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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00126477
First received: August 2, 2005
Last updated: April 29, 2013
Last verified: April 2013

August 2, 2005
April 29, 2013
March 1996
April 2007   (final data collection date for primary outcome measure)
  • Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
  • Cognitive capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
  • Physical capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
  • Psychosocial status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
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Complete list of historical versions of study NCT00126477 on ClinicalTrials.gov Archive Site
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Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer
The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child

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.

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.

Observational
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  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Quality of Life
  • Procedure: cognitive assessment
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
March 2010
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126477
1098.00, FHCRC-1098.00, CDR0000434793
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Jean E. Sanders, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP