Impact of a Patient Decision Aid Intervention

NCT ID: NCT05573022

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2025-10-10

Brief 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.

Detailed Description

A cancer diagnosis is life-changing and followed by complex decisions about treatment options. Often the decision about which treatment to choose is based on risks and benefits, although the benefit-harm ratios are unknown. In these situations, a patient decision aid can be helpful in explaining the options, clarifying the patient's preferences and acting as an adjunct to the clinician's counselling, supporting the patient in complex decisions about their diagnosis.

Studies evaluating patient decision 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. There is a lack of evidence of the impact of patient decison aids used pre-consultation versus in-consultation, as 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 a digital 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 level as well as an observed level of shared decision making (SDM).

A secondary analysis of the data collected in the study will form the basis of a study testing the convergent validity of the patient-reported measures by comparing them to the observed level of patient involvement. During the last decade, the strong move towards increased SDM has led to development of several measurement scales, and there is a demand for convergent validity studies, as there is no gold standard to evaluate SDM behaviors. Previous validity studies have various shortcomings.

Conditions

Cancer, Breast; Cancer Colorectal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm A1: Breast cancer patients

Group Type: EXPERIMENTAL

Pre-consultation electronic patient decision aid

Intervention Type: OTHER

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.

Arm B1: Breast cancer patients

Group Type: ACTIVE_COMPARATOR

In-consultation paper-based patient decision aid

Intervention Type: OTHER

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

Arm A2: Colorectal cancer patients

Group Type: EXPERIMENTAL

Pre-consultation electronic patient decision aid

Intervention Type: OTHER

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.

Arm B2: Colorectal cancer patients

Group Type: ACTIVE_COMPARATOR

In-consultation paper-based patient decision aid

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

In-consultation paper-based patient decision aid

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Histologically verified breast or colorectal cancer
• Age ≥ 18 years

Exclusion Criteria

• Unable to read Danish
• Not the owner/user of a mobile smartphone

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

Sponsors

The Ottawa Hospital Research Institute

UNKNOWN

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karina Dahl Steffensen

Role: STUDY_CHAIR

Sygehus Lillebaelt

Locations

Lillebaelt Hospital

Vejle, , Denmark

Countries

Denmark

References

Knudsen BM, Sondergaard SR, Stacey D, Steffensen KD. Impact of timing and format of patient decision aids for breast cancer patients on their involvement in and preparedness for decision making - the IMPACTT randomised controlled trial protocol. BMC Cancer. 2024 Mar 12;24(1):336. doi: 10.1186/s12885-024-12086-z.

Reference Type: DERIVED

PMID: 38475758 (View on PubMed)

Other Identifiers

IMPACTT

Identifier Type: -

Identifier Source: org_study_id