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Clinical Trial 19181

Cancer Type: Head & Neck

Study Type: Other
Phase of Study: N/A

  • Heather Jim

Call 813-745-6100
or 1-800-679-0775

Study Title

Patient-Reported Outcomes in Immunotherapy for Head and Neck Cancer


The purpose of this study is to better understand toxicity of immune checkpoint inhibitors (ICIs) (e.g., nivolumab, pembrolizumab) from the patient's perspective, identify risk factors for toxicity, examine the impact of toxicity on quality of life, and explore associations of patient reported symptoms with cancer progression or until the end of clinical trial participation if patients are on clinical trials.


Aim 1: To describe the prevalence and course of patient-reported toxicity in patients treated with immune checkpoint inhibitors for head and neck cancer. It is hypothesized that patients treated with ICIs as part of standard care will report toxicities such as fatigue, musculoskeletal pain, rash, diarrhea, rash, pruritus. Aim 2: To identify sociodemographic, behavioral, and clinical risk factors for patient-reported toxicity. It is hypothesized that sociodemographic, behavioral, and clinical factors (e.g., age, smoking, comorbidities, performance status, and PD-L1 expression) will be risk factors for toxicity. Aim 3: To determine the impact of patient-reported toxicity on quality of life. It is hypothesized that more severe toxicity will be associated with worse quality of life.

Inclusion Criteria

  • Eligible participants will be individuals who:
  • are aged 18 years or older,
  • have a diagnosis of head or neck cancer,
  • are scheduled to begin treatment with an immune checkpoint inhibitor as monotherapy or combination therapy at Moffitt Cancer Center,
  • are able to read and speak standard English, and
  • are capable of providing written informed consent.
  • Patients may be dual-enrolled on the current study and a clinical trial.

  • Exclusion Criteria

  • Does not meet any of the Inclusion Criteria.