- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221606
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
Intervention / Treatment
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
- Name: Shawna E Doerksen, PhD
- Phone Number: 814-574-6833
- Email: doerksens@upmc.edu
Study Contact Backup
- Name: Sara M Garrett, PhD
- Email: garrettsm@upmc.edu
Study Locations
-
-
Pennsylvania
-
Butler, Pennsylvania, United States, 16001
- Recruiting
- UPMC-Butler
-
Contact:
- Kathryn Schmitz, PhD
- Phone Number: 412-623-6216
- Email: schmitzk@upmc.edu
-
Contact:
- Shawna Doerksen, PhD
- Email: doerksens@upmc.edu
-
Greenville, Pennsylvania, United States, 16125
- Recruiting
- UPMC - Greenville
-
Contact:
- Kathryn Schmitz, PhD
- Phone Number: 412-623-6216
- Email: schmitzk@upmc.edu
-
Contact:
- Shawna Doerksen, PhD
- Email: doerksens@upmc.edu
-
Hershey, Pennsylvania, United States, 17033
- Active, not recruiting
- Penn State Hershey Medical Center
-
Indiana, Pennsylvania, United States, 15701
- Recruiting
- UPMC - Indiana
-
Contact:
- Kathryn Schmitz, PhD
- Phone Number: 412-623-6216
- Email: schmitzk@upmc.edu
-
Contact:
- Shawna Doerksen, PhD
- Email: doerksens@upmc.edu
-
New Castle, Pennsylvania, United States, 16105
- Recruiting
- UPMC - New Castle
-
Contact:
- Kathryn Schmitz, PhD
- Phone Number: 412-623-6216
- Email: schmitzk@upmc.edu
-
Contact:
- Shawna Doerksen, PhD
- Email: doerksens@upmc.edu
-
Seneca, Pennsylvania, United States, 16346
- Recruiting
- UPMC - Northwest
-
Contact:
- Kathryn Schmitz, PhD
- Phone Number: 412-623-6216
- Email: schmitzk@upmc.edu
-
Contact:
- Shawna Doerksen, PhD
- Email: doerksens@upmc.edu
-
State College, Pennsylvania, United States, 16803
- Recruiting
- Mount Nittany Medical Center
-
Contact:
- Shannon Fisher
- Email: sfisher@mountnittany.org
-
-
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:
- 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
Exclusion Criteria:
- 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.
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.
Sponsor
Collaborators
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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