search
Back to results

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

Primary Purpose

Colon Adenocarcinoma, Colorectal Carcinoma, Rectal Adenocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary intervention via Text Messaging
Survey Administration
Nutrition Education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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: 1. Does not meet any of the above inclusion criteria.

Sites / Locations

  • Zuckerberg San Francisco General
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Text message intervention

Arm Description

Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake. Participants will also complete semi-structured follow-up interviews and study related questionnaires.

Outcomes

Primary Outcome Measures

Median response rate to text messages
Participants' responses to text messages that ask for a response will be quantified using medians and interquartile range (IQR). The intervention will be determined feasible if the median response proportion to text messages that ask for a reply is >= 70%.
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.
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.
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.
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.

Secondary Outcome Measures

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
Change in mean total daily fiber intake (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 95% confidence intervals will be reported over time.

Full Information

First Posted
February 17, 2023
Last Updated
August 29, 2023
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05746195
Brief Title
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
Official Title
Use of Text Messages to Increase Whole Grain Consumption in Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenocarcinoma, Colorectal Carcinoma, Rectal Adenocarcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Text message intervention
Arm Type
Experimental
Arm Description
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake. Participants will also complete semi-structured follow-up interviews and study related questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention via Text Messaging
Intervention Description
Text messages will be sent to participants cell phones using the HealthySMS platform
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Various questionnaires evaluating participants dietary habits and use of study intervention will be administered
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Participants will receive nutrition education materials
Primary Outcome Measure Information:
Title
Median response rate to text messages
Description
Participants' responses to text messages that ask for a response will be quantified using medians and interquartile range (IQR). The intervention will be determined feasible if the median response proportion to text messages that ask for a reply is >= 70%.
Time Frame
Up to 12 weeks
Title
Overall median score on the System Usability Scale (SUS)
Description
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.
Time Frame
At 12 weeks
Title
Overall score on the Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
At 12 weeks
Title
Overall score on the Intervention Appropriateness Measure (IAM)
Description
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.
Time Frame
At 12 weeks
Title
Feasibility of Intervention Measure (FIM)
Description
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.
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Change in percent of grains that are whole reported on the Food Frequency Questionnaire (FFQ)
Description
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
Time Frame
Up to 12 weeks
Title
Change in mean total daily fiber intake (g/d) reported on the Food Frequency Questionnaire (FFQ)
Description
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 95% confidence intervals will be reported over time.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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: 1. Does not meet any of the above inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Steiding
Phone
(415) 514-6314
Email
Paige.Steiding@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Steiding
Phone
415-514-6314
Email
Paige.Steiding@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Steiding
Phone
415-514-6314
Email
Paige.Steiding@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs