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

Galena Biopharma

Status: Completed

Conditions: Quality of Life; Breakthrough Cancer Pain

Treatments: Drug: Fentanyl

Study type: Observational

Funder types: Industry

Identifiers

NCT01936636

RELIEF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

164 participants in 1 patient group

Cancer patients treated for BTcP

Description:

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.

Treatment:

Drug: Fentanyl