An Observational Prospective Cohort Study Using an Actigraphy Device.

April 8, 2019 updated by: Taipei Medical University

An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate 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) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan, 11031
        • Taipei Medical University Hospital
      • Taipei, Taipei City, Taiwan, 11696
        • Taipei Municipal Wanfang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
The time frame will be daily for 8 days after enrolment of each respondent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The time frame will be 8th day after enrollment of each respondent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Collaborators

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

Investigators

  • Principal Investigator: Syed Abdul Shabbir, Dr. MD, Associate Professor & Health IT Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • None yet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

The anonymous (raw) data might be shared after the study itself has been finished.

IPD Sharing Access Criteria

The applications for IPD sharing will be reviewed on an individual basis by the Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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