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The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENHANCE Intervention Diet and Excerise | Experimental | Participants will participate in 2 in-person supervised resistance training sessions every week for the 7 weeks (during radiation), followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks (after radiation). During radiation, participants will be provided 15 meals each week for 7 weeks. Participants will also attend weekly dietary coaching sessions. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity. |
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| ENHANCE Intervention Diet Only | Experimental | Participants will be provided 15 meals each week for 7 weeks 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. 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). Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity. |
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| Usual Care + Fitbit | No Intervention | Participants will receive handouts with diet and exercise education. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENHANCE Intervention - Exercise and Nutrition | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited - Feasibility | The study will be deemed feasible if ≥ 60% of eligible participants are enrolled | 12 Months |
| Number of Participants who Complete Questionnaire - Retention - Feasibility | The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire. | 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) | 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) | 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) | 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. | 12 weeks |
| Participant Intent to Continue Assessed with 5 Point Scale - Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Crowder, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trial Search | View source |
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| ENHANCE Intervention - Nutrition Only | Behavioral | 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. |
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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. |
| 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. | 12 weeks |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
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