- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03357744
The Distress-barometer: Face-to-face Interviews or Written Self-report Questionnaires?
Face-to-face Interviews or Written Self-report Questionnaires: The Distress-barometer as a Screening Instrument for Psychosocial Complaints in Patients With Breast Cancer
Breast cancer is the most prevalent cancer among women worldwide [1]. 5 years after diagnosis, up to 87% survives. A substantial group of these survivors report reduced physical, psycho social and cognitive functioning. Therefore, it is increasingly important to screen for distress, both during and after treatment. The Distress Barometer (DB) is a valid, short screening instrument, used to detect elevated levels of distress in patients with cancer. It can be used either in a self-report questionnaire or in an interview format.
Although the DB is used in different ways, it remains unclear whether both assessment methods would generate similar results, and which format is most suitable to represent the actual level of distress. Existing literature on the DB lacks a systematic description of the relationship between the method of assessment and the patients' responses. This study questions whether the written and interview variants of the DB reveal different results in the same patients with breast cancer.
Study Overview
Detailed Description
Objective:
This study questions whether the written and interview variants of the DB reveal different results in the same patients with breast cancer.
Participants:
Participants were female breast cancer patients who received their diagnosis about three years before the study. Thirty patients received follow-up care in Ziekenhuis Oost-Limburg (ZOL). An additional twenty-nine patients were included in the KLIMOP-study and recruited in three Belgian hospitals (ZOL, University Hospital Leuven, Jessa Ziekenhuis). Patients were included through either clinical practice or the KLIMOP-study. All participating patients had to be able to read and understand Dutch and signed informed consent. In total, 59 patients took part in the study.
Data collection:
Two weeks after the face-to-face interview, patients with breast cancer will be provided with a written version of the DB questionnaire together with a prepaid envelop in order to evaluate the differences in written and oral versions of the DB.
Data management:
Data collection and data entries will be done by the PI and an assisting data manager. All patient data will be coded and anonymized. All other authors will have full access to the coded data (including statistical reports and tables) in the study and will be able to take responsibility for the integrity of the data and the accuracy of the data analysis.
Statistical analysis A chi-square test, accuracy and kappa statistic were performed to compare the dichotomized results of the DB between the interviews and questionnaires. Furthermore, paired t-tests were applied to compare the mean scores coming from interview and questionnaire for the CCS and for the DT.
Ethics:
This study is part of the ongoing KLIMOP-study and current clinical practice of ZOL. The study was added in the KLIMOP-study through an amendment to the Medical Ethics Committee S52097 / ML6279 (University Hospital Leuven) and a new study protocol was submitted to and approved by the Medical Ethics Committee of ZOL 16/050U.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- breast cancer, diagnosed 3 years ago
Exclusion Criteria:
- dementia
- no thorough command of Dutch
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress agreement between written and oral form of the questionnaire 'Distress Barometer'.
Time Frame: 2 weeks
|
agreement between different assesment methods of distress barometer
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Marjan van den Akker, PhD, KU Leuven
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Katholieke Universiteit Leuven
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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