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Impact of a Patient Decision Aid Intervention

NCT05573022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-11-17

No results posted yet for this study

Summary

Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.

Conditions

  • Cancer, Breast
  • Cancer Colorectal

Interventions

OTHER

Pre-consultation electronic patient decision aid

This group is invited to access an electronic version before the consultation. The group of colorectal cancer patients is also introduced to a paper-based version by the clinician in the consultation.

OTHER

In-consultation paper-based patient decision aid

This group is introduced to a paper-based version by the clinician in the consultation

Sponsors & Collaborators

  • The Ottawa Hospital Research Institute

    collaborator UNKNOWN

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Karina Dahl Steffensen · Sygehus Lillebaelt

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573022 on ClinicalTrials.gov