Clinical trial NCT03475433: An Observational Prospective Cohort Study Using an Actigraphy Device.
Official title: An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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]
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: University of Seville
name: Taipei Medical University WanFang Hospital
name: Taipei Medical University Hospital
name: Adhera Health, Inc.
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change will be assessed on the quality of life of breast and prostate cancer patients.
timeFrame: The time frame will be 8th day after enrolment of each respondent
measure: Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.
timeFrame: The time frame will be daily for 8 days after enrolment of each respondent
Secondary outcomes:
measure: Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated
timeFrame: The time frame will be 8th day after enrollment of each respondent
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
state: Taipei City
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
state: Taipei City
Study officials:
affiliation: Associate Professor & Health IT Consultant
name: Syed Abdul Shabbir, Dr. MD
role: PRINCIPAL_INVESTIGATOR
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