Ovarian cancer (OC) treatment is associated with psychological morbidity. We prospectively studied the impact of a brief course of psychological support on self-reported depression, fear of progression (FoP) and quality of life (QOL) in patients (pts) following chemotherapy for primary or recurrent OC.
Pts consented at their first post-chemotherapy appointment and were eligible if they scored from 5-19 on PHQ9 questionnaire. They were randomised 1:1 to Intervention or Control. Intervention comprised 3 standardised 90-minute sessions of psychological support given 6 -12 weeks after chemotherapy. Control was standard of care in which support was provided where indicated; unblinded block randomisation was used for primary or recurrent OC and 3 levels of PHQ9 as stratification factors. Pts completed PHQ9, FoP-Q-SF, EORTC QLQ C30 and OV28 questionnaires up to 2 years. Primary endpoint was change in PHQ9 score at 3 months compared to baseline.
Oct 2015 - Nov 2017: 182 pts were registered; 107 were eligible and randomised; 54 to Intervention and 53 to Control; mean age of 59 yrs; 75 (70%) primary and 32 (30%) relapsed disease; 63 pts completed baseline and 3-month questionnaires and were included in the analysis: 31 control, 32 intervention. At 3 months there was an improvement in the PHQ9 and the Global Health Status/QOL scale for pts in both arms compared to baseline but no significant difference between Intervention and Control. However, there was a significant improvement on FoP-Q-SF scores in the Intervention arm whilst, for pts in the Control arm, FoP-Q-SF scores deteriorated at 3 months (Intervention effect = -5.2, 95%CI (-8.45-1.9) p = 0.003).
Overall, although symptoms of depression improved following completion of chemotherapy for patients in both arms of the study, Fear of Progression did not. This is the first randomised trial of a survivorship intervention in OC and demonstrates that Fear of Progression is a prominent concern for pts but it can be overcome with provision of psychological support immediately after chemotherapy.
Clinical trial identification
UKCRN ID 15363.
Legal entity responsible for the study
Imperial College London.
Imperial College Healthcare Charity, Maggie's Centres.
S. Blagden: Advisor: Ellipses; Director of RNA Guardian Ltd, Ad boards: Clovis, Novartis; Research funding: Nucana plc. R.M. Glasspool: Advisory boards: Clovis, Tesaro, Roche, AstraZeneca; Institution receives research funding: Ignyta, Boehringer Ingelheim, AstraZeneca, Tesaro. S. Nicum: Advisory boards: Roche, Tesaro, Clovis, AstraZeneca; Research funding: AstraZeneca. All other authors have declared no conflicts of interest.