Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Colorectal Carcinoma; Rectal Adenocarcinoma; Colon Adenocarcinoma

Treatments: Behavioral: Nutrition Education; Other: Survey Administration; Behavioral: Dietary intervention via Text Messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05746195

NCI-2023-00870 (Registry Identifier)

R21CA263539 (U.S. NIH Grant/Contract)

224523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Text message intervention

Experimental group

Description:

Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.

Treatment:

Behavioral: Dietary intervention via Text Messaging

Other: Survey Administration

Behavioral: Nutrition Education