What this study is
The purpose of this research is to help researchers understand the barriers, supports, and preferences for prehabilitation. Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs before and during radiotherapy/chemoradiotherapy treatment.
What's being tested
- Referral to Oncology Nutritional Counseling and Exercise Program
Intervention · BEHAVIORAL
Participants will be referred by their healthcare provider to an oncology nutritional counseling and exercise program administered standard of care by the Cancer Support Service at the Sylvester Comprehensive Cancer Center. Participants will be scheduled to the predetermined frequency and length of visits with oncology dietitians and exercise physiologists per the prehabilitation prescription protocol developed during the pre-implementation period.
Study details
- Official title
- Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period
- Sponsor
- University of Miami
- Conditions
- Head and Neck Cancer
- Enrolling
- 60 people
- Starts
- 2026-05-01
- Est. completion
- 2027-08-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Aim 2 Inclusion Criteria: Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients.
- Age 18 to 80 years old
- Patients with a diagnosis of squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
- Stage I-III or de novo Stage IV
- Patients with a plan for radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC* - *Patients who underwent surgery for the HNC are still eligible.
- If this is a second primary squamous cell carcinoma originating in the head and neck, a patient is eligible if the last RT or CRT was completed more than 6 months ago.
- Clearance for exercise by the medical team.
- Patients who do not have their first treatment scheduled within 7 days at the time of recruitment.
- An English or Spanish speaker. Aim 2 Exclusion Criteria:
- A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
- Any contraindication for diet change or exercising as determined by a physician.
- A patient who is not an English or Spanish speaker.
- History of dementia or major psychiatric disease which would interfere with study.
- History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Miami
Miami, Florida, United States
- Akina Natori, MD, MSPH · Contact(305) 243-6005akn571@miami.edu
- Akina Natori, MD, MSPH · Principal investigator
- Tracy E Crane, PhD, RDN · Principal investigator
- Frank Penedo, PhD · Principal investigator
- Melissa Pentecost-Lopez, PhD, MS, RDN · Principal investigator
- Erin R Kaye, MD · Principal investigator
- Stuart Samuels, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Miami
Study ID 20230516
Principal investigator
Akina Natori, MD, MSPH
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.