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Completed

NCT Number: NCT05746195

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

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.

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Key information

Conditions

Colon Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Adenocarcinoma Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Subject has provided informed consent.
  • Diagnosis of colon or rectal adenocarcinoma.
  • 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.
  • At least 6 weeks since a major surgery and fully recovered.
  • Owns a mobile phone and is willing and able to receive and send text messages.
  • Able to speak/read English or Spanish.
  • Based on a screening survey, eat grains and =<50% of total grains are whole grains.

Exclusion criteria

  • Does not meet any of the above inclusion criteria.

Treatment and study plan

Dietary intervention via Text Messaging

Behavioral

Text messages will be sent to participants cell phones using the HealthySMS platform

Survey Administration

Other

Various questionnaires evaluating participants dietary habits and use of study intervention will be administered

Nutrition Education

Behavioral

Participants will receive nutrition education materials

Primary outcomes

  1. Median Percentage of Text Messages That Participants Responded to That Asked for a Reply

    Time frame: Up to 12 weeks

    The percentage of text messages responded to is defined as the number of text messages with a response divided by the total number of text messages that ask for a reply and calculated on a per patient basis. The intervention will be determined feasible if the median response rate (percentage of text messages that participants responded to) across all participants is >= 70%.

  2. Overall Median Score on the System Usability Scale (SUS)

    Time frame: At 12 weeks

    The system usability is comprised of 10 questions assessing participants perceived usability of the intervention. Each item is scored on a scale of 1 (strongly disagree) to 5 ( strongly agree). The SUS yields a single number representing a composite measure of the overall usability of the text messaging system. To calculate the SUS score, Each item's score contribution will ultimately range from 0 to 4 (For items 1,3,5,7,and 9 the score contribution is the item score minus 1 and for items 2,4,6,8 and 10, the contribution is the item score minus 5). The sum of the scores are then multiplied by 2.5 to obtain the overall value. SUS scores have a range of 0 to 100 with a score > 68 indicating above average usability.

  3. Overall Score on the Acceptability of Intervention Measure (AIM)

    Time frame: At 12 weeks

    The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is >= 4.

  4. Overall Score on the Intervention Appropriateness Measure (IAM)

    Time frame: At 12 weeks

    The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is >= 4.

  5. Feasibility of Intervention Measure (FIM)

    Time frame: At 12 weeks

    The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is >= 4.

Secondary outcomes

  1. Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ)

    Time frame: Up to 12 weeks

    The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to >=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. Percent of grains that are whole = servings per day of whole grains/(servings per day of refined grains + servings per day of whole grains) will be reported over time

  2. Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ)

    Time frame: Up to 12 weeks

    The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to >=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. The mean total daily fiber intake and standard deviation will be reported over time.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Use of Text Messages to Increase Whole Grain Consumption in Colorectal Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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