Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia
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Purpose
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.
| Condition |
|---|
|
Acute Lymphoblastic Leukemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia |
- 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) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 29 |
| Study Start Date: | November 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Adult acute lymphoblastic leukemia patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Long-term survivors of adult acute lymphoblastic leukemia treated with modified Dana Farber Cancer Institute ALL protocol (91-01).
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
Contacts and Locations| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Joseph M Brandwein, MD, FRCPC | Princess Margaret Hospital, Canada |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01148927 History of Changes |
| Other Study ID Numbers: | 09-0619-CE |
| Study First Received: | June 21, 2010 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013