Clinical trial NCT05221606: Nurse AMIE (Addressing Malignancies in Individuals Everyday)
Official title: Nurse AMIE (Addressing Malignancies in Individuals Everyday)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: supportive care
digital health
physical activity
symptom management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: West Virginia University
name: Mount Nittany Medical Center
name: Penn State University
First posted: 2022-02-03
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: through study completion, an average of two years
Secondary outcomes:
measure: Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, month 6, month 12, month 18, month 24
measure: Change in Physical Function measured using the Short Physical Performance Battery (SPPB)
timeFrame: baseline, month 6, month 12, month 18, month 24
measure: Change in Symptoms measured using the Patient-Reported Outcomes Measurement Information System: The PROMIS ®-Preference (PROPr)
timeFrame: baseline, month 1, month 3, month 6, month 9, month 12, month 18, month 24
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: baseline
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month1
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 3
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 6
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 9
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 12
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 18
measure: Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
timeFrame: month 24
Other outcomes:
Locations:
city: Butler
country: United States
facility: UPMC-Butler
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC - Greenville
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Indiana
country: United States
facility: UPMC - Indiana
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC - New Castle
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC - Northwest
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Pittsburgh / UPMC
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: