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Trial Title:
Impact of a Patient Decision Aid Intervention
NCT ID:
NCT05573022
Condition:
Cancer, Breast
Cancer Colorectal
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Shared decision making
Patient decision aids
Patient preferences
Patient engagement
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Pre-consultation electronic patient decision aid
Description:
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 group label:
Arm A1: Breast cancer patients
Arm group label:
Arm A2: Colorectal cancer patients
Intervention type:
Other
Intervention name:
In-consultation paper-based patient decision aid
Description:
This group is introduced to a paper-based version by the clinician in the consultation
Arm group label:
Arm B1: Breast cancer patients
Arm group label:
Arm B2: Colorectal cancer patients
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lillebaelt Hospital
Address:
City:
Vejle
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Bettina Mølri Knudsen
Phone:
+4524994549
Email:
bettina.knudsen@rsyd.dk
Start date:
November 15, 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Vejle Hospital
Agency class:
Other
Collaborator:
Agency:
The Ottawa Hospital Research Institute
Agency class:
Other
Source:
Vejle Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05573022
