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

NCT02916875 | Completed

• 1 other identifier: PROMova
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; PROM; Quality of Life

Keywords

Shared decision Making; Follow-up

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with Ovarian Cancer

You may qualify if:

• 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

You may not qualify if:

• Have recurrent disease after first line treatment.

Sponsors & Collaborators

• Vejle Hospital: lead
• Danish Cancer Society: collaborator
• AmbuFlex: collaborator

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32586892 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Anette S. Kargo, MD

  University of Southern Denmark and Vejle Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Karina D. Steffensen, MD, PhD

  Vejle Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

DK (1)