Clinical trial NCT01936636: Observational Registry Study of Quality of Life When Treating BTcP With Abstral
Official title: Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain With Freedom From Oral Discomfort Through the Use of Abstral® (Fentanyl) Sublingual Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Breakthrough Cancer Pain
Keywords: Breakthrough cancer pain
diary
quality of life
Abstral
BTcP
Lead sponsor: Galena Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-06
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quality of Life
timeFrame: One month
Secondary outcomes:
measure: Rapidity of BTcP
timeFrame: one month
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Physicians Pain Specialists of Alabama, P.C.
state: Alabama
city: Peoria
country: United States
facility: Pain Centers Nationwide
state: Arizona
city: Scottsdale
country: United States
facility: Valley Pain Consultants
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Pain Research
state: California
city: El Cajon
country: United States
facility: Navajo Road Pain Management Center
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence, Inc.
state: California
city: Irvine
country: United States
facility: Interventional Pain Management
state: California
city: Los Angeles
country: United States
facility: Alexander Ford, MD
state: California
city: Los Angeles
country: United States
facility: Cancer Care Institute
state: California
city: Los Angeles
country: United States
facility: Pete J. Ruane, MD, Inc.
state: California
city: Santa Monica
country: United States
facility: Pain Institute of Santa Monica
state: California
city: Woodland Hills
country: United States
facility: Randy Scharlach, MD
state: California
city: Golden
country: United States
facility: Red Rocks Center for Rehabilitation
state: Colorado
city: Danbury
country: United States
facility: Western Connecticut Health Network, Danbury Hospital
state: Connecticut
city: Stamford
country: United States
facility: Pain Management Associates of CT, PC
state: Connecticut
city: Plantation
country: United States
facility: Florida Cancer Care
state: Florida
city: Atlanta
country: United States
facility: Interventional Spine and Pain Management
state: Georgia
city: Newnan
country: United States
facility: Cancer Treatment Centers of America
state: Georgia
city: Overland Park
country: United States
facility: Pain Management Institute
state: Kansas
city: Bay City
country: United States
facility: Physiatry Consultants
state: Michigan
city: Brownstown
country: United States
facility: Michigan Interventional Pain Center
state: Michigan
city: Saginaw
country: United States
facility: Glenn Saperstein, D.O., LLC
state: Michigan
city: St. Clair Shores
country: United States
facility: Advanced Physical Medicine
state: Michigan
city: West Bloomfield
country: United States
facility: Michigan Spine & Pain
state: Michigan
city: New York
country: United States
facility: Fountain Medical Group
state: New York
city: New York
country: United States
facility: Upper East Side Pain Medicine, P.C.
state: New York
city: Syosset
country: United States
facility: Comprehensive Pain Management
state: New York
city: Williamsville
country: United States
facility: APWI
state: New York
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America
state: Oklahoma
city: New Castle
country: United States
facility: J. Fred Stoner, MD
state: Pennsylvania
city: Wind Gap
country: United States
facility: Progressive Pain Solutions
state: Pennsylvania
city: Providence
country: United States
facility: Jerrold Rosenberg, MD
state: Rhode Island
city: Germantown
country: United States
facility: The West Clinic Comprehensive Breast Center
state: Tennessee
city: Dallas
country: United States
facility: PRIDE
state: Texas
city: Kennewick
country: United States
facility: Columbia Basin Hematology & Oncology
state: Washington
Study officials:
References: