Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients on Tamoxifen Using a Wrist-worn Internet of Things Device

• Conditions: Sleep Disorder; Breast Cancer
• Interventions: Drug: Tamoxifen Oral Tablet

• Registration Number: NCT04116827
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-08-10
• Status Verified: 2019-10
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-07
• Last Update Posted: 2019-10-07
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• diagnosed of unilateral breast cancer (stage 0 ~III)
• underwent proper cancer treatment including surgery, chemotherapy, radiation therapy
• age : 18 ~ 45
• scheduled for applying tamoxifen and goserelin

Exclusion Criteria

• need CPAP device during sleep due to sleep apnea
• under medication for restless leg syndrome
• previous history of tamoxifen
• irregular bedtime due to shift work
• diagnosed of recurrent or metastatic cancer
• have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems
• refuse to participate
• has musculoskeletal system and neurological damage and lesions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tamoxifen group	Tamoxifen Oral Tablet	Pre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin

Primary Outcome Measures

Name	Time	Method
walking steps and walking time	study enroll~12 months	mean walking steps and walking time per day, recorded by wrist-worn IoT device
total sleep time	study enroll~12 months	mean total sleep time per day, recorded by wrist-worn IoT device

Secondary Outcome Measures

Name	Time	Method
Distress thermometer	study enroll~12 months	well-known screening tool for psycho-social distress of cancer patients
Pittsburg Sleep Quality Index (PSQI)	study enroll~12 months	questionnaire developed to evaluate quality of sleep and sleep disorder
Insomnia Severity Index (ISI)	study enroll~12 months	questionnaire developed to evaluate insomnia

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of