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Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106350
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Saengrawee Thanthong, Chulabhorn Cancer Center

Brief Summary:
EORTC-QLQ-30 questionnaire filled in by participants 6 times

Condition or disease Intervention/treatment
Quality of Life Other: Questionnaire

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 103 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Symptoms Experienced and Quality of Life in Patients With Breast Cancer Receiving Radiotherapy Across One Year
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
questionnaire
EORTC-QLQ-30 questionnaire
Other: 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 Name: EORTC-QLQ-30 Questionnaire




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106350


Sponsors and Collaborators
Chulabhorn Cancer Center
Investigators
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Principal Investigator: Saengrawee Thanthong, M.N.S Chulabhorn Hospital

Additional Information:
Publications:

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Responsible Party: Saengrawee Thanthong, Principal Investigator, Chulabhorn Cancer Center
ClinicalTrials.gov Identifier: NCT03106350     History of Changes
Other Study ID Numbers: 13/2557
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No