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

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04116827

Collaborator

(none)

Enrollment

Location

28.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder Breast Cancer	Drug: Tamoxifen Oral Tablet

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 10, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Tamoxifen Oral Tablet Patients who are scheduled for application of tamoxifen and goserelin

Arm

Intervention/Treatment

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

Drug: Tamoxifen Oral Tablet

Patients who are scheduled for application of tamoxifen and goserelin

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
Distress thermometer [study enroll~12 months]
well-known screening tool for psycho-social distress of cancer patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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