LymphomaCLEAR StressNCT01469754
Longitudinal Survey Analysis in Lymphoma Survivors
An observational study of Lymphoma and Posttraumatic Stress Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer survivors. PTSD is known to cause problems with anxiety, depression, and quality of life. Furthermore, there is little treatment available for cancer survivors who suffer from PTSD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Posttraumatic Stress Disorder, Posttraumatic Growth
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lymphoma survivors who have completed initial treatment within the last 3 months
Who may be able to join
- Diagnosis of Lymphoma (includes Waldenstrom's Macroglobulinemia)
- Can read/write/understand English without a translator
Who cannot join
- Currently Hospitalized
- Active Psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian/Weill Cornell Center for Lymphoma and Myeloma
New York, New York, 10065
About this study
Official title: Coping With Lymphoma to Enhance Adjustment and Reduce Stress in Lymphoma Survivors
Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer survivors. PTSD is known to cause problems with anxiety, depression, and quality of life. Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.
Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer survivors. It is a positive psychological phenomenon that occurs in some people who have suffered a traumatic event--the people who are able to note a "greater appreciation for life", a "stronger relationship with their family/friends," or a "new found level of spirituality" are examples of instances of posttraumatic growth.
Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a study designed to compare the development of PTSD versus the development of Posttraumatic Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment. The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of PTSD symptoms in the survivor.
- Keywords
- lymphoma, survivors, posttraumatic growth, posttraumatic stress, longitudinal
- Medical subject headings
- Lymphoma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma Survivors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Growth
Measured: Measured at enrollment
Secondary outcomes (1)
Posttraumatic Stress Disorder (PTSD)
Measured: Measured at Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regina A Jacob, MD, Principal investigator, WCMC Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469754
- Sponsor's protocol ID
- 1107011786
- Acronym
- CLEAR Stress
- Status last verified
- May 2014
- First submitted
- 8 Nov 2011
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Lymphoma to Enhance Adjustment and Reduce Stress in Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT01469754
- Acronym / sponsor ID
- CLEAR Stress / 1107011786
- Keywords
- lymphoma, survivors, posttraumatic growth, posttraumatic stress, longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Nov 2011 (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.
Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer survivors. PTSD is known to cause problems with anxiety, depression, and quality of life. Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.
Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer survivors. It is a positive psychological phenomenon that occurs in some people who have suffered a traumatic event--the people who are able to note a "greater appreciation for life", a "stronger relationship with their family/friends," or a "new found level of spirituality" are examples of instances of posttraumatic growth.
Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a study designed to compare the development of PTSD versus the development of Posttraumatic Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment. The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of PTSD symptoms in the survivor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoma Survivors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lymphoma survivors who have completed initial treatment within the last 3 months
Key inclusion criteria (2 listed)
- Diagnosis of Lymphoma (includes Waldenstrom's Macroglobulinemia)
- Can read/write/understand English without a translator
Key exclusion criteria (2 listed)
- Currently Hospitalized
- Active Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posttraumatic Growth
Time frame: Measured at enrollment
1 secondary outcome
Posttraumatic Stress Disorder (PTSD)
Time frame: Measured at Enrollment
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 5 May 2014.
- WCMC Link to Study DescriptionLink 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.
Regina A Jacob, MD principal investigator
WCMC Research Fellow
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 Lymphoma and Posttraumatic Stress Disorder, run by Weill Medical College of Cornell University 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 2 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 5 May 2014. 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?
Posttraumatic Growth (time frame: Measured at enrollment). 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 5 May 2014.