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Patient Self-management Program for Cancer (NU IMPACT Trial)

N/A
Waitlist Available
Led By David Cella, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.
medical chart confirmed diagnosis of advanced or metastatic solid or hematological malignancy;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cancer progression at 12 months
Awards & highlights

NU IMPACT Trial Summary

This trial is testing a new way to manage cancer symptoms that is more personalized and based on a person's needs.

Who is the study for?
This trial is for adults with a confirmed diagnosis of cancer, either solid or blood-related, who are undergoing non-curative treatment to manage their disease. Participants must be able to read English or Spanish and have started primary treatment within the last 3 months without severe mental health issues, dementia, or impairments that would prevent study participation.Check my eligibility
What is being tested?
The trial is evaluating an electronic symptom management program integrated with the health record system. It aims to improve quality of life by providing personalized monitoring and support based on each patient's unique needs and preferred language during their cancer treatment.See study design
What are the potential side effects?
Since this intervention involves self-management through an electronic program rather than medication, traditional side effects are not expected. However, there may be indirect effects related to engagement with technology such as screen fatigue.

NU IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have dementia, severe mental health issues, or impairments that would stop me from completing study tasks.
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My medical records confirm I have advanced or metastatic cancer.
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My medical records confirm I have cancer.
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I am receiving treatment to control or slow down my advanced cancer, not to cure it.
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I am 18 years old or older.

NU IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline treatment delivery satisfaction at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline treatment delivery satisfaction at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse symptom severity related to cancer and cancer treatment
Healthcare utilization by participant related to managing their cancer and cancer treatment
Individual-level change overtime related to cancer and cancer treatment symptoms
+1 more
Secondary outcome measures
Overall Survival (i.e., the time from study randomization until death due to any cause)
Patient clinical outcome of cancer progression (i.e., cancer has becomes worse)
Patient clinical outcome of cancer recurrence (i.e., cancer has come back)
+1 more

NU IMPACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced CareExperimental Treatment1 Intervention
Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention.
Group II: Usual CareActive Control1 Intervention
Patients will receive current standard care of EHR-integrated symptom monitoring.

Find a Location

Who is running the clinical trial?

Northwestern MedicineOTHER
10 Previous Clinical Trials
4,438 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
913,127 Total Patients Enrolled
Northwestern Memorial HealthCare (NMHC)UNKNOWN

Media Library

Patient Self-management Clinical Trial Eligibility Overview. Trial Name: NCT03988543 — N/A
Cancer Research Study Groups: Usual Care, Enhanced Care
Cancer Clinical Trial 2023: Patient Self-management Highlights & Side Effects. Trial Name: NCT03988543 — N/A
Patient Self-management 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988543 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key goals of this research project?

"This clinical trial will primarily measure healthcare utilisation related to cancer management and treatment satisfaction at 12 months, with secondary outcomes comprising of a second cancer diagnosis in curative intent, non-curative intent, and survivorship groups; cancer progression as observed via electronic health record codes for those in curative or non-curative treatments; and recurrence of the disease detected through patient medical records."

Answered by AI

How many participants are registering for this trial?

"Affirmative. Clinicaltrials.gov asserts that this research endeavour, which was announced on 28th September 2020, is actively seeking participants. The ongoing recruitment process seeks to find 12000 individuals from 1 specific medical centre."

Answered by AI

Are there still opportunities to participate in this trial?

"Affirmative. Clinicaltrials.gov reveals that this research is actively seeking participants. This trial was first posted on September 28th 2020 and had its last update on September 6th 2022, with 12000 patients needed to be enrolled at a single site."

Answered by AI
~912 spots leftby Apr 2025