Clinical trial NCT05573022: Impact of a Patient Decision Aid Intervention
Official title: Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Cancer Colorectal
Keywords: Shared decision making
Patient decision aids
Patient preferences
Patient engagement
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital Research Institute
First posted: 2022-10-10
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Level of involvement of patients in shared decision making (breast cancer)
timeFrame: Within one week after the consultation
measure: Observed level of patient involvement in decision making according to the OPTION5 tool (colorectal cancer)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Patient-perceived level of shared decision making (breast and colorectal cancer)
timeFrame: Within one week after the consultation
measure: Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)
timeFrame: Within one week after the consultation
measure: Level of patient preparation for decision making (breast and colorectal cancer)
timeFrame: Within one week after the consultation
measure: Level of decisional conflict (breast and colorectal cancer)
timeFrame: Before consultation and within one week after the consultation
measure: Degree of control over the decision about medical treatment (breast and colorectal cancer)
timeFrame: Before the consultation
measure: Consultant-perceived level of shared decision making (breast and colorectal cancer)
timeFrame: Within one week after the consultation
measure: Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)
timeFrame: Through study completion, an average of 3 months
measure: Level of involvement of patients in shared decision making (colorectal cancer)
timeFrame: Within one week after the consultation
Other outcomes:
measure: Consultation length measured in minutes
timeFrame: Through study completion, an average of 3 months
Locations:
city: Vejle
country: Denmark
facility: Lillebaelt Hospital
Study officials:
affiliation: Sygehus Lillebaelt
name: Karina Dahl Steffensen
role: STUDY_CHAIR
References: