Nurse AMIE (Addressing Malignancies in Individuals Everyday)
NCT ID: NCT05221606
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
344 participants
INTERVENTIONAL
2022-05-03
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Nurse AMIE Supportive Care Intervention
Participants in the intervention arm will receive the computer tablet with the Nurse AMIE program. Nurse AMIE will assess their symptoms daily and provide an intervention to help manage their symptoms.
Nurse AMIE
Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, mindfulness, CBT, DBT, soothing music.
Usual Care
Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations.
Usual Care
Binder of written supportive care materials
Interventions
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Nurse AMIE
Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, mindfulness, CBT, DBT, soothing music.
Usual Care
Binder of written supportive care materials
Eligibility Criteria
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Inclusion Criteria
2. Age: 18+ years of age
3. Has stage 3 or 4 cancer, or an unstaged cancer that is considered 'advanced' (greater than stage 2) by their treating oncologist
4. Must be within six months of initiation of pharmacologic or radiation treatment, for curative or palliative purposes, from a medical or radiation oncologist
5. Clinician-rated ECOG function of 0-3
6. Lives in a county with RUCC code 4 - 9 and/or zip code with RUCA code 4-10
7. Has access to personal device capable of receiving telephone calls for study facilitator check-ins
8. Fluent in written and spoken English
9. Sufficient vision/hearing to interact with the tablet and study staff
10. Clinician-defined life expectancy of 6 months or more
Exclusion Criteria
2. Patients who are participating in any other supportive care or behavioral intervention studies.
3. Non-English speaking patients will be excluded, as they represent less than 2% of the population targeted.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
West Virginia University
OTHER
Mount Nittany Medical Center
UNKNOWN
Penn State University
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Kathryn Schmitz
Professor
Principal Investigators
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Kathryn Schmitz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh / UPMC
Locations
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UPMC-Butler
Butler, Pennsylvania, United States
UPMC - Greenville
Greenville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC - Indiana
Indiana, Pennsylvania, United States
UPMC - New Castle
New Castle, Pennsylvania, United States
UPMC - Northwest
Seneca, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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Schmitz KH, Baker S, Werts-Pelter SJ, Doerksen S, Patterson CG, Ahmed M, Scalise R, Vincent A, Desroches C, Sobolewski M, Celebre R, Garrett S, Stout N, Calo WA, Fisher S, Schleicher E, Gordon B, Kumar P. Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life. Contemp Clin Trials. 2025 Aug;155:108005. doi: 10.1016/j.cct.2025.108005. Epub 2025 Jul 10.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY22090133
Identifier Type: -
Identifier Source: org_study_id
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