Diet Education Program for Stage I-IV Colorectal Cancer Survivors

Stage IV Colorectal Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597151
• Other study ID #: 204511
• Secondary ID: NCI-2020-06808
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• 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
• 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 IV Colorectal Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Intervention

Dietary Supplement:
• Dietary Intervention
Attend diet education sessions

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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