Diet Intervention, Head and Neck Cancer, Feasibility

Study Overview
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Brief Summary
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This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.

Official Title
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Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Cruciferous and Dark Leafy Green Intervention
* Behavioral: Usual Dietary Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking Exclusion Criteria: Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Dietary Care<br>Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly. | Behavioral: Usual Dietary Care<br>* Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.<br>|
| Experimental: Cruciferous and Dark Leafy Green Intervention<br>Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant. | Behavioral: Cruciferous and Dark Leafy Green Intervention<br>* Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients excluded or not agreeing to participate | Feasibility measure | Baseline | 
| Adherence to study protocol activities (research records and diet intake self-report) | Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.) | Throughout 12 week study period | 
| Attrition rates | Feasibility measure | Throughout 12 week study period | 
| Adverse events with reporting according to institutional review board policy |  | Throughout 12 week study period | 
| Questionnaire | Participant satisfaction | At conclusion of 12 week study period | 
| Questionnaire | Intervention preferences | At conclusion of 12 week study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation |  | At beginning and end of 12 week study period | 
| Serum cytokines |  | At beginning and end of 12 week study period | 
| Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index) |  | At beginning and end of 12 week study period | 
| Total energy and nutrient intakes |  | At beginning and end of 12 week study period | 
| Covariates | A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses). This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight) | At beginning of 12 week study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, nutrition, survival, recurrence, cruciferous, dark leafy greens