NCT03375801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

October 31, 2017

Last Update Submit

July 27, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days after the decision on their radiation treatment has been made

Secondary Outcomes (5)

  • Improvement on the perceived level of shared decision making.

    90 days after the decision on their radiation treatment has been made

  • Improvement on the perceived level of shared decision making.

    90 days after the decision on their radiation treatment has been made

  • Patient knowledge

    directly after the decision on adjuvant RT has been made (<3 days)

  • Decisional conflict

    365 days after the decision on adjuvant RT has been made

  • Prospective process evaluation

    directly after the decision on adjuvant RT has been made (<3 days)

Study Arms (2)

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.

Other: Decision Aid

Interventions

Decision AidOTHER

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

intervention arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Radboud UMC

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MAASTRO-clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

Maastricht University

Maastricht, Limburg, Netherlands

Location

Academisch Medisch Centrum (AMC)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

NKI-AVL

Amsterdam, North Holland, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 32298961DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
first 164 patients will not receive the decision aid, they will only fill out the questionnaires. The next 164 patients will receive the decision aid and will be asked to fill out the same questionnaires.
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Pre- and post intervention study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

December 18, 2017

Study Start

October 1, 2017

Primary Completion

October 30, 2019

Study Completion

July 27, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(5)