Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer

Lymphoma Clinical Trial

Official title:

The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126477
• Other study ID #: 1098.00
• Secondary ID: FHCRC-1098.00CDR
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: April 29, 2013
• Start date: March 1996
• Est. completion date: March 2010

Study information

• Verified date: April 2013
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of hematologic cancer and may help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying the quality of life of adult cancer survivors who have undergone a previous bone marrow or peripheral stem cell transplant for a childhood hematologic cancer.

Description:

OBJECTIVES:

• Determine the extent to which adult cancer survivors who have undergone prior bone marrow or peripheral blood stem cell transplantation for a pediatric hematologic malignancy require ongoing health care and whether these needs change with increasing time after transplantation.

• Correlate physical capabilities, body image, physical limitations, including sexuality issues which alter or influence lifestyle, with time after transplantation in these patients.

• Determine whether cognitive abilities relative to memory and neurobehavioral ratings change with increasing time after transplantation in these patients.

• Correlate social and relationship abilities with length of time after transplantation in these patients.

OUTLINE: Patients and siblings complete a self-report quality of life questionnaire, including outcome assessments of neuroendocrine function, cognitive abilities, physical capability, and psychosocial behavior.

PROJECTED ACCRUAL: Approximately 750 patients (375 adult cancer survivors [case group] and 375 siblings [control group]) will be accrued for this study within 7 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: March 2010
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Case group

• Previously treated with an allogeneic, unrelated, syngeneic, or autologous bone marrow or peripheral blood stem cell transplantation for a hematologic malignancy = 5 years ago while enrolled on 1 of the following protocols:

• FHCRC-160.06

• FHCRC-179.07T

• FHCRC-446.03T

• FHCRC-661.04

• FHCRC-697.00

• FHCRC-796.00

• FHCRC-843.00

• Disease-free survivor

• Under 18 years of age at time of transplantation

• Any prior preparative regimen allowed

• Control group

• Sex-matched sibling within 5 years of patient's age*

• No chronic illnesses (e.g., cancer, diabetes, or asthma) that require medication

• No allergies that limit physical activity NOTE: *If such a sibling is not available, but another sibling is available, then that sibling would be asked to nominate a friend or relative of the same gender as the patient who is also within 5 years of the patient's age; the patient must consent in order for the control subject to participate

PATIENT CHARACTERISTICS:

Age

• See Disease Characteristics

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Must be able to speak, read, and write English

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

N/A

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Preleukemia
• Quality of Life

Intervention

Procedure:
• cognitive assessment

• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and = age 18
Primary	Cognitive capability of disease-free childhood transplant patients at 5 years after transplant and = age 18
Primary	Physical capability of disease-free childhood transplant patients at 5 years after transplant and = age 18
Primary	Psychosocial status of disease-free childhood transplant patients at 5 years after transplant and = age 18