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

Completed

• Conditions: Ovarian Cancer; Quality of Life; PROM

• Registration Number: NCT02916875
• Lead Sponsor: Vejle Hospital

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

Not available

Study Timeline

• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Study Start: 2016-10
• Primary Completion: 2018-12
• Study Completion: 2022-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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

Exclusion Criteria

•Have recurrent disease after first line treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.	3 years.

Secondary Outcome Measures

Name	Time	Method
Quality of life and symptom screening as measured by combined questionnaires EORTC QLQ-C30, EORTC-OV28, and symptom screening questions.	3 years. Every 3 months for two years and every 6 months the third year.

Trial Locations

Locations (1)

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark