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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Cancer Society, Inc.
Lance Armstrong Foundation
Information provided by (Responsible Party):
Sharla Wells-Di Gregorio, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01929720
First received: March 13, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Changes in worry on the Penn State Worry Questionnaire [ Time Frame: From baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: August 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Cognitive-behavioral Therapy
  • Acceptance and Commitment Therapy
  • Psychological Intervention
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
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:
  • Cognitive-behavioral Therapy
  • Acceptance and Commitment Therapy
  • Psychological Intervention
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929720

Locations
United States, Ohio
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
  More Information

Additional Information:
No publications provided

Responsible Party: Sharla Wells-Di Gregorio, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01929720     History of Changes
Other Study ID Numbers: OSU-09096, NCI-2012-02879
Study First Received: March 13, 2013
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
cancer
cancer survivors
worry
insomnia
symptoms
fatigue
depression
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Colorectal Neoplasms
Depression
Depressive Disorder
Disease
Esophageal Neoplasms
Fatigue
Glioblastoma
Multiple Myeloma
Neoplasms, Plasma Cell
Ovarian Neoplasms
Pancreatic Neoplasms
Parasomnias
Sleep Disorders
Uterine Neoplasms
Adnexal Diseases
Astrocytoma
Behavioral Symptoms
Blood Protein Disorders
Breast Diseases
Cardiovascular Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014