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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916875
• Other study ID #: PROMova
• Status: Completed
• Start date: October 2016
• Est. completion date: January 2022

Study information

• Verified date: March 2022
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: January 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• PROM
• Quality of Life

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Vejle Hospital	AmbuFlex, Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.		3 years.
Secondary	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.