Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148927
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease
Acute Lymphoblastic Leukemia

Study Type : Observational
Actual Enrollment : 29 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Adult acute lymphoblastic leukemia patients

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148927

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Joseph M Brandwein, MD, FRCPC Princess Margaret Hospital, Canada

Responsible Party: University Health Network, Toronto Identifier: NCT01148927     History of Changes
Other Study ID Numbers: 09-0619-CE
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases