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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02879 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Lance Armstrong Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (CBT for worry, uncertainty & insomnia) | Experimental | 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. |
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| Arm II (wait-list control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy for worry, uncertainty & insomnia | Behavioral | This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharla Wells-Di Gregorio, Ph.D. | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wexner Medical Center at The Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. | |
| 40204663 | Derived | Wells-Di Gregorio S, Flowers S, Peng J, Marks DR, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson W, Magalang U, Baltimore S, Ancoli-Israel S. Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer. Psychooncology. 2025 Apr;34(4):e70141. doi: 10.1002/pon.70141. |
| Label | URL |
|---|---|
| Center for Palliative Care | View source |
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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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005221 | Fatigue |
| D010146 | Pain |
| D003863 | Depression |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D007938 | Leukemia |
| D008175 | Lung Neoplasms |
| D009101 | Multiple Myeloma |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| D005909 | Glioblastoma |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D035501 | Uncertainty |
| D064869 | Acceptance and Commitment Therapy |
| D000083626 | Psychosocial Intervention |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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