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

Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain With Freedom From Oral Discomfort Through the Use of Abstral® (Fentanyl) Sublingual Tablets

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breakthrough Cancer Pain
• Intervention / Treatment: Drug: Fentanyl

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.

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36606
      • Physicians Pain Specialists of Alabama, P.C.
  • Arizona
    • Peoria, Arizona, United States, 83582
      • Pain Centers Nationwide
    • Scottsdale, Arizona, United States, 85254
      • Valley Pain Consultants
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain Research
    • El Cajon, California, United States, 92020
      • Navajo Road Pain Management Center
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence, Inc.
    • Irvine, California, United States, 92618
      • Interventional Pain Management
    • Los Angeles, California, United States, 90035
      • Alexander Ford, MD
    • Los Angeles, California, United States, 90036
      • Cancer Care Institute
    • Los Angeles, California, United States, 90036
      • Pete J. Ruane, MD, Inc.
    • Santa Monica, California, United States, 90404
      • Pain Institute of Santa Monica
    • Woodland Hills, California, United States, 91367
      • Randy Scharlach, MD
  • Colorado
    • Golden, Colorado, United States, 80401
      • Red Rocks Center for Rehabilitation
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network, Danbury Hospital
    • Stamford, Connecticut, United States, 06905
      • Pain Management Associates of CT, PC
  • Florida
    • Plantation, Florida, United States, 33324
      • Florida Cancer Care
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Interventional Spine and Pain Management
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Pain Management Institute
  • Michigan
    • Bay City, Michigan, United States, 48796
      • Physiatry Consultants
    • Brownstown, Michigan, United States, 48183
      • Michigan Interventional Pain Center
    • Saginaw, Michigan, United States, 48604
      • Glenn Saperstein, D.O., LLC
    • St. Clair Shores, Michigan, United States, 48080
      • Advanced Physical Medicine
    • West Bloomfield, Michigan, United States, 48322
      • Michigan Spine & Pain
  • New York
    • New York, New York, United States, 10021
      • Fountain Medical Group
    • New York, New York, United States, 36607
      • Upper East Side Pain Medicine, P.C.
    • Syosset, New York, United States, 11791
      • Comprehensive Pain Management
    • Williamsville, New York, United States, 14221
      • APWI
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America
  • Pennsylvania
    • New Castle, Pennsylvania, United States, 16101
      • J. Fred Stoner, MD
    • Wind Gap, Pennsylvania, United States, 18091
      • Progressive Pain Solutions
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Jerrold Rosenberg, MD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic Comprehensive Breast Center
  • Texas
    • Dallas, Texas, United States, 75235
      • PRIDE
  • Washington
    • Kennewick, Washington, United States, 99336
      • Columbia Basin Hematology & Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapidity of BTcP	Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.	one month

Collaborators and Investigators

• Sponsor: Galena Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; diary; Breakthrough cancer pain; Abstral; BTcP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: RELIEF