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Trial record 33 of 427 for:    Taipei Medical University Hospital

An Observational Prospective Cohort Study Using an Actigraphy Device.

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ClinicalTrials.gov Identifier: NCT03475433
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Ministry of Science and Technology, Taiwan
University of Seville
Taipei Medical University WanFang Hospital
Taipei Medical University Hospital
Salumedia
Information provided by (Responsible Party):
Taipei Medical University

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.


Condition or disease Intervention/treatment
Neoplasm of Breast (Disorder) Carcinoma of Prostate (Disorder) Device: Actigraphy device

Detailed Description:

Physical inactivity is a common issue amongst breast cancer patients. Previous studies have shown that physical activity can be beneficiary to both the cancer outcomes and the quality of life.

However, most comparable studies had western populations or included some participants of Asian descent at best. Given the growing importance of effective and efficient follow-up care [1] and the lack of research on physical activity and sleep quality in relation to the Quality of Life (QoL) of cancer patients in Asian countries, the investigators aim to monitor the physical activity, sleep quality and subjective QoL of Taiwanese breast- and prostate cancer patients. Hence the investigators' main research question is: "Does physical and/or sleep activity affect the quality of life of (Taiwanese) breast and prostate cancer patients?". If this would be the case, the results might cover the bases for an intervention study aimed at improving physical and/or sleep quality in these cancer patients.

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). 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.

Lastly, the quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30). This will provide an insight in the quality of life of the subjects, which will enable the investigators to draw a conclusion whether or not physical activity and sleep quality are related to the quality of life.

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 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.

To retrieve results from the dataset, the data analysis will be divided in two parts: correlation between sleep quality and the Quality of Life, and between physical activity and the Quality of Life. Before commencing with the analysis itself, the data will be checked for outliers and missing data.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate Cancer Patients.
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : May 20, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Beast cancer patients
All participants that suffer from breast cancer.
Device: Actigraphy device
Both groups will receive an actigraphy device that will passively measure their movement data.

Prostate cancer patients
All participants that suffer from prostate cancer.
Device: Actigraphy device
Both groups will receive an actigraphy device that will passively measure their movement data.




Primary Outcome Measures :
  1. Change will be assessed on the quality of life of breast and prostate cancer patients. [ Time Frame: The time frame will be 8th day after enrolment of each respondent ]
    It will be measured using the scores of the Quality of Life questionnaire.

  2. Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients. [ Time Frame: The time frame will be daily for 8 days after enrolment of each respondent ]
    It will be measured using the physical activity data from the actigraphy device.


Secondary Outcome Measures :
  1. Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated [ Time Frame: The time frame will be 8th day after enrollment of each respondent ]
    This will be measured using a combination of the PSQI questionnaire and movement data during nighttime for the sleep quality, and the quality of life questionnaire scores.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475433


Contacts
Contact: Syed Abdul Shabbir, Dr. MD +886-2-66382736 ext 1501 drshabbir@tmu.edu.tw

Locations
Taiwan
Taipei Medical University Hospital Recruiting
Taipei, Taipei City, Taiwan, 11031
Contact: Syed Abdul Shabbir, Dr (MD)    +886-2-66382736 ext 1501    drshabbir@tmu.edu.tw   
Principal Investigator: Syed Abdul Shabbir, Dr. (MD)         
Sub-Investigator: Yu-Chuan (Jack) Li, Prof. Dr.         
Sub-Investigator: Usman Iqbal, Dr.         
Sub-Investigator: Terry Kuo, Prof. Dr.         
Sub-Investigator: Jiurn-Horng Kang, Dr.         
Sub-Investigator: Youri CB Broekhuizen         
Taipei Municipal Wanfang Hospital Recruiting
Taipei, Taipei City, Taiwan, 11696
Contact: Ruey Ho Kao, Dr. (MD)    (+886) 2 29307930    106165@w.tmu.edu.tw   
Principal Investigator: Ruey Ho Kao, Dr. (MD)         
Sponsors and Collaborators
Taipei Medical University
Ministry of Science and Technology, Taiwan
University of Seville
Taipei Medical University WanFang Hospital
Taipei Medical University Hospital
Salumedia
Investigators
Principal Investigator: Syed Abdul Shabbir, Dr. MD Associate Professor & Health IT Consultant

Additional Information:
Publications:

Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03475433     History of Changes
Other Study ID Numbers: None yet
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Participant Data (IPD) will be shared as open research data after the results have been published. All data that might identify individuals will be stripped to make sure the data is completely anonymous.
Supporting Materials: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Medical University:
Dyssomnias Medical Subject Headings [MeSH]
Cancer
Questionnaire
Survey
Sleep Disturbance
Sleep Quality
E-health
M-health
Actigraphy
Physical activity
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]

Additional relevant MeSH terms:
Disease
Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases