Electronic Symptom Management for Advanced Cancer

Not currently recruiting at 7 trial locations

Overseen By Sara M Garrett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Psychotic disorders, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of an electronic symptom management system called Nurse AMIE for people with advanced cancer living in rural areas. Participants will either use a tablet with Nurse AMIE, which checks symptoms daily and offers assistance, or receive a book with care tips. The goal is to determine if Nurse AMIE improves overall survival. Suitable candidates have stage 3 or 4 cancer, are currently receiving treatment, and reside in a rural area. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance cancer care for rural communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, as the trial focuses on managing symptoms electronically.

What prior data suggests that the Nurse AMIE system is safe for managing symptoms in advanced cancer patients?

Research shows that Nurse AMIE is a supportive care tool designed to help people with advanced cancer manage their symptoms. It uses a tablet to help patients track and manage their symptoms daily. This method is generally safe, as it supports patients through technology rather than new drugs or procedures.

Previous studies report that patients find this program easy to use and helpful for managing their symptoms. No major negative effects are linked to this type of electronic symptom management. Since Nurse AMIE focuses on managing symptoms without new medication, users receive it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse AMIE treatment because it offers a novel approach to managing symptoms for patients with advanced cancer. Unlike traditional methods that rely on periodic consultations and educational materials, Nurse AMIE provides daily symptom assessments through a computer tablet, allowing for timely and personalized interventions. This real-time, tech-enabled support could empower patients to better manage their symptoms and improve their quality of life.

What evidence suggests that Nurse AMIE is effective for managing symptoms in advanced cancer patients?

Research has shown that Nurse AMIE, which participants in this trial may receive, is a promising tool for helping people with advanced cancer manage their symptoms. This tablet-based platform aims to improve symptoms, quality of life, daily functioning, and overall survival. Studies have found that Nurse AMIE delivers high-quality care through technology, which is especially beneficial for those in rural areas. By regularly monitoring symptoms and offering solutions, Nurse AMIE helps patients manage their symptoms more effectively. This supportive care approach could lead to better outcomes for those with stage 3 and 4 cancer. Participants in the usual care arm will receive supportive care educational materials and recommendations. ^{1 2 3 4 6}

Who Is on the Research Team?

Kathryn Schmitz, PhD

Principal Investigator

University of Pittsburgh / UPMC

Are You a Good Fit for This Trial?

This trial is for adults with advanced stage 3 or 4 cancer, living in certain rural areas, who are undergoing treatment (not just palliative care). They must have a life expectancy of at least 6 months, be able to use a phone for check-ins, and not be part of other supportive care studies.

Inclusion Criteria

Clinician-defined life expectancy of 6 months or more

I am currently receiving treatment for my cancer.

My cancer is stage 3, 4, or considered advanced by my doctor.

Exclusion Criteria

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.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurements

Participants complete baseline measurements after informed consent

1-2 weeks

Treatment

Participants are randomly assigned to receive either the Nurse AMIE program or a supportive care book

2 years

Daily symptom assessment for Nurse AMIE group

Follow-up

Participants are monitored for survival and other outcomes after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Nurse AMIE
• Usual Care

Trial Overview Nurse AMIE is an electronic system designed to help manage symptoms in cancer patients. The study compares its effectiveness on survival rates against usual care without this technology among those living in rural settings.

How Is the Trial Designed?

Group I: Nurse AMIE Supportive Care Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Mount Nittany Medical Center

Collaborator

Trials

2

Recruited

1,400+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Published Research Related to This Trial

The advanced breast cancer clinical nurse (ABCCN) is designed to play a vital role in coordinating patient care and managing healthcare resources, ensuring that patients receive comprehensive support throughout their treatment journey.

The proposed curriculum for the ABCCN emphasizes clinical and psychosocial skills, conflict resolution, and teamwork, which are essential for optimizing patient care and resource utilization in advanced breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced breast cancer clinical nursing curriculum: review and recommendations. Vila, C., Reñones, C., Ferro, T., et al.[2018]

In a study involving patients with incurable cancer, those receiving intensive home visits from specially trained nurse practitioners experienced improved pain control in the last 90 days of life, enhancing their quality of life.

The findings suggest that emotional disturbance and expectations of control can predict pain issues in cancer patients, highlighting the importance of targeted supportive interventions in managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction and management of pain in patients with advanced cancer. McKegney, FP., Bailey, LR., Yates, JW.[2019]

A systematic review and meta-analysis of 19 studies involving web and mobile-based interventions showed that these e-Health tools significantly reduce physical symptom burden in adults with advanced cancer, with a standardized mean difference of -0.18.

Most interventions were delivered through web applications and were guided by symptom management theories, although many studies had a high risk of bias, indicating the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web and mobile-based symptom management interventions for physical symptoms of people with advanced cancer: A systematic review and meta-analysis. Saeidzadeh, S., Kamalumpundi, V., Chi, NC., et al.[2021]

The Advanced Symptom Management System in Palliative Care (ASyMSp) was tested in two rural communities in Scotland, demonstrating that mobile phone technology can effectively monitor and manage symptoms for patients in advanced stages of illness.

Both patients and healthcare professionals found the ASyMSp system to be usable and acceptable, suggesting it could enhance symptom management and improve quality of care in remote areas where face-to-face contact is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of the use of a remote monitoring system in patients receiving palliative care at home. McCall, K., Keen, J., Farrer, K., et al.[2017]

In a study of 29 nurses involved in cancer care at a tertiary hospital in Barcelona, 31% were identified as advanced practice nurses (APNs) meeting all competency standards, highlighting the presence of skilled professionals in oncology.

Most of the identified APNs had advanced degrees, with 24.1% holding a master's degree and 6.9% holding a PhD, emphasizing the need for recognizing and utilizing their competencies to improve patient care and optimize health resources in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional competencies of oncology nurses: Recognizing advanced practice in nursing. Muñoz-Villaverde, S., Martínez-García, M., Serrano-Oviedo, L., et al.[2023]

Patients and families desire ongoing prognostic information, but discussions about unfavorable prognoses often occur too late, limiting their ability to make informed decisions.

Advanced practice registered nurses can enhance communication about prognosis and end-of-life care, particularly by focusing on changes in functional status, which is a reliable indicator of disease progression in conditions like heart failure and chronic lung disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving End-of-Life Care Prognostic Discussions: Role of Advanced Practice Nurses. Kalowes, P.[2016]

Nurse practitioners are crucial in managing breast cancer, particularly in prevention, early detection, and treatment, emphasizing the importance of health assessments as part of their core competencies.

The review of five case studies shows that eribulin mesylate can be an effective treatment option for women with metastatic breast cancer who have previously undergone at least two chemotherapy regimens, highlighting its role in managing adverse events and improving therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology nursing support for safe and effective use of eribulin in metastatic breast cancer. Donovan, D., Urquhart, L., Hopkins, U., et al.[2021]

Effective symptom management is crucial in oncology nursing, significantly enhancing the quality of life for patients with advanced cancer and their families throughout the cancer journey.

Oncology nurses must conduct holistic assessments of patients' symptoms and care goals to create and evaluate personalized, evidence-based care plans that address individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care at the end of life. Lynch, MT.[2019]

In a study evaluating a remote symptom monitoring system for cancer treatment, alerts were triggered at a low incidence rate of 1.4%, primarily for symptoms like pain, fever, dyspnea, and nausea.

Healthcare professionals found the real-time management of these alerts to be highly relevant, with 95.1% agreeing on its clinical importance, and most alerts were effectively managed through nursing telephone consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time symptom management in the context of a remote symptom-monitoring system: prospective process evaluation and cross-sectional survey to explore clinical relevance. Coolbrandt, A., Muylaert, K., Vandeneede, E., et al.[2021]

A quality improvement project involving 77 cancer patients revealed that 91% of emergency department visits could have been avoided with better telephone assessments by nurses, indicating a significant gap in effective symptom management.

Only 38% of patients received adequate assessments over the phone, and very few were given medication reviews or self-care guidance, highlighting the need for improved training and protocols for telephone nursing in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of telephone nursing services for adults with cancer and related non-emergent visits to the emergency department. Stacey, D., Jolicoeur, L., Balchin, K., et al.[2020]

Citations

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Nurse AMIE randomized controlled trial to address ... Results from the Nurse AMIE trial will provide evidence of the efficacy of delivering a high-quality, technology-based supportive care program among underserved ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05221606

Nurse AMIE (Addressing Malignancies in Individuals ... Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life. Contemp ...

3. hsc.wvu.edu hsc.wvu.edu/research/grants/nurse-amie-addressing-malignancies-in-individuals-everyday-in-rural-pa-and-wv/

Nurse AMIE (Addressing Malignancies in Individuals ... Nurse AMIE is a tablet-based supportive care platform that aims to improve symptoms, quality of life, function and overall survival of adults with stage three ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001995/pdf?md5=f86f71bbb015448b1ab058bd43890216&pid=1-s2.0-S1551714425001995-main.pdf

Journal Pre-proof The Nurse AMIE trial is a 2-year, Phase III randomized controlled trial among 344 rural advanced cancer patients. Aim one of the trial is to ...

5. researchgate.net researchgate.net/publication/393650479_Nurse_AMIE_randomized_controlled_trial_to_address_symptom_management_among_rural_advanced_Cancer_patients_Addressing_malignancies_in_everyday_life

Nurse AMIE randomized controlled trial to address ... Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9868339/

Rationale and design of the nurse AMIE for Amazon Echo ... Nurse AMIE (Addressing Metastatic Individuals Everyday) is a technology based supportive care platform that provides guideline-concordant symptom management ...