Nurse AMIE (Addressing Malignancies in Individuals Everyday)

March 4, 2024 updated by: Kathryn Schmitz, University of Pittsburgh
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Pennsylvania
      • Butler, Pennsylvania, United States, 16001
      • Greenville, Pennsylvania, United States, 16125
      • Hershey, Pennsylvania, United States, 17033
        • Active, not recruiting
        • Penn State Hershey Medical Center
      • Indiana, Pennsylvania, United States, 15701
      • New Castle, Pennsylvania, United States, 16105
      • Seneca, Pennsylvania, United States, 16346
      • State College, Pennsylvania, United States, 16803
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Usual Care
Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations.
Binder of written supportive care materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 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).
through study completion, an average of two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
Time Frame: 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.
baseline, month 6, month 12, month 18, month 24
Change in Physical Function measured using the Short Physical Performance Battery (SPPB)
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: baseline
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.
baseline
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month1
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.
month1
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month 3
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.
month 3
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month 6
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.
month 6
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month 9
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.
month 9
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month 12
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.
month 12
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: month 18
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.
month 18
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time Frame: 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.
month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kathryn Schmitz, PhD, University of Pittsburgh / UPMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2022

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY22090133
  • R01CA254659 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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