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NCT Number: NCT01929720

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

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.

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Key information

Conditions

Anxiety Disorder Adnexal Diseases Anxiety Disorders Astrocytoma Behavior Behavioral Symptoms Blood Protein Disorders Cardiovascular Diseases Cognitive-behavioral Therapy Depression Digestive System Diseases Digestive System Neoplasms Dyssomnias Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioblastoma Multiforme Glioma Gonadal Disorders Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Insomnia Leukemia Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Mental Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Nervous System Diseases Neuroectodermal Tumors Neurologic Manifestations Ovarian Diseases Ovarian Neoplasm Ovarian Neoplasms Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathological Conditions, Signs and Symptoms Psychological Intervention Relapsed Lymphoma Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stage III or IV Cervical or Uterine Cancer Stage III or IV Colorectal Cancer Stage IIIB, IIIC, or IV Breast Cancer Stage IIIC or IV Melanoma Thoracic Neoplasms Uncertainty Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases Worry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wexner Medical Center at The Ohio State University Department of Psychiatry

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cognitive-behavioral Therapy, Acceptance and Commitment Therapy, Psychological Intervention, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment

Primary outcomes

  1. Changes in worry on the Penn State Worry Questionnaire

    Time frame: 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.

  2. Changes in sleep efficiency on the Insomnia Severity Index

    Time frame: 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.

  3. Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale

    Time frame: 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 outcomes

  1. Levels of cortisol

    Time frame: 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.

  2. Levels of pro and anti-inflammatory cytokines

    Time frame: 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.

  3. Levels of myeloid-derived suppressor cells (MDSC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • Lance Armstrong Foundation

Registry information

Official study title

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

Acronym: FOCUS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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