Observational Registry Study of Quality of Life When Treating BTcP With Abstral

Quality of Life Clinical Trial

— RELIEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936636
• Other study ID #: RELIEF
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: November 3, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Galena Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Breakthrough Pain
• Quality of Life

Intervention

Drug:
• Fentanyl

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galena Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rapidity of BTcP	Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.	one month	No