GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
16. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Annie W. Lin, PhD, RD
- Telefonnummer: (612) 356 2001
- E-post: awlin@umn.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence of Diet Tracking
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. juni 2030
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025LS135
- MNCCTN038 (Annen identifikator: Minnesota Clinical Trials Network (MNCCTN))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .