The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedDecember 4, 2025
December 1, 2025
2.5 years
March 22, 2023
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
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
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
Study Arms (3)
ENHANCE Intervention Diet and Excerise
EXPERIMENTALParticipants 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.
ENHANCE Intervention Diet Only
EXPERIMENTALParticipants 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.
Usual Care + Fitbit
NO INTERVENTIONParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \>18 years old
- Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
- No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
- Able to speak and read English
- Able to consume food orally
- Willing to consume an alternative Mediterranean diet
- Scheduled to receive treatment with radiation or chemoradiation
- Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
- Able to provide informed consent
You may not qualify if:
- Women who are pregnant
- Head and Neck Cancer not the primary diagnosis
- Patients scheduled to receive surgery
- Patients on enteral or parental nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvia Crowder, PhD
Moffitt Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 5, 2023
Study Start
April 6, 2023
Primary Completion
October 13, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
December 4, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share