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The study was terminated because of low accrual.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROSPECT | Experimental | Participants who have received treatment for early stage breast cancer and who experience chronic insomnia as assessed by difficulty sleeping for >30 days with an insomnia severity index score of >14. Participants will complete baseline symptom questionnaires and actigraphy, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 6 weeks. Participants will then repeat questionnaires and actigraphy at 6 weeks and questionnaires at 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROSPECT | Behavioral | PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms, including insomnia, through non-pharmacologic approaches. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index | Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Disturbance as measured by Actigraphy | Sleep disturbance will be measured through the use of actigraphy watches to be worn for 7 days at baseline and 7 days after 6 weeks of the intervention | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in use of sleep aids | A review of the patient's medication list will be conducted at baseline and 6 weeks to determine change in use of sleep aids for chronic insomnia during study participation | 6 weeks |
| Change in Quality of Life |
Inclusion Criteria:
Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score >14
Insomnia present for > 30 days per patient report
Female gender
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
ECOG performance status 0-2
Ability to operate the accelerometer (Actiwatch Spectrum Pro)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel F Hayes, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unvisterity of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Quality of life will be measured through the use of a validated survey called Functional Assessment of Cancer Therapy-Endocrine Symptoms
| 6 weeks |
| Change in Fear of Cancer Recurrence | Fear of recurrence will be measured through the use of a validated survey called Assessment of Cancer Survivors | 6 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |