Gastrointestinal, Gastrointestinal Cancer, Gastrointestinal Symptoms, GI Cancer, Gut Health, Mobile Health, Survivorship
Conditions
Brief 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 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.
Interventions
DIAGNOSTIC_TESTStool 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.
OTHERApp Activity
Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.
Sponsors
Masonic Cancer Center, University of Minnesota
Minnesota Clinical Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence of Diet Tracking | 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 | 1 year | Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both). |
Contacts
CONTACTAnnie W. Lin, PhD, RD
Outcome results
None listed