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Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01148927
Collaborator
(none)
29
Enrollment
1
Location
35
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Nov 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Oct 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Adult acute lymphoblastic leukemia patients

    Outcome Measures

    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) [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Joseph M Brandwein, MD, FRCPC, Princess Margaret Hospital, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01148927
    Other Study ID Numbers:
    • 09-0619-CE
    First Posted:
    Jun 22, 2010
    Last Update Posted:
    Jan 11, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Jan 11, 2013