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

Quality of Life Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Breakthrough Pain
• Quality of Life

• NCT number: NCT01936636
• Study type: Observational [Patient Registry]
• Source: Galena Biopharma, Inc.
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: June 2015