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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.

Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.

The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Treatment of Breakthrough Cancer Pain According to European Guidelines

Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.

Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)

BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)

BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)

Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)

Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).

Number of specialist/GP visits due to cancer pain during the observation period

Number of hospitalizations due to cancer pain during the observation period

Length of hospitalizations (days) due to cancer pain during the observation period

Number of admittances to ER due to cancer pain during the observation period

Aziende Chimiche Riunite Angelini Francesco S.p.A

Breakthrough Pain

Nycomed Clinical Trial Operations

The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.
Treatment of Breakthrough Cancer Pain According to European Guidelines	NCT04468490	Breakthrough Ca...		18 Years -	Aziende Chimiche Riunite Angelini Francesco S.p.A
Treatment of Breakthrough Cancer Pain According to European Guidelines	NCT04468490	Breakthrough Ca...		18 Years -	Aziende Chimiche Riunite Angelini Francesco S.p.A
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.
Instanyl® Non-Interventional Study	NCT01045603	Breakthrough Ca...		18 Years -	Takeda
Instanyl® Non-Interventional Study	NCT01045603	Breakthrough Ca...		18 Years -	Takeda

Spots Global Cancer Trial Database for btcp

Every month we try and update this database with for btcp 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 btcp

Every month we try and update this database with for btcp 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 btcp 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.