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

• ClinicalTrials.gov Identifier: NCT02916875
• Recruitment Status: Active, not recruiting
• First Posted: September 28, 2016
• Last Update Posted: January 22, 2020
• Sponsor: Vejle Hospital
• Collaborators: Danish Cancer Society; AmbuFlex
• Information provided by (Responsible Party): Vejle Hospital

Tracking Information

• First Submitted Date: September 23, 2016
• First Posted Date: September 28, 2016
• Last Update Posted Date: January 22, 2020
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 15, 2016): Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. [ Time Frame: 3 years. ]
• Original Primary Outcome Measures (submitted: September 27, 2016): 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. ]
• Current Secondary Outcome Measures (submitted: November 15, 2016): 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. ]
• Original Secondary Outcome Measures (submitted: September 27, 2016): Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. [ Time Frame: 3 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patient diagnosed with Ovarian Cancer

Condition

• Ovarian Cancer
• PROM
• Quality of Life

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Kargo AS, Coulter A, Lindemann K, Jensen PT, Hjøllund 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 27, 2016): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2021
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02916875
• Other Study ID Numbers: PROMova
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Vejle Hospital
• Study Sponsor: Vejle Hospital

Collaborators

• Danish Cancer Society
• AmbuFlex

Investigators

• Principal Investigator: Anette S. Kargo, MD; University of Southern Denmark and Vejle Hospital, Denmark
• Study Chair: Karina D. Steffensen, MD, PhD; Vejle Hospital, Denmark

• PRS Account: Vejle Hospital
• Verification Date: January 2020