Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease
Ovarian Cancer PROM Quality of Life

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  1. Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. [ Time Frame: 3 years. ]

Secondary Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with Ovarian Cancer
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916875


Locations
Layout table for location information
Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Danish Cancer Society
AmbuFlex
Investigators
Layout table for investigator information
Principal Investigator: Anette S. Kargo, MD University of Southern Denmark and Vejle Hospital, Denmark
Study Chair: Karina D. Steffensen, MD, PhD Vejle Hospital, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02916875    
Other Study ID Numbers: PROMova
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by Vejle Hospital:
Shared decision Making
Follow-up
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type