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Sleep DisorderNCT04116827

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

An observational study of Sleep Disorder and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Sleep Disorder, Breast Cancer
What is being tested?
Tamoxifen Oral Tablet
Type of treatment
Pill or oral medicine
How many people
20 participants
Where
1 siteSouth Korea
Study dates
10 Aug 2018to 31 Dec 2020
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul

    Ji Hye Hwang, MD,PhD, 82-10-9933-2816, jhlee.hwang@skku.edu

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Tamoxifen Oral Tablet
Keywords
sleep disorder, breast cancer, pre-menopausal, tamoxifen, hormone therapy
Medical subject headings
Sleep Wake Disorders, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tamoxifen Oral TabletDrug

    Patients who are scheduled for application of tamoxifen and goserelin

Study groups in NCT04116827
Study groupRoleWhat they receive
Tamoxifen groupPre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin
Receives: Drug: Tamoxifen Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total sleep time

    mean total sleep time per day, recorded by wrist-worn IoT device

    Measured: study enroll~12 months

  2. walking steps and walking time

    mean walking steps and walking time per day, recorded by wrist-worn IoT device

    Measured: study enroll~12 months

Secondary outcomes (3)

  1. Pittsburg Sleep Quality Index (PSQI)

    questionnaire developed to evaluate quality of sleep and sleep disorder

    Measured: study enroll~12 months

  2. Insomnia Severity Index (ISI)

    questionnaire developed to evaluate insomnia

    Measured: study enroll~12 months

  3. Distress thermometer

    well-known screening tool for psycho-social distress of cancer patients

    Measured: study enroll~12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2019
  2. Study start10 Aug 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116827
Sponsor's protocol ID
SMC 2018-07-014-011
Status last verified
Oct 2019
First submitted
3 Oct 2019
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27249683

  • 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.

    PubMed 29484499

  • 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.

    PubMed 29361424

  • 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.

    PubMed 25840384

  • 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.

    PubMed 29058128

  • 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.

    PubMed 29552751

  • 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.

    PubMed 37051646

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorder and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total sleep time (time frame: study enroll~12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116827, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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