Diet Education Program for Stage I-IV Colorectal Cancer Survivors

Study Overview
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Brief Summary
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This pilot trial evaluates the feasibility of a group diet education program for stage I-IV colorectal cancer survivors. Providing a nutrition education program for colon and rectal cancer survivors may help them have better access to the tools necessary to make healthy food decisions that can impact their cancer outcomes.

Detailed Description
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PRIMARY OBJECTIVE: I. To describe the feasibility and acceptability of a group diet education intervention for colorectal cancer (CRC) survivors at Zuckerberg San Francisco General Hospital (ZSFGH). SECONDARY OBJECTIVE: I. To describe perceived barriers to healthy diet among CRC survivors at ZSFGH. EXPLORATORY OBJECTIVES: I. To evaluate for differences in feasibility and acceptability of a group diet education program, based on sociodemographic factors such as education, food insecurity, employment, and race. II. To explore changes in health-related behaviors pre and post intervention using a validated lifestyle score. OUTLINE: Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5). After completion of study, patients are followed up at 12 weeks.

Official Title
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Diet Education Among Colorectal Cancer Survivors in the Safety Net Setting: A Pilot Feasibility Study

Conditions
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Stage IIIB Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8

Intervention / Treatment
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* Dietary Supplement: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to speak and read English or Spanish Diagnosed with stage 1- 4 colorectal cancer within 5 years prior to study enrollment and treated with curative intent Receiving survivorship follow up care at Zuckerberg San Francisco General Hospital (ZSFGH) Able to provide written consent Exclusion Criteria: Currently receiving chemotherapy, biologic therapy, radiation, or immunotherapy for colorectal cancer

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (diet education)<br>Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5). | Dietary Supplement: Dietary Intervention<br>* Attend diet education sessions<br>* Other names: Nutritional Interventions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants missing questionnaires | Feasibility of measurement tools will be assessed by reporting the percentage of participants whom did not complete the questionnaires | Up to 17 weeks | 
| Follow-up response rates | Feasibility of measurement tools will be assessed by follow up response rates (week 6 and week 17) | Up to 17 weeks | 
| Frequency of reasons for not participating in questionnaires | Feasibility of measurement tools will be assessed by recording and reporting reasons for not taking part in questionnaires. | Up to 17 weeks | 
| Number of participants who consent or expressed interest | Subject recruitment will be assessed by number of participants who consent/number of participants who initially expressed interest, and reasons for non-participation will be documented. | Up to 17 weeks | 
| Percentage of consented patients who remain on the study | Subject retention will be assessed by percentage of consented patients who remain on the study at week 6 and at week 17, and reasons for dropout will be documented. | Up to 17 weeks | 
| Number of sessions attended | Adherence to diet education intervention will be assessed by number of sessions attended and reasons for absence will be documented. | Up to 17 weeks | 
| Categorical responses to program evaluation survey | Experience (e.g. satisfaction) will be assessed by tabulated responses to program evaluation survey. Qualitative analysis of cleaned and coded transcripts from interviews using a constant comparison process through which data are built into conceptual categories and themes will be performed. | Up to 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of responses to the baseline socio-demographics survey | Barriers to healthy diet will be described using tabulated responses to the baseline socio-demographics survey and qualitative analysis of coded transcripts from baseline and exit interviews. | Up to 17 weeks |