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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03004391
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : October 1, 2019
Danish Cancer Society
Design School Kolding
Information provided by (Responsible Party):
Vejle Hospital

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
Ovarian Cancer

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. Patient uncertainty as to routine measurement of CA125 is measured by combined questionnaires CollaboRATE and Decisional Conflict Scale. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Patient satisfaction as to choice made measured by questionnaire Decision Regret Scale [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with ovarian cancer

Inclusion Criteria:

  • Patients >18 years of age
  • Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer
  • Have completed their first line treatment, with complete remission.
  • Manage to read and speak Danish

Exclusion Criteria:

  • Have recurrent disease after first line treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03004391

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Contact: Anette S. Kargo, MD +45 7940 5292
Contact: Karina D. Steffensen, MD, PhD

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Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Danish Cancer Society
Design School Kolding
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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

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Responsible Party: Vejle Hospital Identifier: NCT03004391     History of Changes
Other Study ID Numbers: CA125-DA
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by Vejle Hospital:
Shared decision making
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type