Observational Registry Study of Quality of Life When Treating BTcP With Abstral
RELIEF
Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain With Freedom From Oral Discomfort Through the Use of Abstral® (Fentanyl) Sublingual Tablets
1 other identifier
observational
164
1 country
36
Brief Summary
This Observational Registry study is designed to collect self-reported Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 5, 2015
November 1, 2015
1.7 years
September 2, 2013
November 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Primary: To compare self reported TIRF REMS Access-enrolled patient experience with BTcP at baseline (before using Abstral) to their experience after reaching a maintenance dose of Abstral * Characterize the effectiveness of treatment with Abstral in select pain and quality-of-life (QoL) domains * Abstral impact on pain interference with daily activities, somnolence, and oral health
One month
Secondary Outcomes (1)
Rapidity of BTcP
one month
Study Arms (1)
Cancer patients treated for BTcP
All patients 18 years of age and older with breakthrough cancer pain (BTcP) who are registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program and receiving Abstral® under the direction of a TIRF REMS Access program-registered physician are eligible for the study. Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may also use a proxy caregiver to assist in the completion of the study questionnaires.
Interventions
Eligibility Criteria
This observational Registry study is designed to collect self-reported TIRF REMS Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.
You may qualify if:
- All patients 18 years of age and older with breakthrough cancer pain who are registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program and receiving Abstral® under the direction of a TIRF REMS Access program-registered physician are eligible for the study.
- Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may also use a proxy caregiver to assist in the completion of the study questionnaires.
You may not qualify if:
- No patient can be enrolled who has not been prescribed Abstral for BTcP in compliance with Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program guidelines.
- No patient may be enrolled who has a contraindication to receiving Abstral or who is pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Physicians Pain Specialists of Alabama, P.C.
Mobile, Alabama, 36606, United States
Pain Centers Nationwide
Peoria, Arizona, 83582, United States
Valley Pain Consultants
Scottsdale, Arizona, 85254, United States
Coastal Pain Research
Carlsbad, California, 92009, United States
Navajo Road Pain Management Center
El Cajon, California, 92020, United States
California Cancer Associates for Research and Excellence, Inc.
Fresno, California, 93720, United States
Interventional Pain Management
Irvine, California, 92618, United States
Alexander Ford, MD
Los Angeles, California, 90035, United States
Cancer Care Institute
Los Angeles, California, 90036, United States
Pete J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Pain Institute of Santa Monica
Santa Monica, California, 90404, United States
Randy Scharlach, MD
Woodland Hills, California, 91367, United States
Red Rocks Center for Rehabilitation
Golden, Colorado, 80401, United States
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, 06810, United States
Pain Management Associates of CT, PC
Stamford, Connecticut, 06905, United States
Florida Cancer Care
Plantation, Florida, 33324, United States
Interventional Spine and Pain Management
Atlanta, Georgia, 30309, United States
Cancer Treatment Centers of America
Newnan, Georgia, 30265, United States
Pain Management Institute
Overland Park, Kansas, 66210, United States
Physiatry Consultants
Bay City, Michigan, 48796, United States
Michigan Interventional Pain Center
Brownstown, Michigan, 48183, United States
Glenn Saperstein, D.O., LLC
Saginaw, Michigan, 48604, United States
Advanced Physical Medicine
Saint Clair Shores, Michigan, 48080, United States
Michigan Spine & Pain
West Bloomfield, Michigan, 48322, United States
Fountain Medical Group
New York, New York, 10021, United States
Upper East Side Pain Medicine, P.C.
New York, New York, 36607, United States
Comprehensive Pain Management
Syosset, New York, 11791, United States
APWI
Williamsville, New York, 14221, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, United States
J. Fred Stoner, MD
New Castle, Pennsylvania, 16101, United States
Progressive Pain Solutions
Wind Gap, Pennsylvania, 18091, United States
Jerrold Rosenberg, MD
Providence, Rhode Island, 02904, United States
The West Clinic Comprehensive Breast Center
Germantown, Tennessee, 38138, United States
PRIDE
Dallas, Texas, 75235, United States
Columbia Basin Hematology & Oncology
Kennewick, Washington, 99336, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2013
First Posted
September 6, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 5, 2015
Record last verified: 2015-11