Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Nurse AMIE
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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 on active medical/radiation oncology treatment intervention clinical trials will be excluded, as they will already be having extensive symptom assessments. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse AMIE Supportive Care Intervention<br>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. | Behavioral: Nurse AMIE<br>* 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.<br>|
| Active Comparator: Usual Care<br>Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations. | Behavioral: Usual Care<br>* Binder of written supportive care materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supportive care, digital health, physical activity, symptom management