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Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125

NCT03004391 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-02-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Design School Kolding

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Anette S. Kargo, MD · University of Southern Denmark and Vejle Hospital, Denmark

  • Karina D. Steffensen, MD, PhD · University of Southern Denmark and Vejle Hospital, Denmark

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004391 on ClinicalTrials.gov