Prehabilitation Protocol for Head and Neck Cancer Patients

Purpose

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.

Condition

  • Head and Neck Cancer

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aim 2: Prehabilitation Prescription Protocol Group
Participants in this group will be referred to a prehabilitation prescription protocol of nutritional counseling and exercise for HNC patients. Participants will attend for nutritional counseling and exercise sessions for the duration of their radiation therapy (RT) or chemoradiation therapy (CRT) for HNC. The duration of these sessions depends on the participant's treatment plan and the timing of enrollment. Participants will also have three in-person assessments during the study period during the following timepoints (T), to assess feasibility and acceptability of the prehabilitation prescription protocol: Baseline (T1), at the completion of RT/CRT (T2), and 8 weeks after the completion of RT/CRT and the exit survey (T3). Total participation duration is up to 18 weeks.
  • Behavioral: Referral 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.

Recruiting Locations

University of Miami
Miami, Florida 33136
Contact:
Akina Natori, MD, MSPH
(305) 243-6005
akn571@miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Akina Natori, MD, MSPH
(305) 243-6005
akn571@miami.edu