Ovarian CancerNCT02916875
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
An observational study of Ovarian Cancer and PROM, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, PROM, Quality of Life
- How many people
- 223 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with Ovarian Cancer
Who may be able to join
- 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
Who cannot join
- •Have recurrent disease after first line treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.
Measured: 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.
Measured: 3 years. Every 3 months for two years and every 6 months the third year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, AmbuFlex
- Responsible party
- Sponsor
- Investigators
- Anette S. Kargo, MD, Principal investigator, University of Southern Denmark and Vejle Hospital, DenmarkKarina D. Steffensen, MD, PhD, Study chair, Vejle Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916875
- Sponsor's protocol ID
- PROMova
- Status last verified
- Mar 2022
- First submitted
- 23 Sep 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32586892
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making
- ClinicalTrials.gov ID
- NCT02916875
- Acronym / sponsor ID
- PROMova
- Conditions
- Ovarian Cancer, PROM, Quality of Life
- Keywords
- Shared decision Making, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, AmbuFlex
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with Ovarian Cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- •Have recurrent disease after first line treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience.
Time frame: 3 years.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 32586892Kargo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette S. Kargo, MD principal investigator
University of Southern Denmark and Vejle Hospital, Denmark
Karina D. Steffensen, MD, PhD study chair
Vejle Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and PROM, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. (time frame: 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.