CancerNCT05221606
Nurse AMIE (Addressing Malignancies in Individuals Everyday)
A study testing Nurse AMIE in people with Cancer, run by University of Pittsburgh at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nurse AMIE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 May 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UPMC-Butler
Butler, Pennsylvania, 16001
UPMC - Greenville
Greenville, Pennsylvania, 16125
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
UPMC - Indiana
Indiana, Pennsylvania, 15701
West Virginia University
Morgantown, West Virginia, 26506
UPMC - New Castle
New Castle, Pennsylvania, 16105
UPMC - Northwest
Seneca, Pennsylvania, 16346
Mount Nittany Medical Center
State College, Pennsylvania, 16803
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Nurse AMIE, Usual Care
- Keywords
- supportive care, digital health, physical activity, symptom management
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse AMIEBehavioural
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 CareBehavioural
Binder of written supportive care materials
| Study group | Role | What they receive |
|---|---|---|
| Nurse AMIE Supportive Care Intervention | Experimental | 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. Receives: Behavioral: Nurse AMIE |
| Usual Care | Active comparator | Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of two years
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start3 May 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), West Virginia University, Mount Nittany Medical Center, Penn State University
- Responsible party
- Principal investigator, Kathryn Schmitz, University of Pittsburgh
- Investigators
- Kathryn Schmitz, PhD, Principal investigator, University of Pittsburgh / UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221606
- Sponsor's protocol ID
- STUDY22090133
- Other IDs
- R01CA254659
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmitz KH, Baker S, Ahmed M, Celebre R, Patterson CG, Smith C, Werts-Pelter SJ, Stout N, Moss J, Calo WA, Sobolewski M, Doerksen SE. Worse Function and Symptoms Among the Most Rural Patients With Advanced Cancer: A Cross-Sectional Analysis. Cancer Med. 2026 Jun;15(6):e72033. doi: 10.1002/cam4.72033.
PubMed 42286931Schmitz KH, Baker S, Werts-Pelter SJ, Doerksen S, Patterson CG, Ahmed M, Scalise R, Vincent A, Desroches C, Sobolewski M, Celebre R, Garrett S, Stout N, Calo WA, Fisher S, Schleicher E, Gordon B, Kumar P. Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life. Contemp Clin Trials. 2025 Aug;155:108005. doi: 10.1016/j.cct.2025.108005. Epub 2025 Jul 10.
PubMed 40651555
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse AMIE (Addressing Malignancies in Individuals Everyday)
- ClinicalTrials.gov ID
- NCT05221606
- Acronym / sponsor ID
- STUDY22090133
- Conditions
- Cancer
- Keywords
- supportive care, digital health, physical activity, symptom management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), West Virginia University, Mount Nittany Medical Center, Penn State University
- Study start
- 3 May 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse AMIE Supportive Care Intervention | Experimental | Behavioral: Nurse AMIEParticipants 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. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants in the usual care arm will receive a book with some supportive care educational materials and recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse AMIESupportive 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. | Behavioural | Nurse AMIE Supportive Care Intervention |
| Usual CareBinder of written supportive care materials | Behavioural | Usual Care |
Primary outcome
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).
11 secondary outcomes
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
Change in Physical Function measured using the Short Physical Performance Battery (SPPB)
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)
Time frame: 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
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month1
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 3
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 6
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 9
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 12
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 18
Cost-Effectiveness measured using a self-report survey of Healthcare Utilization
Time frame: month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42286931Schmitz KH, Baker S, Ahmed M, Celebre R, Patterson CG, Smith C, Werts-Pelter SJ, Stout N, Moss J, Calo WA, Sobolewski M, Doerksen SE. Worse Function and Symptoms Among the Most Rural Patients With Advanced Cancer: A Cross-Sectional Analysis. Cancer Med. 2026 Jun;15(6):e72033. doi: 10.1002/cam4.72033.
- Derived from this study: PubMed 40651555Schmitz KH, Baker S, Werts-Pelter SJ, Doerksen S, Patterson CG, Ahmed M, Scalise R, Vincent A, Desroches C, Sobolewski M, Celebre R, Garrett S, Stout N, Calo WA, Fisher S, Schleicher E, Gordon B, Kumar P. Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life. Contemp Clin Trials. 2025 Aug;155:108005. doi: 10.1016/j.cct.2025.108005. Epub 2025 Jul 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Schmitz, PhD principal investigator
University of Pittsburgh / UPMC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse AMIE in people with Cancer, run by University of Pittsburgh at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: through study completion, an average of two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.