Diet Education Program for Stage I-IV Colorectal Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8
• Intervention / Treatment: Dietary supplement: Dietary Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (diet education); Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).	Dietary supplement: Dietary Intervention; Attend diet education sessions; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lifestyle Score on the National Institute of Health (NIH)/ National Cancer Institute (NCI) Automated Self- Administered 24-hour Dietary Assessment Tool (ASA24)	The ASA24® Dietary Assessment Tool is a free, web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. The ASA24 system consists of a respondent website used to collect dietary intake data and a researcher website used to manage study logistics and obtain nutrient and food group data files to obtain analysis files for 65 nutrients and 37 food groups. This data is used to generate a standardized lifestyle score pre- and post-intervention with possible range: 0-7, based on participant's body mass index and intake of fruits and vegetables, fiber, ultra-processed foods, red meat, processed meat, sugar-sweetened drinks, and alcohol. This standardized score quantifies the degree to which participants' lifestyles are consistent with the 2018 World Cancer Research Fund (WCRF) / American Institute of Cancer Research (AICR) Recommendations.	Up to 17 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Sorbarikor Piawah, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 204511; NCI-2020-06808 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No