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

The Ohio State University

Status: Completed

Conditions: Cognitive-behavioral Therapy; Stage IIIB, IIIC, or IV Breast Cancer; Psychological Intervention; Glioblastoma Multiforme; Esophageal Cancer; Anxiety Disorder; Insomnia; Lung Cancer; Relapsed Lymphoma; Leukemia; Fatigue; Stage III or IV Cervical or Uterine Cancer; Sleep Disorders; Stage III or IV Colorectal Cancer; Multiple Myeloma; Worry; Ovarian Neoplasm; Stage IIIC or IV Melanoma; Depression; Uncertainty; Pain; Pancreatic Cancer

Treatments: Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT01929720

OSU-09096

NCI-2012-02879 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Arm I (CBT for worry, uncertainty & insomnia)

Experimental group

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.

Treatment:

Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia

Arm II (wait-list control)

Active Comparator group

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.

Treatment:

Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia