An Observational Prospective Cohort Study Using an Actigraphy Device.
NCT ID: NCT03475433
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2018-05-15
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients
NCT03757182
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
NCT06340503
Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
NCT04593134
Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices
NCT04300842
Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer
NCT03161535
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beast cancer patients
All participants that suffer from breast cancer.
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.
Actigraphy device
Both groups will receive an actigraphy device that will passively measure their movement data.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Actigraphy device
Both groups will receive an actigraphy device that will passively measure their movement data.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Science and Technology, Taiwan
OTHER_GOV
University of Seville
OTHER
Taipei Medical University WanFang Hospital
OTHER
Taipei Medical University Hospital
OTHER
Adhera Health, Inc.
INDUSTRY
Taipei Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Syed Abdul Shabbir, Dr. MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor & Health IT Consultant
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Taipei Medical University Hospital
Taipei, Taipei City, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taipei City, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
The website of the CATCH project
Information about our research facility
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
None yet
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.