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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer PROM Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
* Can receive active anti-cancer treatment such as maintenance bevacizumab