protocolSection identificationModule nctId: NCT06278831, orgStudyIdInfo id: 2023-02645, briefTitle: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy, acronym: SOCOFIN-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-08, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University Medical Center Goettingen, class: OTHER, descriptionModule briefSummary: Objectives:* Assess the extent of financial burden of patients undergoing radiotherapy* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity* Design a structured social consultation to reduce financial burden induced by radiotherapyInclusion criteria:1. age ≥ 18 years of age2. indication for radiation treatment of a malignant disease3. Karnofsky Performance score (KPS) ≥ 70%4. Life expectancy ≥ 3 monthsExclusion criteria:1. Inability to provide informed consent2. Inability to attend study visits and fulfill data collection requirements3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapySecondary outcomes:* Socio-Economic factors at baseline* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months* Depression (PHQ-9) at baseline and 3 months* Coping mechanisms to address financial burdenPrimary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.Secondary Endpoints:* Changes in the COST-Score over time* Changes in PHQ-9 over time* Changes in EORTC QLQ-C30 over timeThis is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120, conditionsModule conditions: Financial Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Financial Toxicity, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Göttingen, status: RECRUITING, city: Göttingen, state: Niedersachsen, zip: 37075, country: Germany, contacts name: Rami El Shafie, Prof. Dr., role: CONTACT, phone: +4955164505, email: rami.elshafie@med.uni-goettingen.de, geoPoint lat: 51.53443, lon: 9.93228, hasResults: False