An observational study in Sleep Disorder and Breast Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by Samsung Medical Center · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Pre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin
Drug: Tamoxifen Oral Tablet
Patients who are scheduled for application of tamoxifen and goserelin
total sleep time
mean total sleep time per day, recorded by wrist-worn IoT device
Time frame: study enroll~12 months
walking steps and walking time
mean walking steps and walking time per day, recorded by wrist-worn IoT device
Time frame: study enroll~12 months
Pittsburg Sleep Quality Index (PSQI)
questionnaire developed to evaluate quality of sleep and sleep disorder
Time frame: study enroll~12 months
Insomnia Severity Index (ISI)
questionnaire developed to evaluate insomnia
Time frame: study enroll~12 months
Distress thermometer
well-known screening tool for psycho-social distress of cancer patients
Time frame: study enroll~12 months
Plan to share: No
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center