LeukemiaNCT00126477
Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer
An observational study of Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- What is being tested?
- cognitive assessment, management of therapy complications and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: 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.
Read the 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.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Quality of Life
- Being tested
- cognitive assessment, management of therapy complications, psychosocial assessment and care, quality-of-life assessment
- Keywords
- 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
- Medical subject headings
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Juvenile, Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentProcedure or surgery
management of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startMar 1996
- Primary completionApr 2007
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jean E. Sanders, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126477
- Sponsor's protocol ID
- 1098.00
- Other IDs
- FHCRC-1098.00, CDR0000434793
- Status last verified
- Apr 2013
- First submitted
- 2 Aug 2005
- Last updated
- 1 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child
- ClinicalTrials.gov ID
- NCT00126477
- Acronym / sponsor ID
- 1098.00
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Quality of Life
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1996
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive assessment | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean E. Sanders, MD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.