The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
During radiation, participants will attend in-person supervised resistance training sessions once a week for 7 weeks, followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks, after radiation. Sessions will last approximately 30 minutes. During radiation, participants will be provided 15 meals each week for 7 weeks, 105 meals total. Participants will be asked to participate in 1 weekly dietary coaching session (in-person during radiation and video conference following radiation), create weekly SMART goals, follow an alternative Mediterranean diet pattern, and log all meals, snacks, and supplements consumed for the 12-week intervention.
During chemoradiotherapy, participants will be provided 15 meals each week for 7 weeks (105 meals total) that will accommodate common NIS concerns (ex. dysphagia and difficulty chewing) following an aMED dietary pattern (5 breakfast, 5 lunch, and 5 dinner), will be taught proper portion size, and will be asked to record percentages of each meal consumed in a provided food journal, in addition to any outside meals, snacks, or nutritional supplements. They will be provided with dietary coaching weekly to discuss NIS, aMED diet compliance, and set weekly SMART goals (approximately 30 min). Following completion of chemoradiotherapy (5 weeks), participants will be provided dietary coaching weekly (in-person or via videoconference), discuss NIS, aMED diet compliance at home, and set weekly SMART goals (30 min). Trainers will monitor participants' Fitbit active minutes in real time throughout the intervention period and provide aerobic exercise encouragement accordingly.
Moffitt Cancer Center
Tampa, Florida, United States
Number of Participants Recruited - Feasibility
The study will be deemed feasible if ≥ 60% of eligible participants are enrolled
Time frame: 12 Months
Number of Participants who Complete Questionnaire - Retention - Feasibility
The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
Time frame: 12 weeks
Participant Satisfaction of Timeline - Feasibility
The study will be deemed feasible if ≥ 70% of participants like the timing of the intervention using a likert scale (scale range Strongly agree to Strongly disagree)
Time frame: 12 weeks
Participant Average Attendance - Assessment Completion - Adherence
Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)
Time frame: 12 weeks
Number of Participants who Complete Task/Goals - Adherence
Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)
Time frame: 12 weeks
Participant Satisfaction Assessed with 5 Point Scale - Acceptability
Participants satisfaction will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
Time frame: 12 weeks
Participant Intent to Continue Assessed with 5 Point Scale - Acceptability
Participants intent to continue will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
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Time frame: 12 weeks
Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability
Participants knowledge gained will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
Time frame: 12 weeks