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The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

Primary Purpose

Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ENHANCE Intervention - Exercise and Nutrition
ENHANCE Intervention - Nutrition Only
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >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 Exclusion Criteria: Women who are pregnant Head and Neck Cancer not the primary diagnosis Patients scheduled to receive surgery Patients on enteral or parental nutrition

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

ENHANCE Intervention Diet and Excerise

ENHANCE Intervention Diet Only

Usual Care + Fitbit

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Recruited - Feasibility
The study will be deemed feasible if ≥ 60% of eligible participants are enrolled
Number of Participants who Complete Questionnaire - Retention - Feasibility
The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
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)
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)
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)
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2023
Last Updated
August 7, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05798780
Brief Title
The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors
Official Title
The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ENHANCE Intervention Diet and Excerise
Arm Type
Experimental
Arm Description
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.
Arm Title
ENHANCE Intervention Diet Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care + Fitbit
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ENHANCE Intervention - Exercise and Nutrition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ENHANCE Intervention - Nutrition Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Recruited - Feasibility
Description
The study will be deemed feasible if ≥ 60% of eligible participants are enrolled
Time Frame
12 Months
Title
Number of Participants who Complete Questionnaire - Retention - Feasibility
Description
The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
Time Frame
12 weeks
Title
Participant Satisfaction of Timeline - Feasibility
Description
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
Title
Participant Average Attendance - Assessment Completion - Adherence
Description
Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)
Time Frame
12 weeks
Title
Number of Participants who Complete Task/Goals - Adherence
Description
Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)
Time Frame
12 weeks
Title
Participant Satisfaction Assessed with 5 Point Scale - Acceptability
Description
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
Title
Participant Intent to Continue Assessed with 5 Point Scale - Acceptability
Description
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.
Time Frame
12 weeks
Title
Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 Exclusion Criteria: Women who are pregnant Head and Neck Cancer not the primary diagnosis Patients scheduled to receive surgery Patients on enteral or parental nutrition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvia Crowder, PhD
Phone
813-745-6849
Email
Sylvia.Crowder@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Crowder, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Bryant
Phone
813-745-2168
Email
Crystal.Bryant@moffitt.org
First Name & Middle Initial & Last Name & Degree
Sylvia Crowder, PhD
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD
First Name & Middle Initial & Last Name & Degree
Heather Jim, PhD
First Name & Middle Initial & Last Name & Degree
James Caudell, MD
First Name & Middle Initial & Last Name & Degree
Kedar Kirtane, MD
First Name & Middle Initial & Last Name & Degree
Bob Gore, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=22330
Description
Moffitt Cancer Center Clinical Trial Search

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The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

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