NCT06278831: SOCOFIN-1

Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy

Completed Last updated 4 May 2025

What this trial tests

trial testing Questionnaire in Financial Toxicity in 230 participants. Completed in 15 October 2024.

Timeline

8 July 2023

Primary endpoint
3 June 2024

15 October 2024

Quick facts

Lead sponsor	University Medical Center Goettingen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	230
Start date	8 July 2023
Primary completion	3 June 2024
Estimated completion	15 October 2024
Sites	1 location across Germany

Drugs / interventions tested

• Questionnaire

Conditions studied

• Financial Toxicity — all drugs for Financial Toxicity →

Sponsor

University Medical Center Goettingen

Who can join

18 and older, any sex, with Financial Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 radiotherapy

Inclusion criteria:

1. age ≥ 18 years of age
2. indication for radiation treatment of a malignant disease
3. Karnofsky Performance score (KPS) ≥ 70%
4. Life expectancy ≥ 3 months

Exclusion criteria:

1. Inability to provide informed consent
2. Inability to attend study visits and fulfill data collection requirements
3. 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 radiotherapy

Secondary 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 burden

Primary 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 time

This 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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Longitudinal development and clinical predictors of financial toxicity among radiation oncology patients: final results of the SOCOFIN study.
   Kreuser AL, Ziegler S, Bendrich S, Ziegler A, et al · · 2026 · cited 2× · PMID 41128858 · DOI 10.1007/s00066-025-02479-9