Impact of a Patient Decision Aid Intervention

NCT05573022 | Completed

• 1 other identifier: IMPACTT
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer Colorectal

Keywords

Shared decision making; Patient decision aids; Patient preferences; Patient engagement

Outcome Measures

Primary Outcomes (2)

• Level of involvement of patients in shared decision making (breast cancer)

  4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.

  Within one week after the consultation

• Observed level of patient involvement in decision making according to the OPTION5 tool (colorectal cancer)

  settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.

  Through study completion, an average of 3 months

Secondary Outcomes (8)

• Patient-perceived level of shared decision making (breast and colorectal cancer)

  Within one week after the consultation

• Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)

  Within one week after the consultation

• Level of patient preparation for decision making (breast and colorectal cancer)

  Within one week after the consultation

• Level of decisional conflict (breast and colorectal cancer)

  Before consultation and within one week after the consultation

• Degree of control over the decision about medical treatment (breast and colorectal cancer)

  Before the consultation

Other Outcomes (1)

• Consultation length measured in minutes

  Through study completion, an average of 3 months

Study Arms (4)

Arm A1: Breast cancer patients

EXPERIMENTAL

Other: Pre-consultation electronic patient decision aid

Arm B1: Breast cancer patients

ACTIVE COMPARATOR

Other: In-consultation paper-based patient decision aid

Arm A2: Colorectal cancer patients

EXPERIMENTAL

Other: Pre-consultation electronic patient decision aid

Arm B2: Colorectal cancer patients

ACTIVE COMPARATOR

Other: In-consultation paper-based patient decision aid

Interventions

Pre-consultation electronic patient decision aid 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 A1: Breast cancer patients; Arm A2: Colorectal cancer patients

In-consultation paper-based patient decision aid OTHER

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

Arm B1: Breast cancer patients; Arm B2: Colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead
• The Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Lillebaelt Hospital

Vejle, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38475758 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Patient Preference; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Study Officials

• Karina Dahl Steffensen

  Sygehus Lillebaelt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a randomised, controlled trial, in which patients are allocated to either a digital pre-consultation patient decision aid or a paper-based in-consultation patient decision aid. A total estimate of 204 patients with breast and 70 patients with colorectal cancer are included in the study including 10% to compensate for missing data and dropouts.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 10, 2022
• Study Start: November 15, 2022
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)