Diet Education Program for Stage I-IV Colorectal Cancer Survivors

NCT ID: NCT04597151

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2021-08-31

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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (diet education)

Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type DIETARY_SUPPLEMENT

Attend diet education sessions

Interventions

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Dietary Intervention

Attend diet education sessions

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sorbarikor Piawah, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2020-06808

Identifier Type: REGISTRY

Identifier Source: secondary_id

204511

Identifier Type: -

Identifier Source: org_study_id

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