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

NCT06278831 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2025-05-04

No results posted yet for this study

Summary

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

Conditions

  • Financial Toxicity

Interventions

OTHER

Questionnaire

Patients will be approached three times throughout the study at the beforementioned interview dates to fill out a questionnaire. They will be contacted via e-mail, telephone and/or mobile app.

Sponsors & Collaborators

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Rami El Shafie, Prof. Dr. · University Medical Center Goettingen

  • Anna L Kreuser · University Medical Center Goettingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-08
Primary Completion
2024-06-03
Completion
2024-10-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278831 on ClinicalTrials.gov