GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer
16 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Annie W. Lin, PhD, RD
- Número de telefone: (612) 356 2001
- E-mail: awlin@umn.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Comparador Ativo: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence of Diet Tracking
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de dezembro de 2026
Conclusão Primária (Estimado)
1 de junho de 2029
Conclusão do estudo (Estimado)
1 de junho de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
16 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de junho de 2026
Primeira postagem (Real)
22 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025LS135
- MNCCTN038 (Outro identificador: Minnesota Clinical Trials Network (MNCCTN))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .