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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Demographics questionnaires and the FACT HN questionnaire

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm non-therapeutic interventional study; All subjects who enroll on study will be asked to complete questionnaires at baseline before treatment starts; the questionnaires are repeated at one month, three and six months after radiation therapy has been completed. the demographics questionnaire is completed at baseline only; the FACT-HN is completed at all four time points.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC		3 months post radiation therapy
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC		6 months post radiation therapy
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in quality of life, as measured by FACT-H&N score		Baseline, 3 months post radiation therapy, 6 months post radiation therapy
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

Other Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Progression free survival	5 years
Disease status	5 years

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Yvonne Mowery, MD PhD, Duke University Health System (DUHS); Principal Investigator: David Brizel Brizel, MD, Duke University Health System (DUHS)

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): November 29, 2021
• Study Completion (Estimated): November 29, 2025

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Financial toxicity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms; Neoplasms by Site; Stress, Psychological; Head and Neck Neoplasms; Financial Stress
• Other Study ID Numbers: Pro00092590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No