Cancer, BreastIMPACTTNCT05573022
Impact of a Patient Decision Aid Intervention
A study testing Pre-consultation electronic patient decision aid and In-consultation paper-based patient decision aid in people with Cancer, Breast and Cancer Colorectal, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer Colorectal
- What is being tested?
- Pre-consultation electronic patient decision aid and In-consultation paper-based patient decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2022to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified breast or colorectal cancer
- Age ≥ 18 years
Who cannot join
- Unable to read Danish
- Not the owner/user of a mobile smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?
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.
Read the 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
- Being tested
- Pre-consultation electronic patient decision aid, In-consultation paper-based patient decision aid
- Keywords
- Shared decision making, Patient decision aids, Patient preferences, Patient engagement
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Patient Preference, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-consultation electronic patient decision aidOther
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 aidOther
This group is introduced to a paper-based version by the clinician in the consultation
| Study group | Role | What they receive |
|---|---|---|
| Arm A1: Breast cancer patients | Experimental | Not described Receives: Other: Pre-consultation electronic patient decision aid |
| Arm B1: Breast cancer patients | Active comparator | Not described Receives: Other: In-consultation paper-based patient decision aid |
| Arm A2: Colorectal cancer patients | Experimental | Not described Receives: Other: Pre-consultation electronic patient decision aid |
| Arm B2: Colorectal cancer patients | Active comparator | Not described Receives: Other: In-consultation paper-based patient decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 3 months
Secondary outcomes (8)
Patient-perceived level of shared decision making (breast and colorectal cancer)
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.
Measured: Within one week after the consultation
Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)
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.
Measured: Within one week after the consultation
Level of patient preparation for decision making (breast and colorectal cancer)
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.
Measured: Within one week after the consultation
Level of decisional conflict (breast and colorectal cancer)
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.
Measured: Before consultation and within one week after the consultation
Degree of control over the decision about medical treatment (breast and colorectal cancer)
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.
Measured: Before the consultation
Consultant-perceived level of shared decision making (breast and colorectal cancer)
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.
Measured: Within one week after the consultation
Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)
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.
Measured: Through study completion, an average of 3 months
Level of involvement of patients in shared decision making (colorectal 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.
Measured: Within one week after the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start15 Nov 2022
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Karina Dahl Steffensen, Study chair, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573022
- Sponsor's protocol ID
- IMPACTT
- Acronym
- IMPACTT
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make data available to others
Publications
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.
PubMed 38475758
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?
- ClinicalTrials.gov ID
- NCT05573022
- Acronym / sponsor ID
- IMPACTT / IMPACTT
- Conditions
- Cancer, Breast, Cancer Colorectal
- Keywords
- Shared decision making, Patient decision aids, Patient preferences, Patient engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically verified breast or colorectal cancer
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Unable to read Danish
- Not the owner/user of a mobile smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-consultation electronic patient decision aidThis 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 | Arm A1: Breast cancer patients, Arm A2: Colorectal cancer patients |
| In-consultation paper-based patient decision aidThis group is introduced to a paper-based version by the clinician in the consultation | Other | Arm B1: Breast cancer patients, Arm B2: Colorectal cancer patients |
Primary outcome
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.
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.
8 secondary outcomes
Patient-perceived level of shared decision making (breast and colorectal cancer)
Time frame: Within one week after the consultation
Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)
Time frame: Within one week after the consultation
Level of patient preparation for decision making (breast and colorectal cancer)
Time frame: Within one week after the consultation
Level of decisional conflict (breast and colorectal cancer)
Time frame: Before consultation and within one week after the consultation
Degree of control over the decision about medical treatment (breast and colorectal cancer)
Time frame: Before the consultation
Consultant-perceived level of shared decision making (breast and colorectal cancer)
Time frame: Within one week after the consultation
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
Level of involvement of patients in shared decision making (colorectal cancer)
Time frame: Within one week after the consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 38475758Knudsen 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.
- Individual participant dataSharing planned: No. There is currently no plan to make data available to others
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Dahl Steffensen study chair
Sygehus Lillebaelt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-consultation electronic patient decision aid and In-consultation paper-based patient decision aid in people with Cancer, Breast and Cancer Colorectal, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of involvement of patients in shared decision making (breast cancer) (time frame: Within one week after the consultation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.