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

NCT ID: NCT00126477

Last Updated: 2013-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-03-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Lymphoma Myelodysplastic Syndromes Quality of Life

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive assessment

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean E. Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FHCRC-1098.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000434793

Identifier Type: REGISTRY

Identifier Source: secondary_id

1098.00

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.