Enhanced Usual Care for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tulane University, New Orleans, LACancer+1 MoreEnhanced Usual Care - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether an educational intervention can help patients with cancer understand and use palliative care, and feel better emotionally and physically.

Eligible Conditions
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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2
Multi-component oncofertility care intervention
1
Educational Materials
1
Enhanced Alert

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Follow-up at 14, 90, and 180 days

Follow-up at 14 days
Exploratory: Brief COPE Inventory
Day 180
Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions
Aim 3b: PROMIS Emotional Distress
Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical
Follow-up at 180 days
Exploratory: PROMIS Cognitive Function
Exploratory: PROMIS Emotional Support
Exploratory: PROMIS Meaning and Purpose
Exploratory: Quality of Life in Neurologic Disorders (Neuro-QoL) Concern with Death and Dying
Follow-up at 90 days
Exploratory: Medication Adherence
Exploratory: PROMIS Anger
Exploratory: PROMIS General Self-Efficacy
Exploratory: PROMIS Positive Affect
Exploratory: PROMIS Stress
Day 1
Aim 1: Palliative Care Knowledge Scale (PaCKS)
Aim 2a: Palliative Care Attitudes Scale (PCAS-9)
Up to 90 days
Aim 2b: Palliative Care Utilization

Trial Safety

Safety Progress

1 of 3

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Multi-component oncofertility care intervention
1
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Side Effects for

Arm 2: Enhanced Usual Care
13%Deceased - Unrelated to Study
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01325714) in the Arm 2: Enhanced Usual Care ARM group. Side effects include: Deceased - Unrelated to Study with 13%.

Trial Design

1 Treatment Group

Multimedia Psychoeducational Intervention + Enhanced Usual Care
1 of 1

Experimental Treatment

172 Total Participants · 1 Treatment Group

Primary Treatment: Enhanced Usual Care · No Placebo Group · N/A

Multimedia Psychoeducational Intervention + Enhanced Usual CareExperimental Group · 2 Interventions: Multimedia Psychoeducational Intervention, Enhanced Usual Care · Intervention Types: Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Usual Care
2010
Completed Phase 3
~9450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: follow-up at 14, 90, and 180 days

Who is running the clinical trial?

Tulane UniversityLead Sponsor
97 Previous Clinical Trials
215,491 Total Patients Enrolled
American Cancer Society, Inc.OTHER
213 Previous Clinical Trials
98,023 Total Patients Enrolled
University Medical Center-New OrleansUNKNOWN
2 Previous Clinical Trials
56 Total Patients Enrolled
Michael Hoerger, PhD, MSCRPrincipal Investigator - Tulane University
Tulane University

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced cancer that has spread to other parts of your body and cannot be treated with surgery. You have leukemia, lymphoma, multiple myeloma or have advanced heart, lung, kidney, or liver disease. You experience two or more severe symptoms like pain, tiredness, nausea, depression, or anxiety. You can understand and communicate in English, and receive medical care in southeast Louisiana.
References

Frequently Asked Questions

Is enrollment open for this clinical research endeavor?

"Clinicaltrials.gov records indicate that this medical investigation is currently accepting participants and was initially posted on March 31st 2021, with the latest edits made April 25th 2022." - Anonymous Online Contributor

Unverified Answer

How many participants have been included in the current research?

"Affirmative. According to information on clinicaltrials.gov, this study is currently looking for volunteers; it was initially posted on March 31st 2021 and its most recent update occurred April 25th 2022. The trial seeks 172 participants at two separate sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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