Head and Neck Cancer
Conditions
Brief 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.
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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 squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx). 3. Stage I-III or de novo Stage IV 4. Patients with a plan for radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible. 5. 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. 6. Clearance for exercise by the medical team. 7. Patients who do not have their first treatment scheduled within 7 days at the time of recruitment. 8. An English or Spanish speaker. Aim 2
Exclusion criteria
1. A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT. 2. Any contraindication for diet change or exercising as determined by a physician. 3. A patient who is not an English or Spanish speaker. 4. History of dementia or major psychiatric disease which would interfere with study. 5. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure 6. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program | Up to 18 Weeks | 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. |
| Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol | Up to 18 Weeks | 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. |
| Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol | Up to 18 Weeks | 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. |
Countries
United States
Contacts
CONTACTAkina Natori, MD, MSPH
PRINCIPAL_INVESTIGATORAkina Natori, MD, MSPH
University of Miami
Outcome results
None listed