Observational Registry Study of Quality of Life When Treating BTcP With Abstral (RELIEF)
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| ClinicalTrials.gov Identifier: NCT01936636 |
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Recruitment Status :
Completed
First Posted : September 6, 2013
Last Update Posted : November 5, 2015
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| Condition or disease | Intervention/treatment |
|---|---|
| Quality of Life Breakthrough Cancer Pain | Drug: Fentanyl |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 164 participants |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 4 Weeks |
| 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 : | October 2013 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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 |
- 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
- Rapidity of BTcP [ Time Frame: one month ]Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936636
Show 36 study locations
| Responsible Party: | Galena Biopharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT01936636 |
| Other Study ID Numbers: |
RELIEF |
| First Posted: | September 6, 2013 Key Record Dates |
| Last Update Posted: | November 5, 2015 |
| Last Verified: | November 2015 |
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Breakthrough cancer pain diary quality of life Abstral BTcP |
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Cancer Pain Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |