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

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ClinicalTrials.gov Identifier: NCT02916875
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : January 22, 2020
Sponsor:
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. ]
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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