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RecruitingInterventional

Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period

NCT ID: NCT07318220Sponsor: University of MiamiLast updated: 2026-06-17

Summary

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.

Arms & interventions

  • BehavioralReferral to Oncology Nutritional Counseling and Exercise Program

    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.

Outcome measures

Primary

  • Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program

    Feasibility will be measured as the percentage of participants that agree to participate in the prehabilitation prescription protocol. Criterion for success: At least (≥) 50% of all eligible participants agree to participate in the prehabilitation prescription protocol.

    Time frame: Up to 18 Weeks

  • Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol

    Feasibility will be measured as the percentage of participants attending scheduled visits of the prehabilitation prescription protocol. Criterion for success: At least (≥) 70% of participants attend all scheduled visits.

    Time frame: Up to 18 Weeks

  • Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol

    Acceptability will be measured as the percentage of participants that report satisfaction with the prehabilitation prescription protocol. Criterion for success: At least (≥) 80% of participants complete the prehabilitation prescription protocol.

    Time frame: Up to 18 Weeks

Eligibility criteria

Sex: AllAge: 18 Years to 80 YearsHealthy volunteers: Yes
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. 1. Age 18 to 80 years old 2. Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx). 3. Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible. 4. Clearance for exercise by the medical team. 5. Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment. 6. An English or Spanish speaker. Aim 2 Exclusion Criteria: 1. A patient with a metastatic cancer. 2. A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT. 3. Any contraindication for diet change or exercising as determined by a physician. week for the prior month. 4. A patient who is not an English or Spanish speaker. 5. History of dementia or major psychiatric disease which would interfere with study. 6. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure 7. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.

Study locations (1)

University of Miami

Miami, Florida, 33136

Recruiting
Akina Natori, MD, MSPH · Contact
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
Prehabilitation Protocol for Head and Neck Cancer Patients | Cancerify