search
Back to results

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

Primary Purpose

Anxiety Disorder, Worry, Uncertainty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy for worry, uncertainty & insomnia
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder focused on measuring cancer, cancer survivors, worry, insomnia, symptoms, fatigue, depression, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wexner Medical Center at The Ohio State University Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (CBT for worry, uncertainty & insomnia)

Arm II (wait-list control)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Levels of 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 pro and anti inflammatory cytokines.
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.

Full Information

First Posted
March 13, 2013
Last Updated
April 4, 2017
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc., Lance Armstrong Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01929720
Brief Title
Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Acronym
FOCUS
Official Title
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc., Lance Armstrong Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
cancer, cancer survivors, worry, insomnia, symptoms, fatigue, depression, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (CBT for worry, uncertainty & insomnia)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (wait-list control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy for worry, uncertainty & insomnia
Other Intervention Name(s)
Cognitive-behavioral Therapy, Acceptance and Commitment Therapy, Psychological Intervention, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Intervention Description
This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.
Primary Outcome Measure Information:
Title
Changes in worry on the Penn State Worry Questionnaire
Description
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.
Time Frame
From baseline to 6 weeks
Title
Changes in sleep efficiency on the Insomnia Severity Index
Description
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.
Time Frame
From baseline to 6 weeks
Title
Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
Description
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.
Time Frame
From baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Levels of cortisol
Description
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.
Time Frame
Baseline
Title
Levels of pro and anti-inflammatory cytokines
Description
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.
Time Frame
Baseline
Title
Levels of myeloid-derived suppressor cells (MDSC)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharla Wells-Di Gregorio, Ph.D.
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wexner Medical Center at The Ohio State University Department of Psychiatry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://palliativecare.osu.edu/research/
Description
Center for Palliative Care

Learn more about this trial

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

We'll reach out to this number within 24 hrs