Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
FOCUS
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 5, 2017
April 1, 2017
3.1 years
March 13, 2013
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (3)
Levels of cortisol
Baseline
Levels of pro and anti-inflammatory cytokines
Baseline
Levels of myeloid-derived suppressor cells (MDSC)
Baseline
Study Arms (2)
Arm I (CBT for worry, uncertainty & insomnia)
EXPERIMENTALPatients 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 II (wait-list control)
ACTIVE COMPARATORPatients 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.
Interventions
This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State University Comprehensive Cancer Centerlead
- American Cancer Society, Inc.collaborator
- Lance Armstrong Foundationcollaborator
Study Sites (1)
Wexner Medical Center at The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210, United States
Related Publications (2)
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PMID: 41170811DERIVEDWells-Di Gregorio S, Flowers S, Peng J, Marks DR, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson W, Magalang U, Baltimore S, Ancoli-Israel S. Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer. Psychooncology. 2025 Apr;34(4):e70141. doi: 10.1002/pon.70141.
PMID: 40204663DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharla Wells-Di Gregorio, Ph.D.
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2013
First Posted
August 28, 2013
Study Start
August 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 5, 2017
Record last verified: 2017-04