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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01929720
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ohio State University Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sharla Wells-Di Gregorio, Ph.D.
Principal Investigator Affiliation Ohio State University Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Address

Wexner Medical Center at The Ohio State University Department of Psychiatry

Columbus, Ohio, 43210

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