Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Breast Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Chronic Pain, Depression, Depression, Insomnia Sleep Studies, Other Indications, Brain Cancer, Blood Cancer, Lymphoma, Gastrointestinal, Hematology, Hematology, Leukemia, Pancreatic Cancer |
| Therapuetic Areas: | Gastroenterology, Hematology, Musculoskeletal, Oncology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2017 |
| Start Date: | August 2011 |
| End Date: | September 2014 |
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
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.
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.
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.
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.
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
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