GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
2026年6月16日 更新者:Masonic Cancer Center, University of Minnesota
There are two components to the study: a patient and a clinician study.
The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions.
The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention.
It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases.
During active phases, participants will be asked to use the GutCheck app every day.
Prior to the first active phase, participants will go through informed consent and app training.
The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress.
The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms.
Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit.
The second active phase will last four weeks and will involve the message intervention.
A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day.
Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.
研究概览
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Annie W. Lin, PhD, RD
- 电话号码:(612) 356 2001
- 邮箱:awlin@umn.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion
Survivors of GI cancer are eligible if they are:
- ≥18 years old
- reside in or have received cancer care in Minnesota
- own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).
- are English-speaking
- have received a GI cancer diagnosis (e.g., esophageal, gastric, colorectal, liver, pancreatic, etc)
- At least 2 months post-cancer treatment
Inclusion criteria for oncology specialists (oncologists, advanced practice providers, nurses, dietitians, and patient navigators) include:
- Have interacted with at least 1 cancer patient or survivor in the past month.
- Have experience working with electronic health records (EHR).
Exclusion
- Currently pregnant (Patient Study ONLY)
- Pregnancy status may be self-reported by the participant.
- Individuals who are postmenopausal, surgically sterile, or otherwise unable to become pregnant are not subject to this exclusion.
- Active cancer or receiving treatment for another cancer.
- Currently taking or has taken antibiotics in the last 3 months.
- Diagnosis of inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis), and/or celiac disease.
- Involuntary weight loss of 10% or more of usual body weight within 6 months, or involuntary loss of 5% or more of usual body weight in 1 month.
Oncology specialists' exclusion criteria include:
- Unable to participate in an interview
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Personalization Level - No
The "no personalization" group will receive generic push messages based on United States Department of Agriculture and Centers for Disease Control and Prevention recommendations.
Within their personalization level, participants will be automatically randomized daily to varying message frequency (one vs. three times per day) and timing (preferred times vs. established times).
After each message, all participants will be asked to evaluate whether the message was useful using a 3-point Likert-type visual scale in the app.
|
Participants who were selected to collect their stool samples will be mailed their second kit before the last week (week 8) of intervention.
Participants will collect their stool sample during week 8 and mail them to be processed prior to the Exit Interview Visit.
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily.
They will also track physical activity.
|
|
有源比较器:Personalization Level - Low
The "low personalization" group will receive similar messages, with occasional use of their names and references to GI cancer.
Within their personalization level, participants will be automatically randomized daily to varying message frequency (one vs. three times per day) and timing (preferred times vs. established times).
After each message, all participants will be asked to evaluate whether the message was useful using a 3-point Likert-type visual scale in the app.
|
Participants who were selected to collect their stool samples will be mailed their second kit before the last week (week 8) of intervention.
Participants will collect their stool sample during week 8 and mail them to be processed prior to the Exit Interview Visit.
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily.
They will also track physical activity.
|
|
有源比较器:Personalization Level - High
The "high personalization" group messages will be further tailored to age and gender to provide social comparisons.
This group will receive food-related GI messages based on their responses from the personalization quiz during Week 1. Messages will emphasize affordable, commonly available foods to increase likelihood of accessibility.
Within their personalization level, participants will be automatically randomized daily to varying message frequency (one vs. three times per day) and timing (preferred times vs. established times).
After each message, all participants will be asked to evaluate whether the message was useful using a 3-point Likert-type visual scale in the app.
|
Participants who were selected to collect their stool samples will be mailed their second kit before the last week (week 8) of intervention.
Participants will collect their stool sample during week 8 and mail them to be processed prior to the Exit Interview Visit.
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily.
They will also track physical activity.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence of Diet Tracking
大体时间:1 year
|
Average count of days where the participant tracked at least two episodes a day.
|
1 year
|
|
Adherence of Gastrointestinal (GI) Symptom and Stress Level Tracking
大体时间:1 year
|
Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both).
|
1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2029年6月1日
研究完成 (估计的)
2030年6月1日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.