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

April 4, 2017 updated by: Sharla Wells-Di Gregorio, Ohio State University Comprehensive Cancer Center

Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Wexner Medical Center at The Ohio State University Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Acceptance and Commitment Therapy
  • Cognitive-behavioral Therapy
  • Psychological Intervention
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:
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Acceptance and Commitment Therapy
  • Cognitive-behavioral Therapy
  • Psychological Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 6 weeks
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.
From baseline to 6 weeks
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.
From baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.
Lance Armstrong Foundation

Investigators

  • Principal Investigator: Sharla Wells-Di Gregorio, Ph.D., Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-09096
  • NCI-2012-02879 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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