Breast Cancer PatientsVIPNCT01091584
Nurse Intervention Project
A study testing distress thermometer in people with Breast Cancer Patients, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer Patients
- What is being tested?
- distress thermometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Jul 2016
- Phase
- Interventional
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven malignancy of the breast
- Curative treatment
- Dominated the dutch language
- Age > 18 year
Who cannot join
- Previously treated for a malignancy
- Psychiatric problems that adherence this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Assess the (Cost) Effectiveness of the Use of the Distress Thermometer by a Nurse in Addition to Usual Care for Patients Treated With Curative Intent for Breast Cancer.
The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.
- Conditions
- Breast Cancer Patients
- Being tested
- distress thermometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distress thermometerDevice
to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | The intervention is to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse. Receives: Device: distress thermometer |
| control group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subscale quality of life of the questionnaire: EORTC QLQ C30
Subscale quality of life of the questionnaire: EORTC QLQ C30
Measured: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Secondary outcomes (1)
Other subscales
Other subscales:
- HADS : anxiety and depression
- EORTC BR23 : breast cancer specific problems
- SVL: Impact of Event Scale
- ZCL : illness cognition questionnaire with subscales: disease benefits, acceptance and helplessness
- EuroQoL6D,
- Cost diary
Measured: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2013
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P. B. Ottevanger, Dr, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091584
- Sponsor's protocol ID
- CMO: 2009/293
- Acronym
- VIP
- Status last verified
- Nov 2016
- First submitted
- 17 Mar 2010
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ploos van Amstel FK, Prins JB, van der Graaf WT, Peters ME, Ottevanger PB. The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial. BMC Cancer. 2016 Jul 25;16:520. doi: 10.1186/s12885-016-2565-x.
PubMed 27455960
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess the (Cost) Effectiveness of the Use of the Distress Thermometer by a Nurse in Addition to Usual Care for Patients Treated With Curative Intent for Breast Cancer.
- ClinicalTrials.gov ID
- NCT01091584
- Acronym / sponsor ID
- VIP / CMO: 2009/293
- Conditions
- Breast Cancer Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Mar 2010 (estimated)
- 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.
The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Device: distress thermometerThe intervention is to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse. |
| control group | No intervention | –usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven malignancy of the breast
- Curative treatment
- Dominated the dutch language
- Age > 18 year
Key exclusion criteria (2 listed)
- Previously treated for a malignancy
- Psychiatric problems that adherence this study
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 thermometerto apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse | Device | intervention group |
Primary outcome
Subscale quality of life of the questionnaire: EORTC QLQ C30
Time frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Subscale quality of life of the questionnaire: EORTC QLQ C30
1 secondary outcome
Other subscales
Time frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
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 5 Dec 2016.
- Derived from this study: PubMed 27455960Ploos van Amstel FK, Prins JB, van der Graaf WT, Peters ME, Ottevanger PB. The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial. BMC Cancer. 2016 Jul 25;16:520. doi: 10.1186/s12885-016-2565-x.
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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.
P. B. Ottevanger, Dr principal investigator
University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distress thermometer in people with Breast Cancer Patients, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Subscale quality of life of the questionnaire: EORTC QLQ C30 (time frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091584, which also lists 1 linked publication.
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 5 Dec 2016.