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The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.
Breast cancer is the most common malignant tumors occurring in women worldwide. Treatments include surgery, radiation therapy, chemotherapy, hormone therapy, and target therapy. As multidisciplinary treatment improves breast cancer survival, there is a growing interest in the quality of life of breast cancer survivors. Common symptoms that patients with breast cancer continue to complain of during or after their treatment include fatigue, pain, depression, sleep disorders, weight gain and hot flashes.
There are only a few studies investigating sleep problems in breast cancer patients, which mostly relied on surveys. A commonly used survey evaluation method is the Pittsburg Sleep Quality Index (PSQI). Using PSQI, one study reported that 66% of the Chinese breast cancer survivors had sleep disorders and 49% had significantly reduced sleep efficiency and time in bed. The group with sleep disorder had lower quality of life, more depression and higher overall stress than the group without sleep disorder. Another survey of breast cancer patients over 69 years old found that pain, fatigue and depression were related to sleep, and that fatigue was the strongest predictor of sleep disorders.
A recent study found that postmenopausal breast cancer patients, starting hormone therapy with aromatase inhibitor, total sleep time and sleep efficiency declined without statistical significance. However, 58% of Korean breast cancer patients are pre-menopausal patients aged 49 or younger, and thus, most patients take tamoxifen and goserelin instead of aromatase inhibitors after surgery. In this reason, results of aromatase inhibitor can not be applied in this population. As previous studies on the effects of tamoxifen on sleep were conducted retrospectively, objective comparisons of before and after applying tamoxifen are difficult and the long-term effects of tamoxifen are difficult to understand.
The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen group | Pre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen Oral Tablet | Drug | Patients who are scheduled for application of tamoxifen and goserelin |
|
| Measure | Description | Time Frame |
|---|---|---|
| total sleep time | mean total sleep time per day, recorded by wrist-worn IoT device | study enroll~12 months |
| walking steps and walking time | mean walking steps and walking time per day, recorded by wrist-worn IoT device | study enroll~12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburg Sleep Quality Index (PSQI) | questionnaire developed to evaluate quality of sleep and sleep disorder | study enroll~12 months |
| Insomnia Severity Index (ISI) | questionnaire developed to evaluate insomnia |
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Inclusion Criteria:
Exclusion Criteria:
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Female population, aged 18~45, diagnosed of unilateral breast cancer (stage 0 ~III), who underwent proper cancer treatment including surgery, chemotherapy, radiation therapy, scheduled for applying tamoxifen and goserelin
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27249683 | Background | Azim HA Jr, Davidson NE, Ruddy KJ. Challenges in Treating Premenopausal Women with Endocrine-Sensitive Breast Cancer. Am Soc Clin Oncol Educ Book. 2016;35:23-32. doi: 10.1200/EDBK_159069. | |
| 29484499 | Background | Gonzalez BD, Lu Q. Sleep disturbance among Chinese breast cancer survivors living in the USA. Support Care Cancer. 2018 Jun;26(6):1695-1698. doi: 10.1007/s00520-018-4128-y. Epub 2018 Feb 26. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| study enroll~12 months |
| Distress thermometer | well-known screening tool for psycho-social distress of cancer patients | study enroll~12 months |
| 29361424 | Result | Bhave MA, Speth KA, Kidwell KM, Lyden A, Alsamarraie C, Murphy SL, Henry NL. Effect of Aromatase Inhibitor Therapy on Sleep and Activity Patterns in Early-stage Breast Cancer. Clin Breast Cancer. 2018 Apr;18(2):168-174.e2. doi: 10.1016/j.clbc.2017.12.012. Epub 2017 Dec 27. |
| 25840384 | Result | Budhrani PH, Lengacher CA, Kip K, Tofthagen C, Jim H. An integrative review of subjective and objective measures of sleep disturbances in breast cancer survivors. Clin J Oncol Nurs. 2015 Apr;19(2):185-91. doi: 10.1188/15.CJON.185-191. |
| 29058128 | Result | Chen D, Yin Z, Fang B. Measurements and status of sleep quality in patients with cancers. Support Care Cancer. 2018 Feb;26(2):405-414. doi: 10.1007/s00520-017-3927-x. Epub 2017 Oct 23. |
| 29552751 | Result | Yfantis A, Intas G, Tolia M, Nikolaou M, Tsoukalas N, Lymperi M, Kyrgias G, Zografos G, Kontos M. Health-related quality of life of young women with breast cancer. Review of the literature. J BUON. 2018 Jan-Feb;23(1):1-6. |
| 37051646 | Derived | Yeo SM, Lim JY, Kim SW, Chae BJ, Yu J, Ryu JM, Hwang JH. Impact of Adjuvant Hormone Therapy on Sleep, Physical Activity, and Quality of Life in Premenopausal Breast Cancer: 12-Month Observational Study. J Breast Cancer. 2023 Apr;26(2):93-104. doi: 10.4048/jbc.2023.26.e11. Epub 2023 Mar 13. |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |