- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03106350
Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy
April 7, 2017 updated by: Saengrawee Thanthong, Chulabhorn Cancer Center
Symptoms Experienced and Quality of Life in Patients With Breast Cancer Receiving Radiotherapy Across One Year
EORTC-QLQ-30 questionnaire filled in by participants 6 times
Study Overview
Detailed Description
EORTC-QLQ-30 questionnaire filled in by participants 6 times
- 1st before receive radiotherapy
- 2nd after receive radiotherapy
- 3th 1 month after receive radiotherapy
- 4th 3 month after receive radiotherapy
- 5th 6 month after receive radiotherapy
- 6th 1 year after receive radiotherapy
Study Type
Observational
Enrollment (Actual)
103
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients with breast cancer
Description
Inclusion Criteria:
- good consciousness
- ability to understand and provide information
- no hearing impairment
- Eastern Cooperative Oncology Group performance level of 0 to 2
Exclusion Criteria:
- prior radiotherapy
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 |
---|---|
questionnaire
EORTC-QLQ-30 questionnaire
|
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
It is a copyrighted instrument, which has been translated and validated in over 100 languages and is used in more than 3,000 studies worldwide.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
symptoms experienced
Time Frame: Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy
|
symptoms experienced collected by EORTC-QLQ-30
|
Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy
|
quality of life collected by EORTC-QLQ-30
|
Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saengrawee Thanthong, M.N.S, Chulabhorn Hospital
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
- Wu HS, Harden JK. Symptom burden and quality of life in survivorship: a review of the literature. Cancer Nurs. 2015 Jan-Feb;38(1):E29-54. doi: 10.1097/NCC.0000000000000135.
- Jim HS, Andrykowski MA, Munster PN, Jacobsen PB. Physical symptoms/side effects during breast cancer treatment predict posttreatment distress. Ann Behav Med. 2007 Oct;34(2):200-8. doi: 10.1007/BF02872674.
- Manning-Walsh J. Social support as a mediator between symptom distress and quality of life in women with breast cancer. J Obstet Gynecol Neonatal Nurs. 2005 Jul-Aug;34(4):482-93. doi: 10.1177/0884217505278310.
- Williams SA, Schreier AM. The effect of education in managing side effects in women receiving chemotherapy for treatment of breast cancer. Oncol Nurs Forum. 2004 Jan-Feb;31(1):E16-23. doi: 10.1188/04.ONF.E16-E23.
- Sahin ZA, Tan M. Quality of Life and Symptom Experience of Breast Cancer Patients Undergoing Chemotherapy. Holist Nurs Pract. 2016 Jul-Aug;30(4):193-200. doi: 10.1097/HNP.0000000000000157.
- Deshields TL, Potter P, Olsen S, Liu J. The persistence of symptom burden: symptom experience and quality of life of cancer patients across one year. Support Care Cancer. 2014 Apr;22(4):1089-96. doi: 10.1007/s00520-013-2049-3. Epub 2013 Dec 3.
- Roiland RA, Heidrich SM. Symptom clusters and quality of life in older adult breast cancer survivors. Oncol Nurs Forum. 2011 Nov;38(6):672-80. doi: 10.1188/11.ONF.672-680.
- Liang SY, Chao TC, Tseng LM, Tsay SL, Lin KC, Tung HH. Symptom-Management Self-efficacy Mediates the Effects of Symptom Distress on the Quality of Life Among Taiwanese Oncology Outpatients With Breast Cancer. Cancer Nurs. 2016 Jan-Feb;39(1):67-73. doi: 10.1097/NCC.0000000000000244.
- Reed E, Kossler I, Hawthorn J. Quality of life assessments in advanced breast cancer: should there be more consistency? Eur J Cancer Care (Engl). 2012 Sep;21(5):565-80. doi: 10.1111/j.1365-2354.2012.01370.x. Epub 2012 Jun 4.
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)
March 1, 2015
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
February 28, 2017
Study Registration Dates
First Submitted
March 29, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 10, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 13/2557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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