Clinical trial NCT05746195: Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
Official title: Use of Text Messages to Increase Whole Grain Consumption in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenocarcinoma
Colorectal Carcinoma
Rectal Adenocarcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-27
Enrollment: 48
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 clinical trial evaluates whether an adaptive text-message intervention is useful in helping survivors of colorectal cancers (CRC) eat more whole grain foods and less refined grain foods. Most CRC survivors don't achieve the recommended intakes of whole grains or fiber, even though there is strong evidence that a high-fiber diet rich in whole grains lowers the risk of death from CRC. Dietary interventions are a promising approach for reducing death from CRC, and text message interventions specifically are a promising tool for reaching diverse populations. This trial evaluates a text-message based dietary intervention that continuously adapts message content to be specifically tailored for the participant for increasing whole grain consumption.

Detailed description: PRIMARY OBJECTIVE:

I. Determine the intervention's feasibility and acceptability.

SECONDARY OBJECTIVES:

I. Estimate the effect of the intervention on the percent of grains consumed that are whole.

II. Estimate the effect of the intervention on total fiber intake (grams per day \[g/d\]).

EXPLORATORY OBJECTIVE:

I. Assess convergence of the reinforcement learning (RL) algorithm.

OUTLINE:

Patients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. Patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for Supplemental Nutrition Assistance Program (SNAP) benefits.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Subject has provided informed consent.
3. Diagnosis of colon or rectal adenocarcinoma.
4. Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy) during the study period.
5. At least 6 weeks since a major surgery and fully recovered.
6. Owns a mobile phone and is willing and able to receive and send text messages.
7. Able to speak/read English or Spanish.
8. Based on a screening survey, eat grains and =\<50% of total grains are whole grains.

Exclusion Criteria:

1. Does not meet any of the above inclusion criteria.

Primary outcomes:
measure: Median response rate to text messages
timeFrame: Up to 12 weeks
measure: Overall median score on the System Usability Scale (SUS)
timeFrame: At 12 weeks
measure: Overall score on the Acceptability of Intervention Measure (AIM)
timeFrame: At 12 weeks
measure: Overall score on the Intervention Appropriateness Measure (IAM)
timeFrame: At 12 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: At 12 weeks
Secondary outcomes:
measure: Change in percent of grains that are whole reported on the Food Frequency Questionnaire (FFQ)
timeFrame: Up to 12 weeks
measure: Change in mean total daily fiber intake (g/d) reported on the Food Frequency Questionnaire (FFQ)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Erin Van Blarigan, ScD
role: PRINCIPAL_INVESTIGATOR
References: