Anxiety Disorder | Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Anxiety Disorder research study
What is the primary objective of this study?
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Stage III or IV Cervical or Uterine Cancer
Stage IIIB, IIIC, or IV Breast Cancer
Stage III or IV Colorectal Cancer
Stage IIIC or IV Melanoma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. Patients participate in a Behavioral Intervention (cognitive-behavioral therapy) in which they receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5.
Arm II (wait-list control)Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. This is a wait-list comparison, so after six weeks, patients in the control group complete the behavioral (cognitive-behavioral therapy)intervention for worry, uncertainty, and insomnia.
Start Date: August 2011
Completed Date: September 2014
Primary Outcome: Changes in worry on the Penn State Worry Questionnaire
Secondary Outcome: Levels of cortisol
Study sponsors, principal investigator, and references
Principal Investigator: Sharla Wells-Di Gregorio, Ph.D.
Lead Sponsor: Ohio State University Comprehensive Cancer Center
Collaborator: American Cancer Society, Inc.