Prehabilitation Protocol for Head and Neck Cancer Patients
ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
A patient who is not an English or Spanish speaker.
Trial design
Design model
Single group
Treatments tested in this trial
Referral to Oncology Nutritional Counseling and Exercise Program
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Aim 2: Prehabilitation Prescription Protocol GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 Weeks2
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 Weeks3
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 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov