Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Not Applicable

Active, not recruiting

• Conditions: Cancer

• Registration Number: NCT05221606
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

After being informed about the details of the study, including risks and potential benefits, participants who give their informed consent will do baseline measurements. After these measures are collected, participants will be randomly assigned to either receive the computer tablet Nurse AMIE program or a supportive care book. Participants will be asked to complete measurements throughout the course of their active participation, which will last for 2 years.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-03
• Study Start: 2022-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

1. Patient receiving care for their cancer
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

1. 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).
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival	through study completion, an average of two years	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).

Secondary Outcome Measures

Name	Time	Method
Change in Physical Function measured using the Short Physical Performance Battery (SPPB)	baseline, month 6, month 12, month 18, month 24	The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands. Based on the time needed to complete the chair stands, a score is given. A summation of scores from all tests is taken, ranging from 0 -12. A higher score = Higher physical function.
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	month 24	This 14-item Healthcare Utilization survey asks participants to account for the healthcare services they used since a key date (provided to the participant). The services include primary care, surgical oncology, medical oncology, other specialists, infusion therapy, radiation therapy, imaging, lab tests, nursing home or rehab stays, hospice, home health care, or other specialty medical care. A high score indicates greater amount of health care services sought.
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	The PROMIS PROPr uses 14-items to measure 7 patient symptom domains (two items for each domain). The domains are as follows: cognition, depression, fatigue, pain, physical function, sleep disturbance, and social roles. Scores for each domain range from 1 to 5 on each item, with high scores indicative of full health.
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	The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions.

Trial Locations

Locations (8)

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