1. OVPSYCH2: A randomized controlled trial of psychological support versus standard of care following chemotherapy for ovarian cancer.
- Author
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Frangou E, Bertelli G, Love S, Mackean MJ, Glasspool RM, Fotopoulou C, Cook A, Nicum S, Lord R, Ferguson M, Roux RL, Martinez M, Butcher C, Hulbert-Williams N, Howells L, and Blagden SP
- Subjects
- Aged, Depression diagnosis, Depression etiology, Depression psychology, Disease Progression, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Recurrence, Local, Ovarian Neoplasms drug therapy, Ovarian Neoplasms psychology, Patient Health Questionnaire statistics & numerical data, Pilot Projects, Prospective Studies, Quality of Life, Standard of Care, Treatment Outcome, Antineoplastic Agents therapeutic use, Cognitive Behavioral Therapy methods, Depression therapy, Fear psychology, Ovarian Neoplasms rehabilitation
- Abstract
Background: Fear of disease progression (FOP) is a rational concern for women with Ovarian Cancer (OC) and depression is also common. To date there have been no randomized trials assessing the impact of psychological intervention on depression and FOP in this patient group., Patients and Methods: Patients with primary or recurrent OC who had recently completed chemotherapy were eligible if they scored between 5 and 19 on the PHQ-9 depression and were randomized 1:1 to Intervention (3 standardized CBT-based sessions in the 6-12 weeks post-chemotherapy) or Control (standard of care). PHQ-9, FOP-Q-SF, EORTC QLQ C30 and OV28 questionnaires were then completed every 3 months for up to 2 years. The primary endpoint was change in PHQ-9 at 3 months. Secondary endpoints were change in other scores at 3 months and all scores at later timepoints., Results: 182 patients registered; 107 were randomized; 54 to Intervention and 53 to Control; mean age 59 years; 75 (70%) had completed chemotherapy for primary and 32 (30%) for relapsed OC and 67 patients completed both baseline and 3-month questionnaires. Improvement in PHQ-9 was observed for patients in both study arms at three months compared to baseline but there was no significant difference in change between Intervention and Control. A significant improvement on FOP-Q-SF scores was seen in the Intervention arm, whereas for those in the Control arm FOP-Q-SF scores deteriorated at 3 months (intervention effect = -4.4 (-7.57, -1.22), p-value = 0.008)., Conclusions: CBT-based psychological support provided after chemotherapy did not significantly alter the spontaneously improving trajectory of depression scores at three months but caused a significant improvement in FOP. Our findings call for the routine implementation of FOP support for ovarian cancer patients., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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