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dc.contributor.authorFrangou, E
dc.contributor.authorBertelli, G
dc.contributor.authorLove, S
dc.contributor.authorMackean, MJ
dc.contributor.authorGlasspool, RM
dc.contributor.authorFotopoulou, C
dc.contributor.authorCook, A
dc.contributor.authorNicum, S
dc.contributor.authorLord, R
dc.contributor.authorFerguson, M
dc.contributor.authorRoux, RL
dc.contributor.authorMartinez, M
dc.contributor.authorButcher, C
dc.contributor.authorHulbert-Williams, NJ
dc.contributor.authorHowells, L
dc.contributor.authorBlagden, SP
dc.date.accessioned2021-06-17T10:13:10Z
dc.date.available2021-06-17T10:13:10Z
dc.date.issued2021-05-29
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/624969/OvPsych2_manuscript_clean_final.pdf?sequence=4
dc.identifier.citationFrangou, E., Bertelli, G., Love, S., Maclean, M. J., Glasspool, R. M., Fotopoulou, C., ... Blagden, S. P. (2021). OVPYSCH2: A randomized controlled trial of psychological support versus standard of care following chemotherapy for ovarian cancer. Gynecologic Oncology, 162(2), 431-439. https://doi.org/10.1016/j.ygyno.2021.05.024en_US
dc.identifier.issn0090-8258
dc.identifier.doi10.1016/j.ygyno.2021.05.024
dc.identifier.urihttp://hdl.handle.net/10034/624969
dc.description.abstractBackground: 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.en_US
dc.publisherElsevieren_US
dc.relation.urlhttps://www.sciencedirect.com/science/article/pii/S0090825821004303en_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.subjectovarian canceren_US
dc.subjectquality of lifeen_US
dc.subjectclinical trialen_US
dc.subjectfear of relapseen_US
dc.subjectfear of progressionen_US
dc.titleOVPSYCH2: A randomized controlled trial of psychological support versus standard of care following chemotherapy for ovarian canceren_US
dc.typeArticleen_US
dc.contributor.departmentUniversity of Oxford; University College London; Sussex Cancer Centre; Edinburgh Cancer Centre; Beatson Cancer Center; Ovarian Cancer Action Research Centre; Gloucester Oncology Centre; Churchill Hospital; Clatterbridge Cancer Centre; Ninewells Hospital; University of Chester; Maggie's Centresen_US
dc.identifier.journalGynecologic Oncologyen_US
or.grant.openaccessYesen_US
rioxxterms.funderImperial Health NHS Charity; Ovarian Cancer Action; NIHRen_US
rioxxterms.identifier.projectN/Aen_US
rioxxterms.versionAMen_US
rioxxterms.versionofrecord10.1016/j.ygyno.2021.05.024
rioxxterms.licenseref.startdate2022-05-29
dcterms.dateAccepted2021-05-22
rioxxterms.publicationdate2021-05-29
dc.date.deposited2021-06-17en_US
dc.indentifier.issn0090-8258en_US


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