Diet Education Program for Stage I-IV Colorectal Cancer Survivors

NCT04597151 | Completed

• 2 other identifiers: 204511NCI-2020-06808
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Frequency of responses to the baseline socio-demographics survey

  Up to 17 weeks

Other Outcomes (1)

• Change in Lifestyle Score on the National Institute of Health (NIH)/ National Cancer Institute (NCI) Automated Self- Administered 24-hour Dietary Assessment Tool (ASA24)

  Up to 17 weeks

Study Arms (1)

Supportive care (diet education)

EXPERIMENTAL

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

Dietary Supplement: Dietary Intervention

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Attend diet education sessions

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive care (diet education)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Sorbarikor Piawah, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: October 12, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 9, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)