Anxiety DisorderNCT00956475
Quality of Life in Younger Leukemia and Lymphoma Survivors
An observational study of Anxiety Disorder and Cancer Survivor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment. PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anxiety Disorder, Cancer Survivor, Fatigue
- What is being tested?
- telephone-based intervention, questionnaire administration and assessment of therapy complications
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2011
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Records from the practice of the study investigators will be reviewed to identify patients.
DISEASE CHARACTERISTICS:
- Survivors of leukemia (i.e., acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or chronic lymphocytic leukemia) or lymphoma (i.e., non-Hodgkin lymphoma or Hodgkin lymphoma) who have received any cytotoxic or radiation therapy
- Received treatment for leukemia or lymphoma 1-10 years ago
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Quality of Life in Young Adult Survivors of Hematologic Malignancies
RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors.
Read the detailed description
OBJECTIVES:
- To collect preliminary data to determine the extent to which there is impairment in quality of life of young adult survivors of hematologic malignancies.
- To identify the most common areas of concern in these survivors.
- To explore patterns of quality-of-life impairment associated with age, gender, and type of treatment (transplant vs non-transplant) in these survivors.
OUTLINE: Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
- Conditions
- Anxiety Disorder, Cancer Survivor, Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Lymphoma
- Being tested
- telephone-based intervention, questionnaire administration, assessment of therapy complications, fatigue assessment and management, psychosocial assessment and care
- Keywords
- anxiety disorder, long-term effects secondary to cancer therapy in adults, fatigue, pain, psychosocial effects of cancer and its treatment, cancer survivor, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia
- Medical subject headings
- Anxiety Disorders, Fatigue, Leukemia, Lymphoma, Lymphoproliferative Disorders, Pain, Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
questionnaire administrationOther
Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
assessment of therapy complicationsProcedure or surgery
questionnaire via telephone
fatigue assessment and managementProcedure or surgery
questionnaire via telephone
psychosocial assessment and careProcedure or surgery
questionnaire via telephone
quality-of-life assessmentProcedure or surgery
questionnaire via telephone
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 1-10 years after treatment
Most common areas of concern
Measured: 1-10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Regan Demshar, RN, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956475
- Sponsor's protocol ID
- CASE11Z08
- Other IDs
- P30CA043703, CASE11Z08, CASE 11Z08-CC607
- Status last verified
- Aug 2011
- First submitted
- 8 Aug 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Young Adult Survivors of Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00956475
- Acronym / sponsor ID
- CASE11Z08
- Conditions
- Anxiety Disorder, Cancer Survivor, Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Lymphoma
- Keywords
- anxiety disorder, long-term effects secondary to cancer therapy in adults, fatigue, pain, psychosocial effects of cancer and its treatment, cancer survivor, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Aug 2009 (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: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors.
Detailed description
OBJECTIVES:
- To collect preliminary data to determine the extent to which there is impairment in quality of life of young adult survivors of hematologic malignancies.
- To identify the most common areas of concern in these survivors.
- To explore patterns of quality-of-life impairment associated with age, gender, and type of treatment (transplant vs non-transplant) in these survivors.
OUTLINE: Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Records from the practice of the study investigators will be reviewed to identify patients.
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 |
|---|---|---|
| telephone-based interventionPatients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone. | Behavioural | – |
| questionnaire administrationPatients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone. | Other | – |
| assessment of therapy complicationsquestionnaire via telephone | Procedure or surgery | – |
| fatigue assessment and managementquestionnaire via telephone | Procedure or surgery | – |
| psychosocial assessment and carequestionnaire via telephone | Procedure or surgery | – |
| quality-of-life assessmentquestionnaire via telephone | Procedure or surgery | – |
Primary outcome
Quality of life
Time frame: 1-10 years after treatment
Most common areas of concern
Time frame: 1-10 years after treatment
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 24 Aug 2011.
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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.
Regan Demshar, RN principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive 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 Anxiety Disorder and Cancer Survivor, run by Case Comprehensive 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 24 Aug 2011. 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?
Quality of life (time frame: 1-10 years after treatment). The study lists 2 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 24 Aug 2011.