NCT01469754

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

November 8, 2011

Last Update Submit

May 1, 2014

Conditions

Keywords

lymphomasurvivorsposttraumatic growthposttraumatic stresslongitudinal

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic Growth

    Measured at enrollment

Secondary Outcomes (1)

  • Posttraumatic Stress Disorder (PTSD)

    Measured at Enrollment

Study Arms (1)

Lymphoma Survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lymphoma survivors who have completed initial treatment within the last 3 months

You may qualify if:

  • Diagnosis of Lymphoma (includes Waldenstrom's Macroglobulinemia)
  • Can read/write/understand English without a translator

You may not qualify if:

  • Currently Hospitalized
  • Active Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian/Weill Cornell Center for Lymphoma and Myeloma

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Regina A Jacob, MD

    WCMC Research Fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations