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

NCT03506451 | Completed

• 1 other identifier: Pro00092590
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Financial toxicity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

  3 months post radiation therapy, 6 months post radiation therapy

Other Outcomes (3)

• Disease status

  5 years post completion of radiation treatment

• Overall survival

  5 years post completion of radiation treatment

• Progression free survival

  5 years post completion of radiation treatment

Study Arms (1)

Single arm non-therapeutic interventional study

OTHER

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

Interventions

Demographics questionnaires and the FACT HN questionnaire OTHER

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.

Single arm non-therapeutic interventional study

Eligibility Criteria

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

You may qualify if:

• Adult (18 years or older) patients
• Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy
• Be able to read and write in English
• Able to give informed consent and complete survey materials

You may not qualify if:

• Recurrent disease
• Metastatic disease

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Pooja Karukonda, MD

  Duke University Health System (DUHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: April 24, 2018
• Study Start: June 19, 2018
• Primary Completion: November 29, 2021
• Study Completion: April 13, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)