Clinical trial NCT04597151: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of participants missing questionnaires
timeFrame: Up to 17 weeks
measure: Follow-up response rates
timeFrame: Up to 17 weeks
measure: Frequency of reasons for not participating in questionnaires
timeFrame: Up to 17 weeks
measure: Number of participants who consent or expressed interest
timeFrame: Up to 17 weeks
measure: Percentage of consented patients who remain on the study
timeFrame: Up to 17 weeks
measure: Number of sessions attended
timeFrame: Up to 17 weeks
measure: Categorical responses to program evaluation survey
timeFrame: Up to 17 weeks
Secondary outcomes:
measure: Frequency of responses to the baseline socio-demographics survey
timeFrame: Up to 17 weeks
Other outcomes:
measure: Change in Lifestyle Score on the National Institute of Health (NIH)/ National Cancer Institute (NCI) Automated Self- Administered 24-hour Dietary Assessment Tool (ASA24)
timeFrame: Up to 17 weeks
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sorbarikor Piawah, MD
role: PRINCIPAL_INVESTIGATOR
References: