Carcinoma of Prostate (Disorder) Clinical Trial
Official title:
An Observational Prospective Cohort Study About Quality of Life in Relation to the Physical Activity of Taiwanese Breast and Prostate Cancer Patients.
NCT number | NCT03475433 |
Other study ID # | None yet |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2018 |
Est. completion date | August 31, 2018 |
Verified date | March 2018 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University Hospital | Taipei | Taipei City |
Taiwan | Taipei Municipal Wanfang Hospital | Taipei | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University | Ministry of Science and Technology, Taiwan, Salumedia, Taipei Medical University Hospital, Taipei Medical University WanFang Hospital, University of Seville |
Taiwan,
Costa AR, Fontes F, Pereira S, Gonçalves 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. Review. — View Citation
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. — View Citation
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. — View Citation
Meneses-Echávez JF, González-Jiménez E, Ramírez-Vélez 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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Speck RM, Courneya KS, Mâsse 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. Review. Erratum in: J Cancer Surviv. 2011 Mar;5(1):112. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated | 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 |