Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
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| ClinicalTrials.gov Identifier: NCT02916875 |
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Recruitment Status :
Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : January 22, 2020
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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 |
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| Ovarian Cancer PROM Quality of Life |
| 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 |
- Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. [ Time Frame: 3 years. ]
- 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. ]
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| 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 |
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.
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
| Denmark | |
| Department of Oncology, Vejle Hospital | |
| Vejle, Denmark | |
| Principal Investigator: | Anette S. Kargo, MD | University of Southern Denmark and Vejle Hospital, Denmark | |
| Study Chair: | Karina D. Steffensen, MD, PhD | Vejle Hospital, Denmark |
| 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 |
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Shared decision Making Follow-up |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |