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Completed

NCT Number: NCT05573022

Impact of a Patient Decision Aid Intervention

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillebaelt Hospital

Vejle, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

In-consultation paper-based patient decision aid

Other

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

Primary outcomes

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

    Time frame: Within one week after the consultation

    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.

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

    Time frame: Through study completion, an average of 3 months

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

Secondary outcomes

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

    Time frame: Within one week after the consultation

    9-item Shared Decision Making Questionnaire (SDM-Q-9) that measures the extent to which patients are involved in the process of decision-making from the perspective of the patient. Scores range from 1 to 6 on each question. The total score range is thus 9-54 with 54 as the best score indicating higher involvement.

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

    Time frame: Within one week after the consultation

    3-item questionnaire (CollaboRATE) with patient-reported measures of the perception of being informed and involved in decision making. Each item is scored on a 0 to 9 scale on a 10-point Likert scale, a higher score indicates a better experience.

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

    Time frame: Within one week after the consultation

    10-item questionnaire (Preparation for Decision Making Scale) with patient-reported measures of how useful the decision aid / decision support intervention is in preparing the patient for the consultation. The scale is from 1 (not at all useful) to 5 (very useful). Higher scores indicate greater preparation.

  4. Level of decisional conflict (breast and colorectal cancer)

    Time frame: Before consultation and within one week after the consultation

    16-item questionnaire (Decisional conflict scale) with patient-reported measures of uncertainty and decisional conflict. Each item is rated on a 5-point scale, and total scores are calculated by summing the raw scores of all items and presenting them on a scale of 0-100, with higher scores indicating greater decision conflict. Scores greater than 25 indicate clinically important decisional conflict.

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

    Time frame: Before the consultation

    1-item questionnaire (Control Preference Scale) with a patient-reported measure of the degree of control that the patient wants to assume when decisions are being made about medical treatment. Answers range from Fully active role, Semiactive role, Collaborative role, Semipassive role and Fully passive role.

  6. Consultant-perceived level of shared decision making (breast and colorectal cancer)

    Time frame: Within one week after the consultation

    9-item Shared Decision Making Questionnaire (SDM-Q-doc) that measures the extent to which patients are involved in the process of decision-making from the perspective of the consultant. The items are scored from 0 to 5 on a six-point Likert scale ranging from "completely disagree" (0) to "completely agree" (5). A linear transformation of item score sum yields a transformed score (0-100), with higher values indicating more shared decision making.

  7. Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)

    Time frame: Through study completion, an average of 3 months

    Measuring shared decision making by assessing recordings of encounters from clinical settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.

  8. Level of involvement of patients in shared decision making (colorectal cancer)

    Time frame: Within one week after the consultation

    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.

Other outcomes

  1. Consultation length measured in minutes

    Time frame: Through study completion, an average of 3 months

    Length of consultation in minutes

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Ottawa Hospital Research Institute

Registry information

Official study title

Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?

Acronym: IMPACTT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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