GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
16 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Annie W. Lin, PhD, RD
- Numéro de téléphone: (612) 356 2001
- E-mail: awlin@umn.edu
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence of Diet Tracking
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
1 juin 2029
Achèvement de l'étude (Estimé)
1 juin 2030
Dates d'inscription aux études
Première soumission
16 juin 2026
Première soumission répondant aux critères de contrôle qualité
16 juin 2026
Première publication (Réel)
22 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025LS135
- MNCCTN038 (Autre identifiant: Minnesota Clinical Trials Network (MNCCTN))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .