Breast CancerBRASANCT03375801
Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment.
A study testing Decision Aid in people with Breast Cancer, run by Maastricht University at 5 sites in Netherlands.
Trial summary
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Oct 2017to 27 Jul 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Female
- Doubtful indication of:
- Whole breast irradiation after lumpectomy for DCIS
- Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study)
- Boost dose in case of Breast Conserving Therapy
- Thoracic wall irradiation post mastectomy
Who cannot join
- Metastasis
- Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Academisch Medisch Centrum (AMC)
Amsterdam, North Holland, 1105 AZ
NKI-AVL
Amsterdam, North Holland
MAASTRO-clinic
Maastricht, Limburg, 6229 ET
Maastricht University
Maastricht, Limburg
Radboud UMC
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.
Read the detailed description
Rationale: Guidelines on breast cancer treatment show grey areas for some radiotherapy (RT) indications. In some recommendations the uncertainty is marked and deferred to sharing the final decision on the treatment of choice with the patient. Other recommendations are straightforward, but the multidisciplinary team may decide, based on the latest literature, that different options should be discussed with the patient. In these so called "preference sensitive decisions" there is not one best option. The best option depends on the individual patients' preferences based on neutral and complete information tailored to her own situation. Decision aids support clinicians as well as patients in Shared Decision Making (SDM). Decision aids reduce the patient's decisional conflict after making their decision, increase their knowledge on their illness and the treatment options, and their perceived level of involvement in the decision making process. Although extensive research has been carried out on the effect of decision aids in clinical trials, less is known of the effect of a decision aid in daily clinical practice. The implementation of SDM is challenged by many barriers. The investigators hypothesize that adapting the decision aid to individual patient characteristics may enhance both personalised medicine and SDM.
Objective: To investigate whether SDM using a personalised decision aid, results in improved outcomes of decisional quality, measured by the Decisional Conflict Scale after 3 months and one year, and improved outcomes of the decisional process, measured with the SDMQ9 and collaboRATE directly after the last consultation, compared to the standard clinical practices in breast cancer patients facing a decision on their radiation treatment.
Study design: This is a multicenter clustered , pre- and post-intervention study. Before the intervention 164 patients will be included. After introducing the decision aid, at the beginning of the intervention period, clinicians will be trained in using the decision aid and the other 164 patients will be recruited.
Study population: Breast cancer patients facing a decision in their adjuvant radiation treatment.
Intervention: The intervention group will receive the instructions and the online decision aid.
Main study parameters/endpoints: Primary endpoint: Decisional conflict 3 months after the decision has been made. Secondary endpoint(s): The perceived level of shared decision making, patient knowledge, , and decisional conflict 1 year after decision has been made. A process evaluation will also be perform.
- Conditions
- Breast Cancer
- Being tested
- Decision Aid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
This will be an online tool giving evidence based information and explanation on their options.
| Study group | Role | What they receive |
|---|---|---|
| control group/pre intervention | No intervention | the first 164 patients will receive care as usual and will make the decision together with their clinician without support of the decision aid. They will be asked to fill out the questionnaires. |
| intervention arm | Experimental | another 164 patients will receive the decision aid as support for the decision making process with their clinician. Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
measured with on the decisional conflict scale. Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict).
The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.
Measured: 90 days after the decision on their radiation treatment has been made
Secondary outcomes (5)
Improvement on the perceived level of shared decision making.
measured with the 9-item Shared Decision Making questionnaire (SDM-Q-9,( Kriston 2009)). This contains 9 questions answered on a 6 point likert scale, ranging from 0 ( completely disagree) to 5 ( completely agree). The total score is calculated by: summed score multiplied by 2.2222 transforming to a scale from 0 to 100.
Measured: 90 days after the decision on their radiation treatment has been made
Improvement on the perceived level of shared decision making.
measured with the collaboRATE questionnaire ( Barr 2014), This contains 3 questions answered on a 10 point anchored scale, ranging from 0 ( no effort was made) to 9 ( every effort was made). The total score is calculated by: summed score multiplied by 3.704 transforming to a scale from 0 ( no effort made) to 100 (every effort made).
Measured: 90 days after the decision on their radiation treatment has been made
Patient knowledge
measured with a ( self developed) knowledge test. This contains 11 questions with 3 possible answers ( True, not true and don't know). For every right answered question 1 point, wrong answers -1 and don't know 0 are given resulting in a range from -11 ( all answers wrong) to 11 ( all answers right).
Measured: directly after the decision on adjuvant RT has been made (<3 days)
Decisional conflict
measured with on the decisional conflict scale Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict).
The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.
Measured: 365 days after the decision on adjuvant RT has been made
Prospective process evaluation
how many patients did effectively use the decision aid and how many consultations were needed for the decision to be made. Measured by a log system on the decision aid and by consulting the patients on how many consultations they hade before making the decision.
Measured: directly after the decision on adjuvant RT has been made (<3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Oct 2017
- Primary completion30 Oct 2019
- Study completion27 Jul 2020
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre- and post intervention study.
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375801
- Sponsor's protocol ID
- M17SDM
- Acronym
- BRASA
- Status last verified
- Jul 2020
- First submitted
- 31 Oct 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raphael DB, Russell NS, Immink JM, Westhoff PG, Stenfert Kroese MC, Stam MR, van Maurik LM, van den Bongard HJGD, Maduro JH, Sattler MGA, van der Weijden T, Boersma LJ. Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty? Breast. 2020 Jun;51:105-113. doi: 10.1016/j.breast.2020.04.001. Epub 2020 Apr 6.
PubMed 32298961
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
- ClinicalTrials.gov ID
- NCT03375801
- Acronym / sponsor ID
- BRASA / M17SDM
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 18 Dec 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.
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.
Detailed description
Rationale: Guidelines on breast cancer treatment show grey areas for some radiotherapy (RT) indications. In some recommendations the uncertainty is marked and deferred to sharing the final decision on the treatment of choice with the patient. Other recommendations are straightforward, but the multidisciplinary team may decide, based on the latest literature, that different options should be discussed with the patient. In these so called "preference sensitive decisions" there is not one best option. The best option depends on the individual patients' preferences based on neutral and complete information tailored to her own situation. Decision aids support clinicians as well as patients in Shared Decision Making (SDM). Decision aids reduce the patient's decisional conflict after making their decision, increase their knowledge on their illness and the treatment options, and their perceived level of involvement in the decision making process. Although extensive research has been carried out on the effect of decision aids in clinical trials, less is known of the effect of a decision aid in daily clinical practice. The implementation of SDM is challenged by many barriers. The investigators hypothesize that adapting the decision aid to individual patient characteristics may enhance both personalised medicine and SDM.
Objective: To investigate whether SDM using a personalised decision aid, results in improved outcomes of decisional quality, measured by the Decisional Conflict Scale after 3 months and one year, and improved outcomes of the decisional process, measured with the SDMQ9 and collaboRATE directly after the last consultation, compared to the standard clinical practices in breast cancer patients facing a decision on their radiation treatment.
Study design: This is a multicenter clustered , pre- and post-intervention study. Before the intervention 164 patients will be included. After introducing the decision aid, at the beginning of the intervention period, clinicians will be trained in using the decision aid and the other 164 patients will be recruited.
Study population: Breast cancer patients facing a decision in their adjuvant radiation treatment.
Intervention: The intervention group will receive the instructions and the online decision aid.
Main study parameters/endpoints: Primary endpoint: Decisional conflict 3 months after the decision has been made. Secondary endpoint(s): The perceived level of shared decision making, patient knowledge, , and decisional conflict 1 year after decision has been made. A process evaluation will also be perform.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre- and post intervention study.
| Arm | Type | Receives |
|---|---|---|
| control group/pre intervention | No intervention | –the first 164 patients will receive care as usual and will make the decision together with their clinician without support of the decision aid. They will be asked to fill out the questionnaires. |
| intervention arm | Experimental | Other: Decision Aidanother 164 patients will receive the decision aid as support for the decision making process with their clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Female
- Doubtful indication of:
Key exclusion criteria (2 listed)
- Metastasis
- Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.
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 |
|---|---|---|
| Decision AidThis will be an online tool giving evidence based information and explanation on their options. | Other | intervention arm |
Primary outcome
Decisional conflict
Time frame: 90 days after the decision on their radiation treatment has been made
measured with on the decisional conflict scale. Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict). The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.
5 secondary outcomes
Improvement on the perceived level of shared decision making.
Time frame: 90 days after the decision on their radiation treatment has been made
Improvement on the perceived level of shared decision making.
Time frame: 90 days after the decision on their radiation treatment has been made
Patient knowledge
Time frame: directly after the decision on adjuvant RT has been made (<3 days)
Decisional conflict
Time frame: 365 days after the decision on adjuvant RT has been made
Prospective process evaluation
Time frame: directly after the decision on adjuvant RT has been made (<3 days)
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 28 Jul 2020.
- Derived from this study: PubMed 32298961Raphael DB, Russell NS, Immink JM, Westhoff PG, Stenfert Kroese MC, Stam MR, van Maurik LM, van den Bongard HJGD, Maduro JH, Sattler MGA, van der Weijden T, Boersma LJ. Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty? Breast. 2020 Jun;51:105-113. doi: 10.1016/j.breast.2020.04.001. Epub 2020 Apr 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Breast Cancer, run by Maastricht University at 5 sites 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 7 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Decisional conflict (time frame: 90 days after the decision on their radiation treatment has been made). 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 NCT03375801, 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 28 Jul 2020.