An Observational Prospective Cohort Study Using an Actigraphy Device.

NCT03475433 | Completed

• 1 other identifier: None yet
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device. This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.

Conditions

Neoplasm of Breast (Disorder); Carcinoma of Prostate (Disorder)

Keywords

Cancer; Questionnaire; Survey; Sleep Disturbance; Sleep Quality; E-health; M-health; Actigraphy; Physical activity; Dyssomnias Medical Subject Headings [MeSH]; Sleep Wake Disorders [MeSH]; Parasomnias [MeSH]; Nervous System Diseases [MeSH]; Mental Disorders [MeSH]; Neurologic Manifestations [MeSH]; Signs and Symptoms [MeSH]; Telemedicine [MeSH]; Actigraphy [MeSH]; Quality of Life [MeSH]; Motor Activity [MeSH]; Breast Neoplasms [MeSH]; Prostatic Neoplasms [MeSH]; Sleep Hygiene [MeSH]; Neoplasms [MeSH]

Outcome Measures

Primary Outcomes (2)

• Change will be assessed on the quality of life of breast and prostate cancer patients.

  It will be measured using the scores of the Quality of Life questionnaire.

  The time frame will be 8th day after enrolment of each respondent

• Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.

  It will be measured using the physical activity data from the actigraphy device.

  The time frame will be daily for 8 days after enrolment of each respondent

Secondary Outcomes (1)

• Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated

  The time frame will be 8th day after enrollment of each respondent

Study Arms (2)

Beast cancer patients

All participants that suffer from breast cancer.

Device: Actigraphy device

Prostate cancer patients

All participants that suffer from prostate cancer.

Device: Actigraphy device

Interventions

Actigraphy device DEVICE

Both groups will receive an actigraphy device that will passively measure their movement data.

Beast cancer patients; Prostate cancer patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected with the help of oncologists in Taiwanese hospitals, therefore all participants will be Taiwanese residents and patients of either one of the desired hospital locations in Taipei. All participants are also either breast cancer or prostate cancer patients, with a minimum age of 20 years.

You may qualify if:

• The patient:
• Is an outpatient receiving evaluation, treatment, or follow-up care at either one of the desired hospital locations in Taipei.
• Has been diagnosed with prostate or breast cancer within the past year.
• Is currently receiving treatment for the cancer.
• Is at least 20 years old.
• Is able to understand Mandarin Chinese.
• Gives informed consent to participate.
• scores at least 26 on the Mini-Mental State Examination (MMSE).
• Has a score 45 or higher on the Berg Balance Scale test.

You may not qualify if:

• The patient:
• Cannot understand the intent of the study.
• scores lower than 26 on the Mini-Mental State Examination (MMSE).
• Is not fit to participate, as believed by their current treating physician.
• Is physical unable to walk.
• Has a score of \<45 on the Berg Balance Scale test.
• Refuses to participate.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator
• University of Seville: collaborator
• Taipei Medical University WanFang Hospital: collaborator
• Taipei Medical University Hospital: collaborator
• Adhera Health, Inc.: collaborator

Study Sites (2)

Taipei Medical University Hospital

Taipei, Taipei City, 11031, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taipei City, 11696, Taiwan

Location

Related Publications (12)

• Robison LL, Demark-Wahnefried W. Cancer survivorship: focusing on future research opportunities. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):1994-5. doi: 10.1158/1055-9965.EPI-11-0837. No abstract available.

  PMID: 21980006 BACKGROUND

• Monga U, Kerrigan AJ, Thornby J, Monga TN. Prospective study of fatigue in localized prostate cancer patients undergoing radiotherapy. Radiat Oncol Investig. 1999;7(3):178-85. doi: 10.1002/(SICI)1520-6823(1999)7:33.0.CO;2-0.

  PMID: 10406060 BACKGROUND

• Shin WK, Song S, Jung SY, Lee E, Kim Z, Moon HG, Noh DY, Lee JE. The association between physical activity and health-related quality of life among breast cancer survivors. Health Qual Life Outcomes. 2017 Jun 30;15(1):132. doi: 10.1186/s12955-017-0706-9.

  PMID: 28666465 BACKGROUND

• Inbar C, Ety B, Ayala H, Tamer P. The mental health of breast cancer survivors and their adolescent daughters. Psychooncology. 2013 Jun;22(6):1236-41. doi: 10.1002/pon.3127. Epub 2012 Jul 4.

  PMID: 22764063 BACKGROUND

• Toivonen KI, Tamagawa R, Speca M, Stephen J, Carlson LE. Open to Exploration? Association of Personality Factors With Complementary Therapy Use After Breast Cancer Treatment. Integr Cancer Ther. 2018 Sep;17(3):785-792. doi: 10.1177/1534735417753539. Epub 2018 Jan 24.

  PMID: 29361852 BACKGROUND

• Szymlek-Gay EA, Richards R, Egan R. Physical activity among cancer survivors: a literature review. N Z Med J. 2011 Jun 24;124(1337):77-89.

  PMID: 21946880 BACKGROUND

• Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.

  PMID: 20052559 BACKGROUND

• Meneses-Echavez JF, Gonzalez-Jimenez E, Ramirez-Velez R. Supervised exercise reduces cancer-related fatigue: a systematic review. J Physiother. 2015 Jan;61(1):3-9. doi: 10.1016/j.jphys.2014.08.019. Epub 2014 Dec 13.

  PMID: 25511250 BACKGROUND

• Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.

  PMID: 12547047 BACKGROUND

• Costa AR, Fontes F, Pereira S, Goncalves M, Azevedo A, Lunet N. Impact of breast cancer treatments on sleep disturbances - A systematic review. Breast. 2014 Dec;23(6):697-709. doi: 10.1016/j.breast.2014.09.003. Epub 2014 Oct 11.

  PMID: 25307946 BACKGROUND

• Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.

  PMID: 16155782 BACKGROUND

• Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.

  PMID: 18653703 BACKGROUND

Related Links

• The website of the CATCH project
• Information about our research facility

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms; Parasomnias; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior

Study Officials

• Syed Abdul Shabbir, Dr. MD

  Associate Professor & Health IT Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 23, 2018
• Study Start: May 15, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: April 10, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The anonymous (raw) data might be shared after the study itself has been finished.
• Access Criteria: The applications for IPD sharing will be reviewed on an individual basis by the Principal Investigator.

Locations

TW (2)