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

• ClinicalTrials.gov Identifier: NCT03506451
• Recruitment Status: Active, not recruiting
• First Posted: April 24, 2018
• Last Update Posted: February 21, 2021
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Other: Demographics questionnaires and the FACT HN questionnaire	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
• Actual Study Start Date: June 19, 2018
• Estimated Primary Completion Date: August 2021
• Estimated Study Completion Date: August 2025

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC [ Time Frame: 3 months post radiation therapy ]
2. Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC [ Time Frame: 6 months post radiation therapy ]
3. Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST) [ Time Frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy ]
   Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44.

Secondary Outcome Measures :

1. Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score [ Time Frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy ]
2. Change in quality of life, as measured by FACT-H&N score [ Time Frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy ]
3. Perceived quality of care [ Time Frame: 3 months post radiation therapy, 6 months post radiation therapy ]
   Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor

Other Outcome Measures:

1. Disease status [ Time Frame: 5 years ]
2. Overall survival [ Time Frame: 5 years ]
3. Progression free survival [ Time Frame: 5 years ]

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Yvonne Mowery, MD PhD; Associate Professor

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03506451
• Other Study ID Numbers: Pro00092590
• First Posted: April 24, 2018
• Last Update Posted: February 21, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

Financial toxicity

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms