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Spots Global Cancer Trial Database for Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

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Trial Identification

Brief Title: Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

Official Title: Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

Study ID: NCT02916875

Interventions

Study Description

Brief Summary: In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU) program for patients with ovarian cancer. The new FU program argues that there is no effect of routine monitoring, and every patient's FU is now individualized. These changes have caused major concern, especially regarding the omission of routine examinations aimed at detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools and FU plans to support the patients in feeling safe during FU are of vital importance. Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs, symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side effects. 300 patients with ovarian cancer are planned to be enrolled after primary treatment when they enter follow-up program. This is a multi-center study. All participants fill in a questionnaire at baseline and then every 3 months for two years, and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28, and questions on symptoms of relapse. At baseline the questionnaire is extended with demographic issues. The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient satisfaction and the level of shared decision making experienced. All participants are followed for 3 years.

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: Vejle Hospital, Denmark

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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