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Spots Global Cancer Trial Database for Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125

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Trial Identification

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

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

Study ID: NCT03004391

Conditions

Ovarian Cancer

Interventions

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Department of Oncology, Vejle Hospital, Vejle, , Denmark

Contact Details

Name: Anette S. Kargo, MD

Affiliation: University of Southern Denmark and Vejle Hospital, Denmark

Role: PRINCIPAL_INVESTIGATOR

Name: Karina D. Steffensen, MD, PhD

Affiliation: University of Southern Denmark and Vejle Hospital, Denmark

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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