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

NCT06278831 | Completed

• 1 other identifier: 2023-02645
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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:
• age ≥ 18 years of age
• indication for radiation treatment of a malignant disease
• Karnofsky Performance score (KPS) ≥ 70%
• Life expectancy ≥ 3 months
• Inability to provide informed consent
• Inability to attend study visits and fulfill data collection requirements
• 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
• 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

Outcome Measures

Primary Outcomes (1)

• Financial Toxicity

  Measure instrument: Comprehensive Score for financial Toxicity COST score. COST score ranges from 0 (severe) to 44 points (no effect). Primary endpoint: Changes in COST-Score over time. Assessment before radiation therapy, after and 3 months after.

  4 months

Secondary Outcomes (4)

• Factors that may influence the occurrence or extent of financial burden

  4 months

• Factors that may influence the occurrence or extent of financial burden

  4 months

• Factors that may influence the occurrence or extent of financial burden

  4 months

• Factors that may influence the occurrence or extent of financial burden

  4 months

Interventions

Questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria.

You may qualify if:

• cancer diagnosis with indication for radiation
• Karnofsky index minimum 70%
• able to consent
• minimum 18 years old

You may not qualify if:

• Inability to provide informed consent
• Inability to attend study visits and fulfill data collection requirements
• Simultaneous participation in other studies which could interfere with this study

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (5)

• Huntington SF, Weiss BM, Vogl DT, Cohen AD, Garfall AL, Mangan PA, Doshi JA, Stadtmauer EA. Financial toxicity in insured patients with multiple myeloma: a cross-sectional pilot study. Lancet Haematol. 2015 Oct;2(10):e408-16. doi: 10.1016/S2352-3026(15)00151-9. Epub 2015 Sep 17.

  PMID: 26686042 BACKGROUND

• Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26.

  PMID: 23442307 BACKGROUND

• Bestvina CM, Zullig LL, Rushing C, Chino F, Samsa GP, Altomare I, Tulsky J, Ubel P, Schrag D, Nicolla J, Abernethy AP, Peppercorn J, Zafar SY. Patient-oncologist cost communication, financial distress, and medication adherence. J Oncol Pract. 2014 May;10(3):162-7. doi: 10.1200/JOP.2014.001406.

  PMID: 24839274 BACKGROUND

• Fenn KM, Evans SB, McCorkle R, DiGiovanna MP, Pusztai L, Sanft T, Hofstatter EW, Killelea BK, Knobf MT, Lannin DR, Abu-Khalaf M, Horowitz NR, Chagpar AB. Impact of financial burden of cancer on survivors' quality of life. J Oncol Pract. 2014 Sep;10(5):332-8. doi: 10.1200/JOP.2013.001322. Epub 2014 May 27.

  PMID: 24865220 BACKGROUND

• Ramsey SD, Bansal A, Fedorenko CR, Blough DK, Overstreet KA, Shankaran V, Newcomb P. Financial Insolvency as a Risk Factor for Early Mortality Among Patients With Cancer. J Clin Oncol. 2016 Mar 20;34(9):980-6. doi: 10.1200/JCO.2015.64.6620. Epub 2016 Jan 25.

  PMID: 26811521 BACKGROUND

MeSH Terms

Conditions

Financial Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rami El Shafie, Prof. Dr.

  University Medical Center Goettingen

  PRINCIPAL INVESTIGATOR

• Anna L Kreuser

  University Medical Center Goettingen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of UMG Radiotherapy

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 26, 2024
• Study Start: July 8, 2023
• Primary Completion: June 3, 2024
• Study Completion: October 15, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

DE (1)