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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00870 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| R21CA263539 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention via Text Messaging | Behavioral | Text messages will be sent to participants cell phones using the HealthySMS platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Does not meet any of the above inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Erin Van Blarigan, ScD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General | San Francisco | California | 94110 | United States | ||
| University of California, San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Message Intervention | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Message Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%. | Posted | Median | Inter-Quartile Range | percentage of text messages | Up to 12 weeks |
|
Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message Intervention | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope (Fainted) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Van Blarigan, ScD | University of California, San Francisco | (415) 476-1000 | Erin.VanBlarigan@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2023 | Nov 25, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2023 | Dec 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
|
| 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 |
| Up to 12 weeks |
| Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ) | 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. | Up to 12 weeks |
| San Francisco |
| California |
| 94143 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Two participants did not complete this survey at 12 weeks | Posted | Median | Inter-Quartile Range | score on a scale | At 12 weeks |
|
|
|
| Primary | 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. | Two participants did not complete this survey at 12 weeks | Posted | Median | Inter-Quartile Range | score on a scale | At 12 weeks |
|
|
|
| Primary | 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. | Two participants did not complete this survey at 12 weeks | Posted | Median | Inter-Quartile Range | scores on a scale | At 12 weeks |
|
|
|
| Primary | 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. | Two participants did not complete this survey at 12 weeks | Posted | Median | Inter-Quartile Range | scores on a scale | At 12 weeks |
|
|
|
| Secondary | Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ) | 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 | Two participants did not complete this survey at 12 weeks | Posted | Median | 95% Confidence Interval | percentage of grains consumed | Up to 12 weeks |
|
|
|
| Secondary | Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ) | 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. | Two participants did not complete this survey at 12 weeks | Posted | Mean | Standard Deviation | grams per day | Up to 12 weeks |
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| 40 |
| 46 |
| Bloating | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |