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GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer

16 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Annie W. Lin, PhD, RD
  • Numero di telefono: (612) 356 2001
  • Email: awlin@umn.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Test diagnostico: Stool Sample
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.
Altro: App Activity
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.
Comparatore attivo: 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.
Test diagnostico: Stool Sample
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.
Altro: App Activity
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.
Comparatore attivo: 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.
Test diagnostico: Stool Sample
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.
Altro: App Activity
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence of Diet Tracking
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaboratori

Minnesota Clinical Trials Network

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025LS135
  • MNCCTN038 (Altro identificatore: Minnesota Clinical Trials Network (MNCCTN))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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