- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00126477
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jean E. Sanders, MD, Fred Hutchinson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- livskvalitet
- de novo myelodysplastiske syndromer
- tidligere behandlede myelodysplastiske syndromer
- sekundære myelodysplastiske syndromer
- akutt lymfatisk leukemi hos barn i remisjon
- barndom akutt myeloid leukemi i remisjon
- juvenil myelomonocytisk leukemi
- kronisk myelogen leukemi i barndommen
- storcellet lymfom i barndommen
- lymfoblastisk lymfom i barndommen
- barndoms små ikke-spaltede celle lymfom
- barndoms Hodgkin lymfom
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1098.00
- FHCRC-1098.00
- CDR0000434793 (Registeridentifikator: PDQ)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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