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Trial Title:
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
NCT ID:
NCT05746195
Condition:
Colon Adenocarcinoma
Colorectal Carcinoma
Rectal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Colorectal Neoplasms
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Dietary intervention via Text Messaging
Description:
Text messages will be sent to participants cell phones using the HealthySMS platform
Arm group label:
Text message intervention
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Various questionnaires evaluating participants dietary habits and use of study
intervention will be administered
Arm group label:
Text message intervention
Intervention type:
Behavioral
Intervention name:
Nutrition Education
Description:
Participants will receive nutrition education materials
Arm group label:
Text message intervention
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuckerberg San Francisco General
Address:
City:
San Francisco
Zip:
94110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paige Steiding
Phone:
415-514-6314
Email:
Paige.Steiding@ucsf.edu
Investigator:
Last name:
Erin Van Blarigan, ScD
Email:
Principal Investigator
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paige Steiding
Phone:
415-514-6314
Email:
Paige.Steiding@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Erin Van Blarigan, ScD
Email:
Principal Investigator
Start date:
November 3, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746195
