GastrointestinalNCT07661017
GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
A study testing Stool Sample and App Activity in people with Gastrointestinal and Mobile Health, run by Masonic Cancer Center, University of Minnesota.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Mobile Health, Gastrointestinal Symptoms
- What is being tested?
- Stool Sample and App Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Gastrointestinal, Mobile Health, Gastrointestinal Symptoms, Gut Health, Gastrointestinal Cancer, Survivorship
- Being tested
- Stool Sample, App Activity
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool SampleDiagnostic test
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.
App ActivityOther
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Personalization Level - No | Active comparator | 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. Receives: Diagnostic Test: Stool Sample; Other: App Activity |
| Personalization Level - Low | Active comparator | 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. Receives: Diagnostic Test: Stool Sample; Other: App Activity |
| Personalization Level - High | Active comparator | 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. Receives: Diagnostic Test: Stool Sample; Other: App Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence of Diet Tracking
Average count of days where the participant tracked at least two episodes a day.
Measured: 1 year
Adherence of Gastrointestinal (GI) Symptom and Stress Level Tracking
Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Clinical Trials Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661017
- Sponsor's protocol ID
- 2025LS135
- Other IDs
- MNCCTN038
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT07661017
- Acronym / sponsor ID
- 2025LS135
- Conditions
- Gastrointestinal, Mobile Health, Gastrointestinal Symptoms, Gut Health, Gastrointestinal Cancer, Survivorship
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Clinical Trials Network
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalization Level - No | Active comparator | Diagnostic Test: Stool Sample, Other: App ActivityThe "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. |
| Personalization Level - Low | Active comparator | Diagnostic Test: Stool Sample, Other: App ActivityThe "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. |
| Personalization Level - High | Active comparator | Diagnostic Test: Stool Sample, Other: App ActivityThe "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool SampleParticipants 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. | Diagnostic test | Personalization Level - High, Personalization Level - Low, Personalization Level - No |
| App ActivityParticipants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity. | Other | Personalization Level - High, Personalization Level - Low, Personalization Level - No |
Primary outcome
Adherence of Diet Tracking
Time frame: 1 year
Average count of days where the participant tracked at least two episodes a day.
Adherence of Gastrointestinal (GI) Symptom and Stress Level Tracking
Time frame: 1 year
Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Stool Sample and App Activity in people with Gastrointestinal and Mobile Health, run by Masonic Cancer Center, University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie W. Lin, PhD, RD ((612) 356 2001, awlin@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of Diet Tracking (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.