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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00126477
Collaborator
National Cancer Institute (NCI) (NIH)
750
1
168
4.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cognitive assessment
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
Official Title:
The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child
Study Start Date :
Mar 1, 1996
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Mar 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18 []

  2. Cognitive capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18 []

  3. Physical capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18 []

  4. Psychosocial status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024

Sponsors and Collaborators

  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jean E. Sanders, MD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00126477
Other Study ID Numbers:
  • 1098.00
  • FHCRC-1098.00
  • CDR0000434793
First Posted:
Aug 4, 2005
Last Update Posted:
May 1, 2013
Last Verified:
Apr 1, 2013

Study Results

No Results Posted as of May 1, 2013