Diet Education Program for Stage I-IV Colorectal Cancer Survivors

Not Applicable

Completed

• Conditions: Stage IIIB Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage I Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8
• Interventions: Dietary Supplement: Dietary Intervention

• Registration Number: NCT04597151
• Lead Sponsor: University of California, San Francisco

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-12
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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Exclusion Criteria

• Currently receiving chemotherapy, biologic therapy, radiation, or immunotherapy for colorectal cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (diet education)	Dietary Intervention	Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).

Primary Outcome Measures

Name	Time	Method
Number of participants who consent or expressed interest	Up to 17 weeks	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.
Frequency of reasons for not participating in questionnaires	Up to 17 weeks	Feasibility of measurement tools will be assessed by recording and reporting reasons for not taking part in questionnaires.
Percentage of participants missing questionnaires	Up to 17 weeks	Feasibility of measurement tools will be assessed by reporting the percentage of participants whom did not complete the questionnaires
Follow-up response rates	Up to 17 weeks	Feasibility of measurement tools will be assessed by follow up response rates (week 6 and week 17)
Percentage of consented patients who remain on the study	Up to 17 weeks	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.
Categorical responses to program evaluation survey	Up to 17 weeks	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.
Number of sessions attended	Up to 17 weeks	Adherence to diet education intervention will be assessed by number of sessions attended and reasons for absence will be documented.

Secondary Outcome Measures

Name	Time	Method
Frequency of responses to the baseline socio-demographics survey	Up to 17 weeks	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.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States