Prevention of ovarian cancer Cancer Malignant neoplasm of ovary
Conditions
Interventions
Potential participants who have met the study's inclusion/exclusion criteria and who have expressed interest in the study after receiving a flyer from their GP practice will contact the research team
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged =18 years
Exclusion criteria
Exclusion criteria: 1. Past history of tubal cancer/ovarian cancer/primary peritoneal cancer 2. Personal history of genetic testing for ovarian cancer predisposing genes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability and uptake of the study: 1. Acceptability measured by responses to the decision aid questions and overall score (prior to consent) 2. Uptake measured as number of individuals who express interest in participating in the study (by post/email/telephone) who sign consent form 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Use of helpline, measured by the proportion of individuals using the helpline during the study and by the helpline evaluation questionnaire 2. Risk perception and cancer worry, measured using cancer risk perception and ovarian cancer worry scale questionnaires at baseline, 7 days post results, 3 and 6 months post results for participating individuals (consent form 1), and at study exit for those declining participation (sign consent form 2) 3. Psychological health and quality of life, measured using HADS and EQ5D-5L at baseline, 7 days, 3 and 6 months post results for participating individuals (consent form 1), IES (Impact of Events Scale) used at 7 days, 3 months and 6 months post results for participating individuals, and measured using HADS and EQ5D-5L questionnaires at study exit for those declining participation (consent form 2) 4. Usefulness of decision aid, measured using decision aid evaluation questionnaire post recruitment for participating individuals (consent 1) and at study exit for those declining participation (consent 2) 5. Stratification of ovarian cancer risk category: individuals stratified as high/intermediate/low risk by risk prediction algorithm (post panel genetic test results) 6. Uptake of risk management options, measured as the number of individuals who are intermediate/high risk who accept screening/risk reducing surgery post risk prediction algorithm stratification 7. Satisfaction/regret, measured using decision regret scale questionnaire 3 months post results for participating individuals (consent 1), and using decision regret scale questionnaire at study exit for those declining participation (consent form 2) 8. Follow-up completion rate, measured at study end as the number of individuals who after consenting to participate in the study (consent 1), have the panel genetic test and receive the ovarian cancer test result. The proportion of completed and returned questionnaires is also measured | — |
Countries
England, United Kingdom
Contacts
Public ContactFaiza Gaba
Outcome results
None listed