Clinical Trial 22330

• Overview

  Study Title:

  The ENHANCE Study: Exercise and Nutrition in Head and neck And luNg CancEr Survivors: A Randomized Clinical Trial

  Summary:

  The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

  Objective:

  Aim 1: Establish feasibility/acceptability of the ENHANCE- Exercise and Nutrition in Head And Neck CancEr intervention via a pilot RCT in HNC patients. Approach: Recruit n=40 HNC patients (n=20 ENHANCE, n=20 Control Group Usual Care+Fitbit). Goal: Evaluate a set of feasibility and acceptability benchmarks including: a) Feasibility: rates of recruitment b) Adherence: session completion rate and behavior change. c) Acceptability: participant ratings of satisfaction with the intervention d) Sensitivity assessment (exploratory): BIA measures, QOL, FitBit, and diet at baseline (pre-treatment) and 12-week (post-treatment) follow-up to inform the future R01. Aim 2: Further revise and refine the ENHANCE intervention. Approach: Based on data and survey responses in Aim 1, we will further refine and revise the intervention to best meet the unique needs of HNC patients.

• Inclusion Criteria

  • >18 years old
  • Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
  • No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
  • Able to speak and read English
  • Able to consume food orally
  • Willing to consume an alternative Mediterranean diet
  • Scheduled to receive treatment with radiation or chemoradiation
  • Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
  • Able to provide informed consent

• Exclusion Criteria

  • Women who are pregnant
  • Head and Neck Cancer not the primary diagnosis
  • Patients scheduled to receive surgery
  • Patients on enteral or parental nutrition

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