Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia
Verified date | January 2013 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | October 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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