Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01936636
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Galena Biopharma, Inc.

Brief 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.

Condition or disease Intervention/treatment
Quality of Life Breakthrough Cancer Pain 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 164 participants
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
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
Study Start Date : October 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936636


Locations
Show Show 36 study locations
Sponsors and Collaborators
Galena Biopharma, Inc.
Additional Information:

Layout table for additonal information
Responsible Party: Galena Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT01936636    
Other Study ID Numbers: RELIEF
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Keywords provided by Galena Biopharma, Inc.:
Breakthrough cancer pain
diary
quality of life
Abstral
BTcP
Additional relevant MeSH terms:
Layout table for MeSH terms
Cancer Pain
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics