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

Depression Clinical Trial

— FOCUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929720
• Other study ID #: OSU-09096
• Secondary ID: NCI-2012-02879
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: April 4, 2017
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Cognitive-behavioral Therapy
• Colorectal Neoplasms
• Depression
• Disease
• Esophageal Cancer
• Esophageal Neoplasms
• Fatigue
• Glioblastoma
• Glioblastoma Multiforme
• Insomnia
• Leukemia
• Lung Cancer
• Multiple Myeloma
• Ovarian Neoplasm
• Ovarian Neoplasms
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms
• Parasomnias
• Psychological Intervention
• Relapsed Lymphoma
• Sleep Disorders
• 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
• Uncertainty
• Uterine Neoplasms
• Worry

Intervention

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.

Locations

Country	Name	City	State
United States	Wexner Medical Center at The Ohio State University Department of Psychiatry	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	American Cancer Society, Inc., Lance Armstrong Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 6 weeks
Primary	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.	From baseline to 6 weeks
Primary	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.	From baseline to 6 weeks
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline

External Links

•   Center for Palliative Care