Calabria	Italy	85100
20	Università La Sapienza	Roma	Italy	00100
21	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma	Italy
22	Serv. di Ematologia Ist. di Ematologia ed Endocrinologia	Sassari	Italy
23	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena	Italy	53100
24	Azienda USL 9 Treviso - U.O. di Ematologia	Treviso	Italy	31100
25	Policlinico G.B. Rossi	Verona	Italy	37134