Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Ad… (NCT05038254) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
United States750 participantsStarted 2021-05-12
Plain-language summary
This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (≥ 18 years)
* English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
* Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only)
* Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion.
* Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents.
Exclusion Criteria:
* Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements.
* Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on reducing emergency room visits and unplanned hospitalizations caused by chemotherapy side effects — could this kind of enhanced outpatient symptom management program actually change how my side effects are monitored and treated between my scheduled appointments?
2Since this study is listed as 'active but not recruiting,' does that mean enrollment is already closed, and if so, are there similar symptom management programs at this facility I could still access while I'm on chemotherapy?
3The trial covers a wide range of Stage IV GI cancers including my specific diagnosis — based on what they've been testing, what kinds of outpatient support or interventions have been shown to help patients avoid unnecessary ER visits during treatment?
4Because this is listed as Phase NA rather than a traditional Phase I, II, or III drug trial, does that mean it's more of a care delivery or process study, and would participating have changed my actual chemotherapy regimen or just how symptoms are managed around it?
5If this type of enhanced symptom monitoring program isn't available to me right now, what does my current care team already have in place to help me manage serious side effects at home and know when I truly need to go to the emergency room?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.