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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116827
• Other study ID #: SMC 2018-07-014-011
• Status: Recruiting
• Start date: August 10, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Drug:
• Tamoxifen Oral Tablet
Patients who are scheduled for application of tamoxifen and goserelin

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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: 10.14694/EDBK_159069. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total sleep time	mean total sleep time per day, recorded by wrist-worn IoT device	study enroll~12 months
Primary	walking steps and walking time	mean walking steps and walking time per day, recorded by wrist-worn IoT device	study enroll~12 months
Secondary	Pittsburg Sleep Quality Index (PSQI)	questionnaire developed to evaluate quality of sleep and sleep disorder	study enroll~12 months
Secondary	Insomnia Severity Index (ISI)	questionnaire developed to evaluate insomnia	study enroll~12 months
Secondary	Distress thermometer	well-known screening tool for psycho-social distress of cancer patients	study enroll~12 months