Diet Education Program for Stage I-IV Colorectal Cancer Survivors
Primary Purpose
Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Stage I Colorectal Cancer AJCC v8
Eligibility Criteria
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
Sites / Locations
- Zuckerberg San Francisco General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (diet education)
Arm Description
Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).
Outcomes
Primary Outcome Measures
Percentage of participants missing questionnaires
Feasibility of measurement tools will be assessed by reporting the percentage of participants whom did not complete the questionnaires
Follow-up response rates
Feasibility of measurement tools will be assessed by follow up response rates (week 6 and week 17)
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.
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.
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.
Number of sessions attended
Adherence to diet education intervention will be assessed by number of sessions attended and reasons for absence will be documented.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04597151
First Posted
October 14, 2020
Last Updated
January 5, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04597151
Brief Title
Diet Education Program for Stage I-IV Colorectal Cancer Survivors
Official Title
Diet Education Among Colorectal Cancer Survivors in the Safety Net Setting: A Pilot Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (diet education)
Arm Type
Experimental
Arm Description
Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Attend diet education sessions
Primary Outcome Measure Information:
Title
Percentage of participants missing questionnaires
Description
Feasibility of measurement tools will be assessed by reporting the percentage of participants whom did not complete the questionnaires
Time Frame
Up to 17 weeks
Title
Follow-up response rates
Description
Feasibility of measurement tools will be assessed by follow up response rates (week 6 and week 17)
Time Frame
Up to 17 weeks
Title
Frequency of reasons for not participating in questionnaires
Description
Feasibility of measurement tools will be assessed by recording and reporting reasons for not taking part in questionnaires.
Time Frame
Up to 17 weeks
Title
Number of participants who consent or expressed interest
Description
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.
Time Frame
Up to 17 weeks
Title
Percentage of consented patients who remain on the study
Description
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.
Time Frame
Up to 17 weeks
Title
Number of sessions attended
Description
Adherence to diet education intervention will be assessed by number of sessions attended and reasons for absence will be documented.
Time Frame
Up to 17 weeks
Title
Categorical responses to program evaluation survey
Description
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.
Time Frame
Up to 17 weeks
Secondary Outcome Measure Information:
Title
Frequency of responses to the baseline socio-demographics survey
Description
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.
Time Frame
Up to 17 weeks
Other Pre-specified Outcome Measures:
Title
Change in Lifestyle Score on the National Institute of Health (NIH)/ National Cancer Institute (NCI) Automated Self- Administered 24-hour Dietary Assessment Tool (ASA24)
Description
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.
Time Frame
Up to 17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sorbarikor Piawah, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Diet Education Program for Stage I-IV Colorectal Cancer Survivors
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