Electronic Symptom Management for Advanced Cancer

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

344 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Nurse AMIE 3.0, a tablet-based program, to help stage 3 and 4 cancer patients in rural areas manage their symptoms. The program aims to provide remote support to improve their overall survival.

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 data supports the effectiveness of the treatment Nurse AMIE for advanced cancer?

Research shows that nurse practitioners, when involved in supportive interventions like home visits, can significantly improve pain control and quality of life for patients with advanced cancer. This suggests that treatments involving nurse-led care, like Nurse AMIE, may be effective in managing symptoms and improving patient outcomes. ^{1 2 3 4 5}

How is the Nurse AMIE treatment different from other treatments for advanced cancer?

Nurse AMIE is unique because it uses electronic systems to help manage symptoms in real-time for people with advanced cancer, allowing patients to report symptoms as they happen and receive timely interventions, which is especially useful for those in remote areas. ^{6 7 8 9 10}

Research Team

Kathryn Schmitz, PhD

Principal Investigator

University of Pittsburgh / UPMC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oncology nursing support for safe and effective use of eribulin in metastatic breast cancer. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Professional competencies of oncology nurses: Recognizing advanced practice in nursing. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Advanced breast cancer clinical nursing curriculum: review and recommendations. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Prediction and management of pain in patients with advanced cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Perceptions of the use of a remote monitoring system in patients receiving palliative care at home. [2017]

7. England 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. [2021]

8. Germany 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. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Quality of telephone nursing services for adults with cancer and related non-emergent visits to the emergency department. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Palliative care at the end of life. [2019]