Investigating harms of testing for ovarian cancer - psychological outcomes and cancer conversion rates in women with symptoms of ovarian cancer: A cohort study embedded in the multicentre ROCkeTS prospective diagnostic study

Abstract

Objective: To investigate psychological correlates in women referred with suspected ovarian cancer via the fast-track pathway, explore how anxiety and distress levels change at 12 months post-testing, and report cancer conversion rates by age and referral pathway.

Design: Single-arm prospective cohort study.

Setting: Multicentre. Secondary care including outpatient clinics and emergency admissions.

Population: A cohort of 2596 newly presenting symptomatic women with a raised CA125 level, abnormal imaging or both.

Methods: Women completed anxiety and distress questionnaires at recruitment and at 12 months for those who had not undergone surgery or a biopsy within 3 months of recruitment.

Main outcome measures: Anxiety and distress levels measured using a six-item short form of the State-Trait Anxiety Inventory (STAI-6) and the Impact of Event Scale - Revised (IES-r) questionnaire. Ovarian cancer (OC) conversion rates by age, menopausal status and referral pathway.

Results: Overall, 1355/2596 (52.1%) and 1781/2596 (68.6%) experienced moderate-to-severe distress and anxiety, respectively, at recruitment. Younger age and emergency presentations had higher distress levels. The clinical category for anxiety and distress remained unchanged/worsened in 76% of respondents at 12 months, despite a non-cancer diagnosis. The OC rates by age were 1.6% (95% CI 0.5%-5.9%) for age <40 years and 10.9% (95% CI 8.7%-13.6%) for age ≥40 years. In women referred through fast-track pathways, 3.3% (95% CI 1.9%-5.7%) of pre- and 18.5% (95% CI 16.1%-21.0%) of postmenopausal women were diagnosed with OC.

Conclusions: Women undergoing diagnostic testing display severe anxiety and distress. Younger women are especially vulnerable and should be targeted for support. Women under the age of 40 years have low conversion rates and we advocate reducing testing in this group to reduce the harms of testing.

Keywords: anxiety; conversion rates; depression; diagnosis; fast‐track pathways; ovarian cancer.

Figure 1

Heat map to illustrate change in STAI-6 scores at recruitment and at the 12 month follow-up among 467 respondents. Red dots represent subjects in whom distress levels became more severe by three categories, yellow in those in whom clinical anxiety or distress category remained unchanged and dark green in those in whom the anxiety or distress levels improved by three categories.

Figure 2

Heat map to illustrate change in IES-r scores at recruitment and at the 12 month follow-up among 473 respondents. Red dots represent subjects in whom distress levels became more severe by three categories, yellow in those in whom clinical anxiety or distress category remained unchanged and dark green in those in whom the anxiety or distress levels improved by three categories.