Clinical trial · Observational
Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients on Tamoxifen Using a Wrist-worn Internet of Things Device
Analysis of Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients After Taking Tamoxifen Using a Wrist-worn Internet of Things Device
NCT04116827CI-TRIAL-00041014unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sleep Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen Oral Tablet | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tamoxifen group
- description
- Pre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin
- interventionNames
- Drug: Tamoxifen Oral Tablet
Primary outcomes (2)
- measure
- total sleep time
- timeFrame
- study enroll~12 months
- description
- mean total sleep time per day, recorded by wrist-worn IoT device
- measure
- walking steps and walking time
- timeFrame
- study enroll~12 months
- description
- mean walking steps and walking time per day, recorded by wrist-worn IoT device
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDAzim 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
- BACKGROUNDGonzalez 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
- RESULTBhave 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
- RESULTBudhrani 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
- RESULTChen 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
- RESULTYfantis 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
- DERIVEDYeo 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