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Active, Not Recruiting

NCT Number: NCT05221606

Nurse AMIE (Addressing Malignancies in Individuals Everyday)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC-Butler, Butler, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse AMIE

Behavioral

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

Behavioral

Binder of written supportive care materials

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Mount Nittany Medical Center
  • National Cancer Institute (NCI)
  • Penn State University
  • West Virginia University

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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