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OpenTrials
Completed

NCT Number: NCT02916875

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

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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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms PROM Quality of Life Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Oncology, Vejle Hospital

Vejle, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.

    Time frame: 3 years.

Secondary outcomes

  1. Quality of life and symptom screening as measured by combined questionnaires EORTC QLQ-C30, EORTC-OV28, and symptom screening questions.

    Time frame: 3 years. Every 3 months for two years and every 6 months the third year.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • AmbuFlex
  • Danish Cancer Society

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2022
First posted
Sep 28, 2016
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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