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

Sponsor

Galena Biopharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01936636

Collaborator

(none)

164

Enrollment

Locations

Duration (Months)

4.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

164 participants

Time Perspective:

Prospective

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 :

Oct 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Quality of Life [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

Rapidity of BTcP [one month]
Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physicians Pain Specialists of Alabama, P.C.	Mobile	Alabama	United States	36606
2	Pain Centers Nationwide	Peoria	Arizona	United States	83582
3	Valley Pain Consultants	Scottsdale	Arizona	United States	85254
4	Coastal Pain Research	Carlsbad	California	United States	92009
5	Navajo Road Pain Management Center	El Cajon	California	United States	92020
6	California Cancer Associates for Research and Excellence, Inc.	Fresno	California	United States	93720
7	Interventional Pain Management	Irvine	California	United States	92618
8	Alexander Ford, MD	Los Angeles	California	United States	90035
9	Cancer Care Institute	Los Angeles	California	United States	90036
10	Pete J. Ruane, MD, Inc.	Los Angeles	California	United States	90036
11	Pain Institute of Santa Monica	Santa Monica	California	United States	90404
12	Randy Scharlach, MD	Woodland Hills	California	United States	91367
13	Red Rocks Center for Rehabilitation	Golden	Colorado	United States	80401
14	Western Connecticut Health Network, Danbury Hospital	Danbury	Connecticut	United States	06810
15	Pain Management Associates of CT, PC	Stamford	Connecticut	United States	06905
16	Florida Cancer Care	Plantation	Florida	United States	33324
17	Interventional Spine and Pain Management	Atlanta	Georgia	United States	30309
18	Cancer Treatment Centers of America	Newnan	Georgia	United States	30265
19	Pain Management Institute	Overland Park	Kansas	United States	66210
20	Physiatry Consultants	Bay City	Michigan	United States	48796
21	Michigan Interventional Pain Center	Brownstown	Michigan	United States	48183
22	Glenn Saperstein, D.O., LLC	Saginaw	Michigan	United States	48604
23	Advanced Physical Medicine	St. Clair Shores	Michigan	United States	48080
24	Michigan Spine & Pain	West Bloomfield	Michigan	United States	48322
25	Fountain Medical Group	New York	New York	United States	10021
26	Upper East Side Pain Medicine, P.C.	New York	New York	United States	36607
27	Comprehensive Pain Management	Syosset	New York	United States	11791
28	APWI	Williamsville	New York	United States	14221
29	Akron General Medical Center	Akron	Ohio	United States	44302
30	Cancer Treatment Centers of America	Tulsa	Oklahoma	United States	74133
31	J. Fred Stoner, MD	New Castle	Pennsylvania	United States	16101
32	Progressive Pain Solutions	Wind Gap	Pennsylvania	United States	18091
33	Jerrold Rosenberg, MD	Providence	Rhode Island	United States	02904
34	The West Clinic Comprehensive Breast Center	Germantown	Tennessee	United States	38138
35	PRIDE	Dallas	Texas	United States	75235
36	Columbia Basin Hematology & Oncology	Kennewick	Washington	United States	99336