Nurse AMIE (Addressing Malignancies in Individuals Everyday)

NCT05221606 | Active Not Recruiting DMC

• 2 other identifiers: STUDY22090133R01CA254659
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 8

Brief Summary

Nurse AMIE 3.0 is testing the effectiveness of an electronic symptom management system on overall survival in people with stage 3 and 4 cancer who live in rural areas.

Conditions

Cancer

Keywords

supportive care; digital health; physical activity; symptom management

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival of each participant will be monitored through the electronic medical records throughout the course of the study. After the study is completed, we will monitor survival using the National Death Index from the Centers for Disease Control and Prevention (CDC).

  through study completion, an average of two years

Secondary Outcomes (11)

• Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)

  baseline, month 6, month 12, month 18, month 24

• Change in Physical Function measured using the Short Physical Performance Battery (SPPB)

  baseline, month 6, month 12, month 18, month 24

• Change in Symptoms measured using the Patient-Reported Outcomes Measurement Information System: The PROMIS ®-Preference (PROPr)

  baseline, month 1, month 3, month 6, month 9, month 12, month 18, month 24

• Cost-Effectiveness measured using a self-report survey of Healthcare Utilization

  baseline

• Cost-Effectiveness measured using a self-report survey of Healthcare Utilization

  month1

Study Arms (2)

Nurse AMIE Supportive Care Intervention

EXPERIMENTAL

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.

Behavioral: Nurse AMIE

Usual Care

ACTIVE COMPARATOR

Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations.

Behavioral: Usual Care

Interventions

Nurse AMIE BEHAVIORAL

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.

Nurse AMIE Supportive Care Intervention

Usual Care BEHAVIORAL

Binder of written supportive care materials

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient receiving care for their cancer
• Age: 18+ years of age
• Has stage 3 or 4 cancer, or an unstaged cancer that is considered 'advanced' (greater than stage 2) by their treating oncologist
• Must be within six months of initiation of pharmacologic or radiation treatment, for curative or palliative purposes, from a medical or radiation oncologist
• Clinician-rated ECOG function of 0-3
• Lives in a county with RUCC code 4 - 9 and/or zip code with RUCA code 4-10
• Has access to personal device capable of receiving telephone calls for study facilitator check-ins
• Fluent in written and spoken English
• Sufficient vision/hearing to interact with the tablet and study staff
• Clinician-defined life expectancy of 6 months or more

You may not qualify if:

• Patients with medical or psychiatric conditions documented in the medical record (beyond cancer, its treatments, and its symptoms) that would impair our ability to test study hypotheses (e.g. psychotic disorders, dementia, inability to give informed consent, or follow study instructions).
• Patients who are participating in any other supportive care or behavioral intervention studies.
• Non-English speaking patients will be excluded, as they represent less than 2% of the population targeted.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator
• West Virginia University: collaborator
• Mount Nittany Medical Center: collaborator
• Penn State University: collaborator

Study Sites (8)

UPMC-Butler

Butler, Pennsylvania, 16001, United States

Location

UPMC - Greenville

Greenville, Pennsylvania, 16125, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UPMC - Indiana

Indiana, Pennsylvania, 15701, United States

Location

UPMC - New Castle

New Castle, Pennsylvania, 16105, United States

Location

UPMC - Northwest

Seneca, Pennsylvania, 16346, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 40651555 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kathryn Schmitz, PhD

  University of Pittsburgh / UPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 3, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)