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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-behavioral therapy for worry, uncertainty & insomnia

Intervention Type BEHAVIORAL

This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.

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.

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral therapy for worry, uncertainty & insomnia

Intervention Type BEHAVIORAL

This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive-behavioral Therapy Acceptance and Commitment Therapy Psychological Intervention Behavior Therapy Behavioral Modification Behavioral Therapy Behavioral Treatment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No