Quality of Life in Younger Leukemia and Lymphoma Survivors
Official Title
Quality of Life in Young Adult Survivors of Hematologic Malignancies
Acronym
Not provided
Organization
Case Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Aug 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008
Primary Completion Date
Sep 2010Actual
Completion Date
Aug 2011Actual
First Submitted Date
Aug 8, 2009
First Submission Date that Met QC Criteria
Aug 8, 2009
First Posted Date
Aug 11, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 23, 2011
Last Update Posted Date
Aug 24, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Case Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed 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.
Conditions Module
Conditions
Anxiety Disorder
Cancer Survivor
Fatigue
Leukemia
Long-term Effects Secondary to Cancer Therapy in Adults
Lymphoma
Lymphoproliferative Disorder
Pain
Psychosocial Effects of Cancer and Its Treatment
Small Intestine Cancer
Keywords
anxiety disorder
long-term effects secondary to cancer therapy in adults
fatigue
pain
psychosocial effects of cancer and its treatment
cancer survivor
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
48Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
telephone-based intervention
Behavioral
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.
questionnaire administration
Other
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.
assessment of therapy complications
Procedure
questionnaire via telephone
fatigue assessment and management
Procedure
questionnaire via telephone
psychosocial assessment and care
Procedure
questionnaire via telephone
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Quality of life
1-10 years after treatment
Most common areas of concern
1-10 years after treatment
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
35 Years
Standard Ages
Adult
Study Population
Records from the practice of the study investigators will be reviewed to identify patients.
Sampling Method
Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Regan Demshar, RN
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center