Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Rare Diseases

Lung Neoplasms

Anxiety Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Breast Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Depression

Depressive Disorder

Fatigue

Ovarian Neoplasms

Lymphoma

Leukemia

Melanoma

Parasomnias

Glioblastoma

Pain

Uterine Neoplasms

Sleep Initiation and Maintenance Disorders

Sleep Wake Disorders

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Endocrine Gland Neoplasms

Endocrine System Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Sleep Disorders, Intrinsic

Dyssomnias

Neurologic Manifestations

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Uterine Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Lymphosarcoma

Neuroepithelioma

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.

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.

This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.

Cognitive-behavioral therapy for worry, uncertainty & insomnia

Sharla Wells-Di Gregorio, Ph.D.

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.

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

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

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.

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.

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.

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.

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.

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.

American Cancer Society, Inc.

Lance Armstrong Foundation

Ohio State University Comprehensive Cancer Center

Principal Investigator

Spots Global Cancer Trial Database for stage iiib, iiic, or iv breast cancer