Prehabilitation Protocol for Head and Neck Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Referral to Oncology Nutritional Counseling and Exercise Program.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period
Overview
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
- 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.
Primary outcome measures
- Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program [Time frame: Up to 18 Weeks]
- Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol [Time frame: Up to 18 Weeks]
- Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol [Time frame: Up to 18 Weeks]
Eligibility 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.
- Age 18 to 80 years old
- Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
- Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible.
- Clearance for exercise by the medical team.
- Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.
- An English or Spanish speaker.
Aim 2 Exclusion Criteria:
- A patient with a metastatic cancer.
- 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.
week for the prior month.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT07318220 · 20230516