Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT04616768
Eligibility Criteria:
Inclusion Criteria:
1. English-speaking
2. Have a diagnosis of incurable or Stage IV lung or gastrointestinal cancer
3. Receive primary oncology care with a thoracic or gastrointestinal medical oncology specialist at the Perelman Center for Advanced Medicine (i.e. does not have a local oncologist that provides cancer care, including other UPHS clinic sites)
4. Currently receiving or planned receipt within 2 weeks of IV chemotherapy (see exclusions below)
5. The patient has a smart phone that can receive SMS text messages and has blue-tooth capability that can connect to Fitbit.
Exclusion Criteria:
1. Age \< 18 years
2. Patients has used a wheelchair, been bedbound or is unable to walk without assistance from other people every day for the past 7 days (patients are not excluded for the use of walkers or canes)
3. Patients who are receiving checkpoint inhibitor monotherapy or oral tyrosine kinase inhibitors
4. Patients who receive chemotherapy infusions at another UPHS site or outside of UPHS or whose primary oncologist is not in thoracic or gastrointestinal oncology groups at PCAM. Notably, patients who receive part of their chemotherapy regimen at home will still be allowed to enroll.
5. Lung cancer patients enrolled in an ongoing palliative care clinical trial that may lead to better communication regarding symptoms and functional status.
6. Clinician concerns about behavioral health issues that may prevent engagement with text message prompts
7. Are enrolled in another interventional clinical trial (as clinical trials often have a substantial symptom-reporting structure; non-interventional clinical trials are permitted e.g. trials that just involve blood tests)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04616768
Study Brief:
Protocol Section:
NCT04616768