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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.

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.

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.

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

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

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

Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.

Galena Biopharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.

Spots Global Cancer Trial Database for abstral

Every month we try and update this database with for abstral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abstral

Every month we try and update this database with for abstral cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abstral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.