PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study (PaRTNer)
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demographics questionnaires and the FACT HN questionnaire
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Cancer focused on measuring Financial toxicity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Recurrent disease
- Metastatic disease
- Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).
Sites / Locations
- Duke Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm non-therapeutic interventional study
Arm Description
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.
Outcomes
Primary Outcome Measures
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
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.
Secondary Outcome Measures
Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score
Change in quality of life, as measured by FACT-H&N score
Perceived quality of care
Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03506451
Brief Title
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
Acronym
PaRTNer
Official Title
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Financial toxicity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm non-therapeutic interventional study
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Demographics questionnaires and the FACT HN questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)
Description
Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44.
Time Frame
Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Perceived quality of care
Description
Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor
Time Frame
3 months post radiation therapy, 6 months post radiation therapy
Other Pre-specified Outcome Measures:
Title
Disease status
Time Frame
5 years
Title
Overall survival
Time Frame
5 years
Title
Progression free survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Recurrent disease
Metastatic disease
Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Mowery, MD PhD
Organizational Affiliation
Duke University Health System (DUHS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Brizel Brizel, MD
Organizational Affiliation
Duke University Health System (DUHS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
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