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Completed

NCT Number: NCT01936636

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

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.

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Key information

Conditions

Quality of Life Breakthrough Cancer Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physicians Pain Specialists of Alabama, P.C., Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Galena Biopharma, Inc.

Industry

Registry information

Official study 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

Acronym: RELIEF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2013
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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