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

November 3, 2015 updated by: Galena Biopharma, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: One month

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rapidity of BTcP
Time Frame: one month
Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galena Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RELIEF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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