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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03506451
Other study ID # Pro00092590
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 19, 2018
Est. completion date November 29, 2025

Study information

Verified date September 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this single institution, pilot study is to explore the out of pocket (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of head and neck cancer with radiation therapy with or without chemotherapy and surgical resection. The study team will assess how the financial burden of cancer care impacts quality of life as well as treatment-related decision-making from a patient perspective.


Description:

This is a prospective, single institution, survey-based study to assess OOP costs, financial toxicity and pateint reported outcomes (PROs') (including QOL, quality of care, and attitudes/perspectives on the role of cost in treatment decisions). Potential participants are new patient consults in Radiation Oncology Head and Neck Cancer Clinic. Patients with an indication for definitive treatment involving radiation therapy will be approached by study staff and, if amenable, enrolled in the study. After signing informed consent, they will complete a baseline survey assessing socioeconomic household information, baseline symptoms/QOL and baseline costs/financial toxicity. They will be followed prospectively and re-surveyed at 3 and 6 months after completion of radiation therapy. Repeat assessments will document treatment costs and PRO including QOL, financial toxicity, and self-reported quality of care. Patients will be asked to collect all treatment-related bills in a provided binder, which will be reviewed at each survey date. Basic demographic data (including age, sex, race, marital status, zip code, and insurance coverage), comorbidities, smoking status, cancer characteristics (stage, site, histology), treatments received, emergency department visits and hospitalization rates at baseline, end of treatment, 3 months and 6 months after radiation treatment will be collected as part of this study. Disease status and survival will also be assessed from standard of care follow-up visits up to five years after completion of radiation treatment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date November 29, 2025
Est. primary completion date November 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult (18 years or older) patients 2. Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy 3. Be able to read and write in English 4. Able to give informed consent and complete survey materials Exclusion Criteria: 1. Recurrent disease 2. Metastatic disease 3. Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).

Study Design


Intervention

Other:
Demographics questionnaires and the FACT HN questionnaire
Patients will complete a baseline survey assessing socioeconomic household information, baseline symptoms, QOL, and financial toxicity, as well as attitudes toward cost conversations and educational handouts.

Locations

Country Name City State
United States Duke Cancer Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Disease status 5 years
Other Overall survival 5 years
Other Progression free survival 5 years
Primary Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC 3 months post radiation therapy
Primary Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC 6 months post radiation therapy
Primary Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST) Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44. Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary Change in quality of life, as measured by FACT-H&N score Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary Perceived quality of care Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor 3 months post radiation therapy, 6 months post radiation therapy
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