NCT01929720

Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors

Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anxiety Disorder
• Worry
• Uncertainty
• Sleep Disorders
• Insomnia
• Fatigue
• Pain
• Depression
• Cognitive-behavioral Therapy
• Psychological Intervention
• Esophageal Cancer
• Pancreatic Cancer
• Leukemia
• Lung Cancer
• Multiple Myeloma
• Ovarian Neoplasm
• Stage III or IV Cervical or Uterine Cancer
• Stage IIIB, IIIC, or IV Breast Cancer
• Glioblastoma Multiforme
• Relapsed Lymphoma
• Stage III or IV Colorectal Cancer
• Stage IIIC or IV Melanoma

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral therapy for worry, uncertainty & insomnia	This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-08-28
• Last updated: 2017-04-05

Locations

1 site across 1 country: United States