Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01148927

Enrollment

Registered

2010-06-22

Start date

2009-11-30

Completion date

2012-10-31

Last updated

2013-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results