Breast CancerNCT03357744
The Distress-barometer: Face-to-face Interviews or Written Self-report Questionnaires?
An observational study of Breast Cancer, run by KU Leuven.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- distress barometer
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Oct 2016
- How long will I take part?
- 2 Weeks
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants were female breast cancer patients who received their diagnosis about three years before the study.
Who may be able to join
- breast cancer, diagnosed 3 years ago
Who cannot join
- dementia
- no thorough command of Dutch
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- distress barometer
- Keywords
- distress, assessment methods
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distress barometerOther
not applicable, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress agreement between written and oral form of the questionnaire 'Distress Barometer'.
agreement between different assesment methods of distress barometer
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Bert Aertgeerts, KU Leuven
- Investigators
- Marjan van den Akker, PhD, Study chair, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357744
- Sponsor's protocol ID
- Katholieke Universiteit Leuven
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face-to-face Interviews or Written Self-report Questionnaires: The Distress-barometer as a Screening Instrument for Psychosocial Complaints in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03357744
- Acronym / sponsor ID
- Katholieke Universiteit Leuven
- Conditions
- Breast Cancer
- Keywords
- distress, assessment methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Nov 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were female breast cancer patients who received their diagnosis about three years before the study.
Key inclusion criteria (1 listed)
- breast cancer, diagnosed 3 years ago
Key exclusion criteria (2 listed)
- dementia
- no thorough command of Dutch
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 |
|---|---|---|
| distress barometernot applicable, observational study | Other | – |
Primary outcome
Distress agreement between written and oral form of the questionnaire 'Distress Barometer'.
Time frame: 2 weeks
agreement between different assesment methods of distress barometer
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 30 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Marjan van den Akker, PhD study chair
KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by KU Leuven.
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 1 inclusion and 2 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 30 Nov 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?
Distress agreement between written and oral form of the questionnaire 'Distress Barometer'. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2017.