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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00956475
Other study ID # CASE11Z08
Secondary ID P30CA043703CASE1
Status Completed
Phase Phase 1
First received August 8, 2009
Last updated August 23, 2011
Start date October 2008
Est. completion date August 2011

Study information

Verified date August 2011
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors.


Description:

OBJECTIVES:

- To collect preliminary data to determine the extent to which there is impairment in quality of life of young adult survivors of hematologic malignancies.

- To identify the most common areas of concern in these survivors.

- To explore patterns of quality-of-life impairment associated with age, gender, and type of treatment (transplant vs non-transplant) in these survivors.

OUTLINE: Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility DISEASE CHARACTERISTICS:

- Survivors of leukemia (i.e., acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or chronic lymphocytic leukemia) or lymphoma (i.e., non-Hodgkin lymphoma or Hodgkin lymphoma) who have received any cytotoxic or radiation therapy

- Received treatment for leukemia or lymphoma 1-10 years ago

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Behavioral:
telephone-based intervention
Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
Other:
questionnaire administration
Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
Procedure:
assessment of therapy complications
questionnaire via telephone
fatigue assessment and management
questionnaire via telephone
psychosocial assessment and care
questionnaire via telephone
quality-of-life assessment
questionnaire via telephone

Locations

Country Name City State
United States Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life 1-10 years after treatment No
Primary Most common areas of concern 1-10 years after treatment No
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