Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT01148927
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.

This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:

* EORTC QLQ C30 to assess global health and major health domains

* Brief Pain Inventory (BPI)

* Personal Health Questionnaire (PHQ9) to assess psychosocial distress

* Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire

* Peripheral Neuropathy Questionnaire

The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• previously diagnosed with adult ALL or T-lymphoblastic lymphoma
• Age >/= 18
• Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
• Understand English and are able to fill out questionnaires

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)	9 months

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada