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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
344
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.
Binder of written supportive care materials
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
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).
Time frame: through study completion, an average of two years
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.
Time frame: baseline, month 6, month 12, month 18, month 24
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.
Time frame: 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)
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.
Time frame: baseline, month 1, month 3, month 6, month 9, month 12, month 18, month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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.
Time frame: baseline
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.
Time frame: month1
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.
Time frame: month 3
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.
Time frame: month 6
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.
Time frame: month 9
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.
Time frame: month 12
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.
Time frame: month 18
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.
Time frame: month 24