Observational Registry Study of Quality of Life When Treating BTcP With Abstral
- Registration Number
- NCT01936636
- Lead Sponsor
- Galena Biopharma, Inc.
- 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.
- Detailed Description
This is a post-marketing, single arm, open label multicenter trial to assess Abstral (fentanyl) Sublingual Tablets for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients.
* Prior to study enrollment, patient enrollment in the TIRF REMS Access program must be confirmed.
* Eligible patients will sign written informed consent. Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may use a proxy caregiver to assist in the completion of the study questionnaires.
* Day 0, study site must enroll patient by completing a patient demographic profile (de-identified).
* Day 0, patient will be instructed how to use the questionnaires.
* Day 0, patient will complete the baseline questionnaire before leaving the physician office.
* On study Days 14, 21, and 28 (±3 days) patient questionnaire will be completed by patient (or caregiver proxy) via secure online data entry portal.
* For patients completing paper questionnaires, within 1 month of day 28, patient will return completed questionnaires via mail, fax or hand carried to the study site coordinator for processing.
* Patient will be considered to have completed the study successfully once all completed questionnaires have been received by the CRO within appropriate time limits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cancer patients treated for BTcP Fentanyl 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.
- Primary Outcome Measures
Name Time Method Quality of Life One month 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
- Secondary Outcome Measures
Name Time Method Rapidity of BTcP one month Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.
Trial Locations
- Locations (35)
Florida Cancer Care
🇺🇸Plantation, Florida, United States
Coastal Pain Research
🇺🇸Carlsbad, California, United States
Navajo Road Pain Management Center
🇺🇸El Cajon, California, United States
California Cancer Associates for Research and Excellence, Inc.
🇺🇸Fresno, California, United States
Interventional Pain Management
🇺🇸Irvine, California, United States
Cancer Care Institute
🇺🇸Los Angeles, California, United States
Pete J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States
Interventional Spine and Pain Management
🇺🇸Atlanta, Georgia, United States
Pain Management Institute
🇺🇸Overland Park, Kansas, United States
Glenn Saperstein, D.O., LLC
🇺🇸Saginaw, Michigan, United States
Physiatry Consultants
🇺🇸Bay City, Michigan, United States
Fountain Medical Group
🇺🇸New York, New York, United States
Michigan Spine & Pain
🇺🇸West Bloomfield, Michigan, United States
Upper East Side Pain Medicine, P.C.
🇺🇸New York, New York, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
APWI
🇺🇸Williamsville, New York, United States
J. Fred Stoner, MD
🇺🇸New Castle, Pennsylvania, United States
Progressive Pain Solutions
🇺🇸Wind Gap, Pennsylvania, United States
Jerrold Rosenberg, MD
🇺🇸Providence, Rhode Island, United States
PRIDE
🇺🇸Dallas, Texas, United States
Columbia Basin Hematology & Oncology
🇺🇸Kennewick, Washington, United States
Pain Centers Nationwide
🇺🇸Peoria, Arizona, United States
Valley Pain Consultants
🇺🇸Scottsdale, Arizona, United States
Western Connecticut Health Network, Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Pain Management Associates of CT, PC
🇺🇸Stamford, Connecticut, United States
Advanced Physical Medicine
🇺🇸St. Clair Shores, Michigan, United States
Michigan Interventional Pain Center
🇺🇸Brownstown, Michigan, United States
The West Clinic Comprehensive Breast Center
🇺🇸Germantown, Tennessee, United States
Physicians Pain Specialists of Alabama, P.C.
🇺🇸Mobile, Alabama, United States
Alexander Ford, MD
🇺🇸Los Angeles, California, United States
Randy Scharlach, MD
🇺🇸Woodland Hills, California, United States
Pain Institute of Santa Monica
🇺🇸Santa Monica, California, United States
Cancer Treatment Centers of America
🇺🇸Tulsa, Oklahoma, United States
Comprehensive Pain Management
🇺🇸Syosset, New York, United States
Red Rocks Center for Rehabilitation
🇺🇸Golden, Colorado, United States