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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lung cancer stage III or IV colorectal cancer pancreatic cancer esophageal cancer multiple myeloma leukemia stage IIIC and IV melanoma ovarian cancer stage III & IV cervical cancer stage III & IV uterine cancer stage IIIB, IIIC, and IV breast cancer glioblastoma multiforme early relapse (< 1 year) lymphoma Exclusion Criteria: co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus) neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires mania (if patient has bipolar disorder) active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (CBT for worry, uncertainty & insomnia)<br>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<br>* This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.<br>* Other names: Behavioral Treatment;|
| Active Comparator: Arm II (wait-list control)<br>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<br>* This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.<br>* Other names: Behavioral Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in worry on the Penn State Worry Questionnaire | 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. | From baseline to 6 weeks | 
| Changes in sleep efficiency on the Insomnia Severity Index | 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. | From baseline to 6 weeks | 
| Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale | 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. | From baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of cortisol | 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. | Baseline | 
| Levels of pro and anti-inflammatory cytokines | 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. | Baseline | 
| Levels of myeloid-derived suppressor cells (MDSC) | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, cancer survivors, worry, insomnia, symptoms, fatigue, depression, anxiety