Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Insomnia Sleep Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | September 2017 |
| Contact: | Norah L Henry, MD, PhD |
| Email: | norahh@med.umich.edu |
| Phone: | 734-936-4991 |
Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer
Women with early stage breast cancer may experience difficulty falling asleep or staying
asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia.
Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use
of medications for sleep and an overall decrease in quality of life.
The investigators have developed an internet-based website that is designed to help people
manage symptoms typically experienced by breast cancer survivors, including insomnia,
fatigue, pain and overall poor quality of life. The investigators want to learn whether this
type of treatment can reduce chronic insomnia and improve the way subjects feel using both
questionnaires and a special form of a wrist watch. This information may help the
investigators better manage sleep difficulties in subjects who experience these symptoms
after diagnosis of their breast cancer.
asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia.
Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use
of medications for sleep and an overall decrease in quality of life.
The investigators have developed an internet-based website that is designed to help people
manage symptoms typically experienced by breast cancer survivors, including insomnia,
fatigue, pain and overall poor quality of life. The investigators want to learn whether this
type of treatment can reduce chronic insomnia and improve the way subjects feel using both
questionnaires and a special form of a wrist watch. This information may help the
investigators better manage sleep difficulties in subjects who experience these symptoms
after diagnosis of their breast cancer.
Inclusion Criteria:
1. Clinical diagnosis of insomnia as identified through the screening Insomnia Severity
Index score >14
2. Insomnia present for > 30 days per patient report
3. Female gender
4. Histologically proven stage 0-III invasive carcinoma of the breast
a. Patient's must have completed primary surgical resection at least 2 weeks prior to
enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic
chemotherapy at least 6 weeks prior to enrollment in the study
5. ECOG performance status 0-2
6. Ability to operate the accelerometer (Actiwatch Spectrum Pro)
7. The patient is aware of the nature of her diagnosis, understands the study regimen,
its requirements, risks, and discomforts, and is able and willing to sign an informed
consent document
Exclusion Criteria:
1. Subjects who do not have access to the internet to use the internet-based module,
PROSPECT
2. Initiation of hormone therapy <4 weeks prior to enrollment in the study
3. Initiation of sleep aids, including over-the-counter or prescription medications
taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for < 4 weeks
prior to enrollment in the study
4. Use of medication for treatment of another sleep disorder, such as restless leg
syndrome or narcolepsy
5. History of medial or arthritic disease that could confound or interfere with
evaluation of activity level, including but not limited to inflammatory arthritis
(Rheumatoid Arthritis, Systemic Lupus Spondyloarthropathy, Psoriatric Arthritis,
Polymyalgia Rheumatica), Parkinson's disease and cancer involving the bone
6. Second or third shift workers or others with non-traditional sleep schedules
7. Serious or unstable medical condition that could likely lead to hospitalization
during the course of the study or compromise study participation
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