Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

NCT ID: NCT01148927

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult acute lymphoblastic leukemia patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph M Brandwein, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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09-0619-CE

Identifier Type: -

Identifier Source: org_study_id

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