Observational Registry Study of Quality of Life When Treating BTcP With Abstral
NCT ID: NCT01936636
Last Updated: 2015-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
164 participants
OBSERVATIONAL
2013-10-31
2015-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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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.
Fentanyl
Interventions
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Fentanyl
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
No patient may be enrolled who has a contraindication to receiving Abstral or who is pregnant.
18 Years
ALL
No
Sponsors
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Galena Biopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Physicians Pain Specialists of Alabama, P.C.
Mobile, Alabama, United States
Pain Centers Nationwide
Peoria, Arizona, United States
Valley Pain Consultants
Scottsdale, Arizona, 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
Alexander Ford, MD
Los Angeles, California, United States
Cancer Care Institute
Los Angeles, California, United States
Pete J. Ruane, MD, Inc.
Los Angeles, California, United States
Pain Institute of Santa Monica
Santa Monica, California, United States
Randy Scharlach, MD
Woodland Hills, California, United States
Red Rocks Center for Rehabilitation
Golden, Colorado, United States
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, United States
Pain Management Associates of CT, PC
Stamford, Connecticut, United States
Florida Cancer Care
Plantation, Florida, United States
Interventional Spine and Pain Management
Atlanta, Georgia, United States
Cancer Treatment Centers of America
Newnan, Georgia, United States
Pain Management Institute
Overland Park, Kansas, United States
Physiatry Consultants
Bay City, Michigan, United States
Michigan Interventional Pain Center
Brownstown, Michigan, United States
Glenn Saperstein, D.O., LLC
Saginaw, Michigan, United States
Advanced Physical Medicine
Saint Clair Shores, Michigan, United States
Michigan Spine & Pain
West Bloomfield, Michigan, United States
Fountain Medical Group
New York, New York, United States
Upper East Side Pain Medicine, P.C.
New York, New York, United States
Comprehensive Pain Management
Syosset, New York, United States
APWI
Williamsville, New York, United States
Akron General Medical Center
Akron, Ohio, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 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
The West Clinic Comprehensive Breast Center
Germantown, Tennessee, United States
PRIDE
Dallas, Texas, United States
Columbia Basin Hematology & Oncology
Kennewick, Washington, United States
Countries
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Other Identifiers
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RELIEF
Identifier Type: -
Identifier Source: org_study_id
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