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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA254659 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| West Virginia University | OTHER |
| Mount Nittany Medical Center | UNKNOWN |
| Penn State University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Care | Active Comparator | Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Schmitz, PhD | University of Pittsburgh / UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC-Butler | Butler | Pennsylvania | 16001 | United States | ||
| UPMC - Greenville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286931 | Derived | 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. | |
| 40651555 | Derived | Schmitz 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2024 | Apr 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| OTHER |
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| Usual Care | Behavioral | Binder of written supportive care materials |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | month 24 |
| Greenville |
| Pennsylvania |
| 16125 |
| United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| UPMC - Indiana | Indiana | Pennsylvania | 15701 | United States |
| UPMC - New Castle | New Castle | Pennsylvania | 16105 | United States |
| UPMC - Northwest | Seneca | Pennsylvania | 16346 | United States |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |