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

Status

Completed

Conditions

Intervention / Treatment

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:
  • EORTC-QLQ-30 Questionnaire

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.

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

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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