Colon Adenocarcinoma, Colorectal Carcinoma, Rectal Adenocarcinoma
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALDietary intervention via Text Messaging
Text messages will be sent to participants cell phones using the HealthySMS platform
OTHERSurvey Administration
Various questionnaires evaluating participants dietary habits and use of study intervention will be administered
BEHAVIORALNutrition Education
Participants will receive nutrition education materials
Sponsors
University of California, San Francisco
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Percentage of Text Messages That Participants Responded to That Asked for a Reply | 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%. |
| Overall Median Score on the System Usability Scale (SUS) | 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. |
| Overall Score on the Acceptability of Intervention Measure (AIM) | 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. |
| Overall Score on the Intervention Appropriateness Measure (IAM) | 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. |
| Feasibility of Intervention Measure (FIM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ) | 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 |
| Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErin Van Blarigan, ScD
University of California, San Francisco
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 30-39 years old | 2 Participants |
| Age, Customized 40-49 years old | 5 Participants |
| Age, Customized 50-59 years old | 12 Participants |
| Age, Customized 60-69 years old | 16 Participants |
| Age, Customized 70-79 years old | 8 Participants |
| Age, Customized 80-89 years old | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 40 / 46 |
| serious Total, serious adverse events | 1 / 46 |
Outcome results
None listed