Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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.
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.
- •Engaging in \>150 minutes of moderate to vigorous physical activity on average per 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.
Outcomes
Primary Outcomes
Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Akina Natori
Research Assistant Professor
University of Miami