The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors
Study Details
Study Description
Brief Summary
The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ENHANCE Intervention 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. |
Behavioral: ENHANCE Intervention
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.
|
| No Intervention: Usual Care + Fitbit 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. |
Outcome Measures
Primary Outcome Measures
- Number of Participants Recruited - Feasibility [12 Months]
The study will be deemed feasible if ≥ 60% of eligible participants are enrolled
- Number of Participants who Complete Questionnaire - Retention - Feasibility [12 weeks]
The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
- Participant Satisfaction of Timeline - Feasibility [12 weeks]
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)
- Participant Average Attendance - Assessment Completion - Adherence [12 weeks]
Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)
- Number of Participants who Complete Task/Goals - Adherence [12 weeks]
Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)
- Participant Satisfaction Assessed with 5 Point Scale - Acceptability [12 weeks]
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.
- Participant Intent to Continue Assessed with 5 Point Scale - Acceptability [12 weeks]
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.
- Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability [12 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old
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Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
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No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
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Able to speak and read English
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Able to consume food orally
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Willing to consume an alternative Mediterranean diet
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Scheduled to receive treatment with radiation or chemoradiation
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Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
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Able to provide informed consent
Exclusion Criteria:
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Women who are pregnant
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Head and Neck Cancer not the primary diagnosis
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Patients scheduled to receive surgery
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Patients on enteral or parental nutrition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
Investigators
- Principal Investigator: Sylvia Crowder, PhD, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-22330