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

NCT04116827 | Unknown

• 1 other identifier: SMC 2018-07-014-011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Breast Cancer

Keywords

sleep disorder; breast cancer; pre-menopausal; tamoxifen; hormone therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Pittsburg Sleep Quality Index (PSQI)

  study enroll~12 months

• Insomnia Severity Index (ISI)

  study enroll~12 months

• Distress thermometer

  study enroll~12 months

Study Arms (1)

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

Interventions

Tamoxifen Oral Tablet DRUG

Patients who are scheduled for application of tamoxifen and goserelin

Tamoxifen group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 27249683 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.

  PMID: 29484499 BACKGROUND

• 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.

  PMID: 29361424 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.

  PMID: 25840384 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.

  PMID: 29058128 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.

  PMID: 29552751 RESULT

• 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.

  PMID: 37051646 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical and Rehabilitation Medicine

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: August 10, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)