Clinical trial NCT01929720: Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Official title: Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Lance Armstrong Foundation
First posted: 2013-08-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in worry on the Penn State Worry Questionnaire
timeFrame: From baseline to 6 weeks
measure: Changes in sleep efficiency on the Insomnia Severity Index
timeFrame: From baseline to 6 weeks
measure: Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
timeFrame: From baseline to 6 weeks
Secondary outcomes:
measure: Levels of cortisol
timeFrame: Baseline
measure: Levels of pro and anti-inflammatory cytokines
timeFrame: Baseline
measure: Levels of myeloid-derived suppressor cells (MDSC)
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Wexner Medical Center at The Ohio State University Department of Psychiatry
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sharla Wells-Di Gregorio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: