FOCUS: Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (CBT for worry, uncertainty & insomnia) 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. |
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.
Other Names:
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| Active Comparator: 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. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Changes in worry on the Penn State Worry Questionnaire [From baseline to 6 weeks]
A linear mixed model will be used to evaluate the change from pre to post on the Penn State Worry Questionnaire. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcomes will be log transformed in order to meet these assumptions for the mixed models.
- Changes in sleep efficiency on the Insomnia Severity Index [From baseline to 6 weeks]
A linear mixed model will be used to evaluate the change from pre to post on the Insomnia Severity Index. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then this outcome will be log transformed in order to meet these assumptions for the mixed models.
- Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale [From baseline to 6 weeks]
A linear mixed model will be used to evaluate the change from pre to post on the Intolerance of Uncertainty Scale . The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcome will be log transformed in order to meet these assumptions for the mixed models.
Secondary Outcome Measures
- Levels of cortisol [Baseline]
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and plasma and serum cortisol.
- Levels of pro and anti-inflammatory cytokines [Baseline]
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and pro and anti inflammatory cytokines.
- Levels of myeloid-derived suppressor cells (MDSC) [Baseline]
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and myeloid-derived suppressor values.
Eligibility Criteria
Criteria
Inclusion Criteria:
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lung cancer
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stage III or IV colorectal cancer
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pancreatic cancer
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esophageal cancer
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multiple myeloma
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leukemia
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stage IIIC and IV melanoma
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ovarian cancer
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stage III & IV cervical cancer
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stage III & IV uterine cancer
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stage IIIB, IIIC, and IV breast cancer
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glioblastoma multiforme
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early relapse (< 1 year) lymphoma
Exclusion Criteria:
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co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus)
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neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires
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mania (if patient has bipolar disorder)
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active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wexner Medical Center at The Ohio State University Department of Psychiatry | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
- American Cancer Society, Inc.
- Lance Armstrong Foundation
Investigators
- Principal Investigator: Sharla Wells-Di Gregorio, Ph.D., Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-09096
- NCI-2012-02879