The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial

NCT05798780 NA ACTIVE_NOT_RECRUITING

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	40
Start date	2023-04-06
Completion	2026-07

Conditions

• Oral Cavity Cancer
• Oropharynx Cancer
• Hypopharynx Cancer
• Larynx Cancer

Interventions

• ENHANCE Intervention - Exercise and Nutrition
• ENHANCE Intervention - Nutrition Only

Primary outcomes

• 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.

Countries

United States