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

NCT05746195 | Completed Results

• 3 other identifiers: 224523NCI-2023-00870R21CA263539
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Adenocarcinoma; Colorectal Carcinoma; Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (5)

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

  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%.

  Up to 12 weeks

• Overall Median Score on the System Usability Scale (SUS)

  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.

  At 12 weeks

• Overall Score on the Acceptability of Intervention Measure (AIM)

  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.

  At 12 weeks

• Overall Score on the Intervention Appropriateness Measure (IAM)

  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.

  At 12 weeks

• Feasibility of Intervention Measure (FIM)

  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.

  At 12 weeks

Secondary Outcomes (2)

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

  Up to 12 weeks

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

  Up to 12 weeks

Study Arms (1)

Text message intervention

EXPERIMENTAL

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.

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

Interventions

Dietary intervention via Text Messaging BEHAVIORAL

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

Text message intervention

Survey Administration OTHER

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

Text message intervention

Nutrition Education BEHAVIORAL

Participants will receive nutrition education materials

Text message intervention

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Rectal Neoplasms

Interventions

Nutrition Assessment

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)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Erin Van Blarigan, ScD
• Organization: University of California, San Francisco

Erin.VanBlarigan@ucsf.edu

(415) 476-1000

Study Officials

• Erin Van Blarigan, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: February 17, 2023
• First Posted: February 27, 2023
• Study Start: November 3, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)