Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03506451
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : June 2021
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. English-speaking
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506451


Contacts
Layout table for location contacts
Contact: Bijal Shah, MS 919 6683726 shah@neuro.duke.edu
Contact: Joan Cahill, BNS OCN CCRP 919 6683726

Locations
Layout table for location information
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Bijal Shah, MS    919-668-3726      
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Yvonne Mowery, MD PhD Associate Professor

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03506451     History of Changes
Other Study ID Numbers: Pro00092590
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms