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| ID | Type | Description | Link |
|---|---|---|---|
| UMCC 2013.098 | Other Identifier | University of Michigan Cancer Center |
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| Name | Class |
|---|---|
| Damon Runyon Cancer Research Foundation | OTHER |
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Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actigraphy | Postmenopausal women starting aromatase inhibitor therapy will undergo assessment with questionnaires and actigraphy before starting AI therapy and after 3 months of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting an actigraphy study with breast cancer patients | Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements. | We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality. | 3 months |
| Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy |
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Inclusion Criteria:
Exclusion Criteria:
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University of Michigan Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| D005221 | Fatigue |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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We will analyze the change in sleep, pain, fatigue, and symptom severity index between baseline and 12 weeks. We will correlate changes in symptoms from baseline to 12 weeks with actigraphy activity. |
| 3 Months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |