Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Cancer Clinical Trial

Official title:

Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221606
• Other study ID #: STUDY22090133
• Secondary ID: R01CA254659
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Shawna E Doerksen, PhD
• Phone: 814-574-6833
• Email: doerksens[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 344
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Behavioral:
• Nurse AMIE
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.
• Usual Care
Binder of written supportive care materials

Locations

Country	Name	City	State
United States	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	West Virginia University	Morgantown	West Virginia
United States	UPMC - New Castle	New Castle	Pennsylvania
United States	UPMC - Northwest	Seneca	Pennsylvania
United States	Mount Nittany Medical Center	State College	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pittsburgh	Mount Nittany Medical Center, National Cancer Institute (NCI), Penn State University, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)	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
Secondary	Change in Physical Function measured using the Short Physical Performance Battery (SPPB)	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
Secondary	Change in Symptoms measured using the Patient-Reported Outcomes Measurement Information System: The PROMIS ®-Preference (PROPr)	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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
Secondary	Cost-Effectiveness measured using a self-report survey of Healthcare Utilization	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