Hodgkin's DiseaseNCT00598728
Quality of Life Among Survivors of Hodgkin Lymphoma
An observational study of Hodgkin's Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- Quality of Life Questionaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be recruited from over 800 patients who were enrolled on IRB approved protocols for the firstline treatment of HL between 1975-2000.
Who may be able to join
- Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69).
- English speaking
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Global Assessment of Medical Morbidities and Quality of Life Among Survivors of Hodgkin Lymphoma
The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life.
- Conditions
- Hodgkin's Disease
- Being tested
- Quality of Life Questionaires
- Keywords
- Survivors, Quality of Life
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionairesBehavioural
A patient questionnaire, which includes questions on medical morbidities and QOL, will be mailed to participants.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Hodgkin lymphoma Survivors Receives: Behavioral: Quality of Life Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of late medical complications among HL survivors
Measured: conclusion of study
Secondary outcomes (1)
To study the effect of HL and its treatment on QOL among HL survivors.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Straus, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598728
- Sponsor's protocol ID
- 05-041
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2008
- Last updated
- 27 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Assessment of Medical Morbidities and Quality of Life Among Survivors of Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00598728
- Acronym / sponsor ID
- 05-041
- Conditions
- Hodgkin's Disease
- Keywords
- Survivors, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2008 (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.
The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Quality of Life QuestionairesHodgkin lymphoma Survivors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited from over 800 patients who were enrolled on IRB approved protocols for the firstline treatment of HL between 1975-2000.
Key inclusion criteria (2 listed)
- Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69).
- English speaking
Key exclusion criteria (1 listed)
- None
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 QuestionairesA patient questionnaire, which includes questions on medical morbidities and QOL, will be mailed to participants. | Behavioural | 1 |
Primary outcome
To evaluate the prevalence of late medical complications among HL survivors
Time frame: conclusion of study
1 secondary outcome
To study the effect of HL and its treatment on QOL among HL survivors.
Time frame: conclusion 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 27 Apr 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
David Straus, MD principal investigator
Memorial Sloan Kettering 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 Hodgkin's Disease, run by Memorial Sloan Kettering 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 27 Apr 2016. 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?
To evaluate the prevalence of late medical complications among HL survivors (time frame: conclusion 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 27 Apr 2016.