OVPSYCH2: A randomised study of psychological support versus standard of care following chemotherapy for ovarian cancer

Abstract

Background: 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. Methods: 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. Results: 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). Conclusions: 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.