Quality of LifeNCT03106350
Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy
An observational study of Quality of Life, run by Chulabhorn Cancer Center.
Trial summary
EORTC-QLQ-30 questionnaire filled in by participants 6 times Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 28 Feb 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer
Who may be able to join
- good consciousness
- ability to understand and provide information
- no hearing impairment
- Eastern Cooperative Oncology Group performance level of 0 to 2
Who cannot join
- prior radiotherapy
About this study
Official title: 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
Read the 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
- Conditions
- Quality of Life
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | EORTC-QLQ-30 questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms experienced
symptoms experienced collected by EORTC-QLQ-30
Measured: Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy
Secondary outcomes (1)
quality of life
quality of life collected by EORTC-QLQ-30
Measured: Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Mar 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chulabhorn Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saengrawee Thanthong, Chulabhorn Cancer Center
- Investigators
- Saengrawee Thanthong, M.N.S, Principal investigator, Chulabhorn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106350
- Sponsor's protocol ID
- 13/2557
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17927558Manning-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.
PubMed 16020416Williams 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.
PubMed 14722602Sahin 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.
PubMed 27309408Deshields 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.
PubMed 24292095Roiland 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.
PubMed 22037330Liang 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.
PubMed 25730592Wu 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.
PubMed 24831042Reed 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.
PubMed 22672416
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms Experienced and Quality of Life in Patients With Breast Cancer Receiving Radiotherapy Across One Year
- ClinicalTrials.gov ID
- NCT03106350
- Acronym / sponsor ID
- 13/2557
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Chulabhorn Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EORTC-QLQ-30 questionnaire filled in by participants 6 times
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Other: QuestionnaireEORTC-QLQ-30 questionnaire |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer
Key inclusion criteria (4 listed)
- good consciousness
- ability to understand and provide information
- no hearing impairment
- Eastern Cooperative Oncology Group performance level of 0 to 2
Key exclusion criteria (1 listed)
- prior radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: EORTC-QLQ-30 QuestionnaireThe 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 | questionnaire |
Primary outcome
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
1 secondary outcome
quality of life
Time frame: Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 17927558Jim 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.
- Background: PubMed 16020416Manning-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.
- Background: PubMed 14722602Williams 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.
- Background: PubMed 27309408Sahin 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.
- Background: PubMed 24292095Deshields 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.
- Background: PubMed 22037330Roiland 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.
- Background: PubMed 25730592Liang 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.
- Background: PubMed 24831042Wu 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.
- Background: PubMed 22672416Reed 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.
- 2.1. Globocan 2012: Estimate Cancer Incidence, Mortality and Prevalence Worldwide in 2012Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saengrawee Thanthong, M.N.S principal investigator
Chulabhorn Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Chulabhorn Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms experienced (time frame: Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106350, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.