protocolSection identificationModule nctId: NCT06298877, orgStudyIdInfo id: 2023-04696-01, briefTitle: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer, acronym: FOLERO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2029-03-28, completionDateStruct date: 2029-03-28, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sahar Salehi, class: OTHER, descriptionModule briefSummary: Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \>75 years. Despite these circumstances guidelines on patient-selection are lacking.Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment., conditionsModule conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Frailty and Quality of Life evaluation, outcomesModule primaryOutcomes measure: Overall Survival, secondaryOutcomes measure: 1-year mortality, secondaryOutcomes measure: Health related quality of life (HRQoL) (QLQ-C30), secondaryOutcomes measure: Health related quality of life (HRQoL) (QLQ-OV28), secondaryOutcomes measure: Health related quality of life (HRQoL) (QLQ-ELD14), secondaryOutcomes measure: Health related quality of life (HRQoL) (EQ-5D-5L), secondaryOutcomes measure: Low anterior resection syndrome (LARS), secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Readmissions, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Extent of surgery vs survival, secondaryOutcomes measure: Sarcopenia vs post-operative outcome, secondaryOutcomes measure: Standard regimen of adjuvant chemotherapy, secondaryOutcomes measure: Time interval to adjuvant chemotherapy, secondaryOutcomes measure: Total number of hospital days and readmissions within90 days after index surgery, secondaryOutcomes measure: Health economics, secondaryOutcomes measure: Recurrence or progression free survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, state: Solna, zip: 171 76, country: Sweden, contacts name: Sahar Salehi, MD, Ass Prof, role: CONTACT, email: sahar.salehi@regionstockholm.se, contacts name: Daniel Hunde, MD, role: CONTACT, email: daniel.hunde@regionstockholm.se, contacts name: Daniel Hunde, MD, role: SUB_INVESTIGATOR, contacts name: Sahar Salehi, MD, Ass Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Sahlgrenska University Hospital and Sahlgrenska Academy, status: NOT_YET_RECRUITING, city: Gothenburg, zip: 41685, country: Sweden, contacts name: Pernilla Dahm-Kähler, MD, Prof., role: CONTACT, phone: 0313434216, email: pernilla.dahm-kahler@gu.se, contacts name: Pernilla Dahm-Kähler, MD, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Charlotte Palmqvist, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Linköping University Hospital, status: RECRUITING, city: Linköping, zip: 581 85, country: Sweden, contacts name: Madelene Wedin, MD, PhD, role: CONTACT, email: madelene.wedin@regionostergotland.se, contacts name: Madelene Wedin, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, locations facility: Skåne University Hospital, status: NOT_YET_RECRUITING, city: Lund, zip: 22185, country: Sweden, contacts name: Mihaela Asp, MD, PhD, role: CONTACT, email: Mihaela.Asp@skane.se, contacts name: Mihaela Asp, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Päivi Kannisto, MD, Ass Prof, role: SUB_INVESTIGATOR, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False