Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment.

NCT ID: NCT03375801

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-07-27

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group/pre 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention arm

another 164 patients will receive the decision aid as support for the decision making process with their clinician.

Group Type: EXPERIMENTAL

Decision Aid

Intervention Type: OTHER

This will be an online tool giving evidence based information and explanation on their options.

Interventions

Decision Aid

This will be an online tool giving evidence based information and explanation on their options.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Metastasis
• Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud UMC

Nijmegen, Gelderland, Netherlands

MAASTRO-clinic

Maastricht, Limburg, Netherlands

Maastricht University

Maastricht, Limburg, Netherlands

Academisch Medisch Centrum (AMC)

Amsterdam, North Holland, Netherlands

NKI-AVL

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 32298961 (View on PubMed)

Other Identifiers

M17SDM

Identifier Type: -

Identifier Source: org_study_id