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NCT05746195

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

Completed NA Results posted Last updated 22 January 2026
What this trial tests

NA trial testing Dietary intervention via Text Messaging in Colon Adenocarcinoma in 46 participants. Completed in 30 November 2024.

Timeline
3 November 2023
Primary endpoint
30 November 2024
30 November 2024

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment46
Start date3 November 2023
Primary completion30 November 2024
Estimated completion30 November 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Colon Adenocarcinoma or Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Percentage of Text Messages That Participants Responded to That Asked for a Reply Primary · 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%.

GroupValue95% CI
Text Message Intervention9690 – 98
Overall Median Score on the System Usability Scale (SUS) Primary · 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

GroupValue95% CI
Text Message Intervention72.565 – 85
Overall Score on the Acceptability of Intervention Measure (AIM) Primary · 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.

GroupValue95% CI
Text Message Intervention43 – 4.5
Overall Score on the Intervention Appropriateness Measure (IAM) Primary · 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.

GroupValue95% CI
Text Message Intervention43.4 – 4.9
Feasibility of Intervention Measure (FIM) Primary · 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.

GroupValue95% CI
Text Message Intervention43.8 – 4
Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ) Secondary · 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 grai

GroupValue95% CI
Text Message Intervention22.113.5 – 30.7
Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ) Secondary · 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

GroupValue95% CI
Text Message Intervention4.3± 9.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Text Message Intervention
Serious: 1/46 (2%)
Deaths: 0/46

Serious adverse events (1 terms)

ReactionSystemText Message Intervention
Syncope (Fainted)Nervous system disorders
Other adverse events (13 terms — click to expand)

ReactionSystemText Message Intervention
MyalgiaMusculoskeletal and connective tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
BloatingGastrointestinal disorders
FlatulenceGastrointestinal disorders
NauseaGastrointestinal disorders
ParesthesiaNervous system disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
HeartburnGastrointestinal disorders
DyspepsiaGastrointestinal disorders
DysphagiaGastrointestinal disorders
TinnitusEar and labyrinth disorders

Most-reported serious reactions: Syncope (Fainted).

Data from ClinicalTrials.gov NCT05746195 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Colon Adenocarcinoma

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05746195.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing