Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125
Study Details
Study Description
Brief Summary
In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU) program for ovarian cancer patients. The new FU program argues that there is no effect of routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish routine measurement of CA 125 to be part of the follow-up program.
Shared Decision Making (SDM) can help health professionals develop a more individualized care plan in collaboration with the patient, as stated in the revised national FU program. Due to the complexity and challenges within ovarian cancer care, this is an evident area of focus.
SDM is defined as an approach in which the clinician and patient go through all phases of the decision-making process together and share the preference for treatment and reach an agreement on treatment choice. Clinicians have information about disease, tests and treatments, whereas patients hold information about their life circumstances, goals of life, and preferences for healthcare. SDM thereby offers a way of individualizing recommendations, according to patients' special needs and preferences. SDM has potential to give the patients a higher quality of healthcare by putting the patient in the center of care.
Decision aids (DA) are tools that can provide information and systematically describe the advantages and disadvantages of a specific intervention or monitoring, which can help patients become involved in decision making. Using evidence-based DA leads to improvement in knowledge, better understanding of screening, prevention and treatment options, and more accurate perception of risks for the patients.
All participants fill in a demographic and Decisional Conflict Scale questionnaire at baseline. After having been presented with the decision aid and made a choice as to CA125, the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire dealing with confidence as to the choice made and the level of shared decision making experienced. Six months later the Decision Regret Scale questionnaire is to be completed to reveal any regrets in relation to the CA125 decision.
For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible for this study will be asked for their opinion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Patient uncertainty as to routine measurement of CA125 is measured by combined questionnaires CollaboRATE and Decisional Conflict Scale. [6 months]
Secondary Outcome Measures
- Patient satisfaction as to choice made measured by questionnaire Decision Regret Scale [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients >18 years of age
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Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer
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Have completed their first line treatment, with complete remission.
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Manage to read and speak Danish
Exclusion Criteria:
- Have recurrent disease after first line treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Oncology, Vejle Hospital | Vejle | Denmark |
Sponsors and Collaborators
- Vejle Hospital
- Danish Cancer Society
- Design School Kolding
Investigators
- Principal Investigator: Anette S. Kargo, MD, University of Southern Denmark and Vejle Hospital, Denmark
- Study Director: Karina D. Steffensen, MD, PhD, University of Southern Denmark and Vejle Hospital, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CA125-DA