Quality-of-Life Assessment for Metastatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Cancer+8 MoreQuality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying two different methods of delivering the ENABLE palliative care program to patients with advanced cancer and their caregivers. The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management.

Eligible Conditions
  • Metastatic Cancer
  • Physician Assistant
  • Caregiver
  • Oncologist
  • Nurse
  • Progressive Cancer
  • Cancer
  • Recurrent Malignant Solid Tumor
  • Nurse Practitioner

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At 24 weeks

At 24 weeks
Caregiver mood, using the Hospital Anxiety and Depression Scale (HADS).
Caregiver quality of life, Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health
Patient mood, measured by the Hospital Anxiety and Depression Scale (HADS)
Patient quality of life, assessed using the FACIT-Pal.
Up to 24 weeks
Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program
Practice completion of the implementation strategy (either Virtual Learning Collaborative [VLC] or Technical Assistance [TA]) and all associated implementation measures

Trial Safety

Side Effects for

Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
48%Blood or bone marrow
42%Metabolic or laboratory-testing result
40%Hepatic
36%General
28%Constitutional symptoms
26%Neurologic
22%Pulmonary
21%Gastrointestinal
19%Renal or genitourinary
19%Arrhythmia
13%Pain
8%Infection or febrile neutropenia
7%Skin
7%Musculoskeletal
2%Death
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT00019682) in the Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) ARM group. Side effects include: Blood or bone marrow with 48%, Metabolic or laboratory-testing result with 42%, Hepatic with 40%, General with 36%, Constitutional symptoms with 28%.

Trial Design

2 Treatment Groups

Group II (ENABLE palliative care program, phone calls, TA)
1 of 2
Group I (ENABLE palliative care program, phone calls, VLC)
1 of 2

Experimental Treatment

840 Total Participants · 2 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · N/A

Group II (ENABLE palliative care program, phone calls, TA)Experimental Group · 6 Interventions: Quality-of-Life Assessment, Behavioral, Psychological or Informational Intervention, Survey Administration, Medical Examination, Telephone-Based Intervention, Educational Intervention · Intervention Types: Other, Other, Other, Procedure, Behavioral, Other
Group I (ENABLE palliative care program, phone calls, VLC)Experimental Group · 6 Interventions: Quality-of-Life Assessment, Behavioral, Psychological or Informational Intervention, Survey Administration, Medical Examination, Telephone-Based Intervention, Educational Intervention · Intervention Types: Other, Other, Other, Procedure, Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Examination
2016
N/A
~140
Telephone-Based Intervention
2018
Completed Phase 2
~3250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 weeks

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,435 Previous Clinical Trials
2,228,394 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,140,671 Total Patients Enrolled
University of Rochester NCORP Research BaseLead Sponsor
11 Previous Clinical Trials
7,245 Total Patients Enrolled
Lisa Zubkoff, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The ENABLE Nurse Coach Program is a one-year study that will evaluate the effectiveness of a nurse coach program for improving the quality of care for older adults with chronic conditions.
You are a nurse and you are committed to palliative care.
The ENABLE implementation team at each participating practice will include at least the ENABLE nurse coach(es) and a coordinator.
You are a nurse or an advanced practice provider with experience in oncology or palliative care.
You are a licensed nurse who has a minimum of two years experience caring for patients with cancer in either an oncology or palliative care setting.