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
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Observational
Official Title: The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 750
Study Start Date: March 1996
Study Completion Date: March 2010
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126477

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Jean E. Sanders, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00126477     History of Changes
Other Study ID Numbers: 1098.00, FHCRC-1098.00, CDR0000434793
Study First Received: August 2, 2005
Last Updated: April 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
quality of life
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
juvenile myelomonocytic leukemia
childhood Hodgkin lymphoma
childhood lymphoblastic lymphoma
childhood large cell lymphoma
childhood small noncleaved cell lymphoma
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 29, 2014