What side effects are associated with this type of intervention?

Common treatments for advanced-stage cancers, such as those studied in the Nurse AMIE 3.0 trial, include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy often causes fatigue, nausea, vomiting, hair loss, anemia, and increased infection risk. Radiation therapy can lead to skin irritation, fatigue, and localized pain. Targeted therapies, like CDK 4/6 inhibitors, may result in neutropenia, diarrhea, and elevated creatinine levels. These side effects necessitate careful management to maintain patient quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving symptom management and patient monitoring in cancer care. For instance, pembrolizumab and ipilimumab are approved for advanced melanoma, focusing on immune-related adverse events and their management. Additionally, reflexology and acupuncture have been studied for symptom control in cancer patients, although they are not FDA-approved treatments. The Nurse AMIE 3.0 trial's focus on electronic symptom management aligns with the broader trend of integrating supportive care measures to enhance the quality of life for cancer patients.

What other types of research exist?

Promising alternatives to Nurse AMIE 3.0 for cancer patients in 2024 include: 1) Remote Patient Monitoring (RPM) programs, which have shown to reduce hospitalizations in cancer patients with COVID-19. 2) Telemedicine systems, such as WeChat-based telemedicine, which have been effective in monitoring and managing home-quarantined patients with COVID-19. 3) Automated Text Messaging Services for monitoring patients at home, which have demonstrated effectiveness in managing COVID-19 symptoms. These technologies offer robust platforms for continuous patient monitoring and symptom management.

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Behavioral Intervention

Electronic Symptom Management for Advanced Cancer

N/A

Recruiting

Led By Kathryn Schmitz, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of two years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since Nurse AMIE is a symptom management system rather than a drug, it doesn't have traditional side effects. However, there may be issues related to the usability or accessibility of the technology that could affect patient experience.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival

Secondary study objectives

Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)

Change in Physical Function measured using the Short Physical Performance Battery (SPPB)

Change in Symptoms measured using the Patient-Reported Outcomes Measurement Information System: The PROMIS ®-Preference (PROPr)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nurse AMIE Supportive Care InterventionExperimental Treatment1 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 CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nurse AMIE

2017

N/A

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy works by targeting rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, causing them to die or stop dividing. Targeted therapies focus on specific molecules involved in cancer growth and progression, minimizing damage to normal cells. These treatments are crucial for cancer patients as they aim to control or eliminate cancer, but they also come with significant side effects. Effective symptom management systems, like the one studied in Nurse AMIE 3.0, are essential to monitor and alleviate these side effects, improving patients' quality of life and treatment adherence.

Usefulness and Safety Evaluation of Chemotherapy Administration Device for Nurses: Experimental Study.Application of Information Technology to Clinical Trial Evaluation and Enrollment: A Review.Collaborative network to take responsibility for oral anticancer therapy (CONTACT): Study-protocol investigating the impact of a care pathway.