Clinical trial NCT02916875: Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
Official title: Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
PROM
Quality of Life
Keywords: Shared decision Making
Follow-up
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: AmbuFlex
First posted: 2016-09-28
Enrollment: 223
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with Ovarian Cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.
timeFrame: 3 years.
Secondary outcomes:
measure: Quality of life and symptom screening as measured by combined questionnaires EORTC QLQ-C30, EORTC-OV28, and symptom screening questions.
timeFrame: 3 years. Every 3 months for two years and every 6 months the third year.
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: University of Southern Denmark and Vejle Hospital, Denmark
name: Anette S. Kargo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vejle Hospital, Denmark
name: Karina D. Steffensen, MD, PhD
role: STUDY_CHAIR
References:
citation: Kargo AS, Coulter A, Lindemann K, Jensen PT, Hjollund NH, Mosgaard BJ, Steffensen KD. Use of PROM during follow-up of patients with ovarian cancer: the PROMova study protocol. Int J Gynecol Cancer. 2020 Sep;30(9):1444-1449. doi: 10.1136/ijgc-2020-001528. Epub 2020 Jun 24.