PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study

Head and Neck Cancer Clinical Trial

— PaRTNer  

Official title:

PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03506451
• Other study ID #: Pro00092590
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Financial Stress
• Head and Neck Cancer
• Head and Neck Neoplasms

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