LeukemiaNCT00005881
Quality of Life in Children Treated for Cancer
An observational study of Leukemia and Lymphoma, run by Children's Oncology Group at 17 sites in United States.
Trial summary
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer. PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- Quality of Life Forms
- How many people
- 538 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2000to Sep 2006
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Previous treatment for cancer or currently undergoing treatment for cancer.
DISEASE CHARACTERISTICS: Prior or current diagnosis of any pediatric cancer Current chemoradiotherapy (at least 2 months since start of therapy) OR At least 1 year since prior treatment and in remission
PATIENT CHARACTERISTICS: Age: 8 to 20 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
About this study
Official title: Assessment of Health/Quality of Life in Survivors of Childhood Cancer
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer.
PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer.
Read the detailed description
OBJECTIVES: I. Assess the validity and reliability of a quality of life questionnaire (MM-QOL) that is being developed for patients with previously or currently treated childhood cancers.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (8-12 vs 13-20) and treatment (current vs previous). Patients are randomized to one of two arms of the study. Arm I (Reliability): Patients will complete the same questionnaire two weeks apart. (age 13-20 stratum closed as of 7/14/00) Arm II (Validity): Patients will complete a study questionnaire plus a Child Health Questionnaire. Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire.
PROJECTED ACCRUAL: A total of 716 patients (416 for arm I (208 for 8-12 age group and 208 for 13-20 age group) and 300 for arm II (150 for 8-12 age group and 150 for 13-20 age group)) will be accrued for this study.
- Being tested
- Quality of Life Forms
- Keywords
- recurrent childhood acute lymphoblastic leukemia, childhood Burkitt lymphoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, unspecified childhood solid tumor, protocol specific, childhood acute myeloid leukemia in remission, stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, stage I childhood small noncleaved cell lymphoma, stage I childhood large cell lymphoma, stage II childhood small noncleaved cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Recurrence, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life FormsOther
Completion of the instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life forms | Completion of the development of an instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials. Receives: Other: Quality of Life Forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
To complete the development of a self-reported, quality of life questionnaire (MM-QOL) for the pediatric oncology population.
Measured: Length of study
Secondary outcomes (2)
To see if this measure will discriminate between i) those undergoing treatment for cancer, ii) those who are survivors of cancer, and iii) a national sample of age- and sex-matched controls.
To assess the validity of a quality of life questionnaire (MM-QOL) that is being developed for survivors of childhood cancer. To see if this measure will discriminate between i) those undergoing treatment for cancer, ii) those who are survivors of cancer, and iii) a national sample of age- and sex-matched controls (data has already been collected on the latter). To compare the responses to the new scale items with those from established scales (CHQ) that tap relevant QOL domains such as emotional, social, and physical functioning.
Measured: Length of study
Test internal scale reliability
To assess the reliability of a quality of life questionnaire (MM-QOL) that is being developed for the survivors of childhood cancer. To test internal scale reliability (studies already being conducted). To assess test-retest reliability.
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2004 (estimated)
- Study startApr 2000
- Primary completionMar 2003
- Study completionSep 2006
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 Children's Oncology GroupThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Smita Bhatia, MD, MPH, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005881
- Sponsor's protocol ID
- AS972
- Other IDs
- CCG-AS972, CCG-S9702, NCI-P00-0148, CDR0000067920
- Status last verified
- Aug 2013
- First submitted
- 2 Jun 2000
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health/Quality of Life in Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT00005881
- Acronym / sponsor ID
- AS972
- Keywords
- recurrent childhood acute lymphoblastic leukemia, childhood Burkitt lymphoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- Mar 2003 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 2 Feb 2004 (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: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer.
PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer.
Detailed description
OBJECTIVES: I. Assess the validity and reliability of a quality of life questionnaire (MM-QOL) that is being developed for patients with previously or currently treated childhood cancers.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (8-12 vs 13-20) and treatment (current vs previous). Patients are randomized to one of two arms of the study. Arm I (Reliability): Patients will complete the same questionnaire two weeks apart. (age 13-20 stratum closed as of 7/14/00) Arm II (Validity): Patients will complete a study questionnaire plus a Child Health Questionnaire. Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire.
PROJECTED ACCRUAL: A total of 716 patients (416 for arm I (208 for 8-12 age group and 208 for 13-20 age group) and 300 for arm II (150 for 8-12 age group and 150 for 13-20 age group)) will be accrued for this study.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life forms | – | Other: Quality of Life FormsCompletion of the development of an instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Previous treatment for cancer or currently undergoing treatment for cancer.
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 |
|---|---|---|
| Quality of Life FormsCompletion of the instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials. | Other | Quality of life forms |
Primary outcome
Quality of life questionnaire
Time frame: Length of study
To complete the development of a self-reported, quality of life questionnaire (MM-QOL) for the pediatric oncology population.
2 secondary outcomes
To see if this measure will discriminate between i) those undergoing treatment for cancer, ii) those who are survivors of cancer, and iii) a national sample of age- and sex-matched controls.
Time frame: Length of study
Test internal scale reliability
Time frame: Length of study
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 23 Aug 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.
Smita Bhatia, MD, MPH study chair
City of Hope Medical Center
17 sites 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 Children's Oncology Group at 17 sites 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Quality of life questionnaire (time frame: Length of study). 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 23 Aug 2013.