Quality of LifeRELIEFNCT01936636
Observational Registry Study of Quality of Life When Treating BTcP With Abstral
An observational study of Quality of Life and Breakthrough Cancer Pain, run by Galena Biopharma, Inc. at 36 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Breakthrough Cancer Pain
- What is being tested?
- Fentanyl
- How many people
- 164 participants
- Where
- 36 sitesUnited States
- Study dates
- Oct 2013to Jun 2015
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Akron General Medical Center
Akron, Ohio, 44302
Interventional Spine and Pain Management
Atlanta, Georgia, 30309
Physiatry Consultants
Bay City, Michigan, 48796
Michigan Interventional Pain Center
Brownstown, Michigan, 48183
Coastal Pain Research
Carlsbad, California, 92009
PRIDE
Dallas, Texas, 75235
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, 06810
Navajo Road Pain Management Center
El Cajon, California, 92020
California Cancer Associates for Research and Excellence, Inc.
Fresno, California, 93720
The West Clinic Comprehensive Breast Center
Germantown, Tennessee, 38138
Red Rocks Center for Rehabilitation
Golden, Colorado, 80401
Interventional Pain Management
Irvine, California, 92618
Columbia Basin Hematology & Oncology
Kennewick, Washington, 99336
Alexander Ford, MD
Los Angeles, California, 90035
Cancer Care Institute
Los Angeles, California, 90036
Pete J. Ruane, MD, Inc.
Los Angeles, California, 90036
Physicians Pain Specialists of Alabama, P.C.
Mobile, Alabama, 36606
J. Fred Stoner, MD
New Castle, Pennsylvania, 16101
Fountain Medical Group
New York, New York, 10021
Upper East Side Pain Medicine, P.C.
New York, New York, 36607
Cancer Treatment Centers of America
Newnan, Georgia, 30265
Pain Management Institute
Overland Park, Kansas, 66210
Pain Centers Nationwide
Peoria, Arizona, 83582
Florida Cancer Care
Plantation, Florida, 33324
Jerrold Rosenberg, MD
Providence, Rhode Island, 02904
Glenn Saperstein, D.O., LLC
Saginaw, Michigan, 48604
Advanced Physical Medicine
Saint Clair Shores, Michigan, 48080
Pain Institute of Santa Monica
Santa Monica, California, 90404
Valley Pain Consultants
Scottsdale, Arizona, 85254
Pain Management Associates of CT, PC
Stamford, Connecticut, 06905
Comprehensive Pain Management
Syosset, New York, 11791
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133
Michigan Spine & Pain
West Bloomfield, Michigan, 48322
APWI
Williamsville, New York, 14221
Progressive Pain Solutions
Wind Gap, Pennsylvania, 18091
Randy Scharlach, MD
Woodland Hills, California, 91367
About this study
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
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.
Read the 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.
- Conditions
- Quality of Life, Breakthrough Cancer Pain
- Being tested
- Fentanyl
- Keywords
- Breakthrough cancer pain, diary, quality of life, Abstral, BTcP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
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
Measured: One month
Secondary outcomes (1)
Rapidity of BTcP
Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Galena Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936636
- Sponsor's protocol ID
- RELIEF
- Acronym
- RELIEF
- Status last verified
- Nov 2015
- First submitted
- 2 Sep 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01936636
- Acronym / sponsor ID
- RELIEF / RELIEF
- Conditions
- Quality of Life, Breakthrough Cancer Pain
- Keywords
- Breakthrough cancer pain, diary, quality of life, Abstral, BTcP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Galena Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients treated for BTcP | – | Drug: FentanylAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl | Drug | Cancer patients treated for BTcP |
Primary outcome
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
1 secondary outcome
Rapidity of BTcP
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Breakthrough Cancer Pain, run by Galena Biopharma, Inc. at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.