NCT03106350

Brief Summary

EORTC-QLQ-30 questionnaire filled in by participants 6 times

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

March 29, 2017

Last Update Submit

April 7, 2017

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • symptoms experienced

    symptoms experienced collected by EORTC-QLQ-30

    Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy

Secondary Outcomes (1)

  • quality of life

    Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy

Study Arms (1)

questionnaire

EORTC-QLQ-30 questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

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.

Also known as: EORTC-QLQ-30 Questionnaire
questionnaire

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with breast cancer

You may qualify if:

  • good consciousness
  • ability to understand and provide information
  • no hearing impairment
  • Eastern Cooperative Oncology Group performance level of 0 to 2

You may not qualify if:

  • prior radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 17927558BACKGROUND

  • 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.

    PMID: 16020416BACKGROUND

  • 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.

    PMID: 14722602BACKGROUND

  • 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.

    PMID: 27309408BACKGROUND

  • 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.

    PMID: 24292095BACKGROUND

  • 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.

    PMID: 22037330BACKGROUND

  • 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.

    PMID: 25730592BACKGROUND

  • 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.

    PMID: 24831042BACKGROUND

  • 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.

    PMID: 22672416BACKGROUND

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Saengrawee Thanthong, M.N.S

    Chulabhorn Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 10, 2017

Study Start

March 1, 2015

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

April 10, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share