Clinical trialNACompleted
Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- August 2011
- Expected end
- September 2014
- Enrollment
- 33 participants
- Sites
- 1
- Primary outcomes
- Changes in worry on the Penn State Worry Questionnaire; Changes in sleep efficiency on the Insomnia Severity Index; Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
- Sponsor
- Other
- Results posted
- No
- Last update
- 5 April 2017
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia intervention to determine the impact of this intervention on patient worry, intolerance of uncertainty, and sleep efficiency. II. Explore the underlying endocrine and immune mechanisms responsible for a specific symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Patients also receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Blood draw is optional. ARM II: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Blood draw is also optional. This is a wait-list control arm, so patients in this arm, after a six-week period of treatment as usual with their oncologist, then receive the intervention.