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

NCT02916875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2022-03-11

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • AmbuFlex

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Anette S. Kargo, MD · University of Southern Denmark and Vejle Hospital, Denmark

  • Karina D. Steffensen, MD, PhD · Vejle Hospital, Denmark

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-12-31
Completion
2022-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916875 on ClinicalTrials.gov