Adherence to Opioids in Oncology Out Patients

Adherence to Opioids in Oncology Out Patients



Sponsors


Source

Hospices Civils de Lyon

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Cancer pain is undertreated despite a good access to opioids in France. Although many factors
are involved, the barriers related to the patient (and his family) are often reported .the
reluctance of the patient or the family to take the prescribed medication is linked to
misconceptions about the opioids , cultural barriers; or the lack of explanations provided by
the physician. Some patients can have undiagnosed slight cognitive impairment .The situation
is now more complicated as appear on the market the new form of opioids for the cancer
breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of
the study is to measure the adherence to opioids in cancer out patients and the associated
factors.

Overall Status

Not yet recruiting

Start Date

2017-09-01

Completion Date

2018-09-01

Primary Completion Date

2018-09-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Rate of cancer out patients with a low adherence to the opioids treatment
One day

Number Of Groups

1

Enrollment

300

Condition


Eligibility

Study Pop

cancer out patients with opioids treatment

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- Cancer out patients with opioids by mouth prescription

- Prescription than more than 8 days

Exclusion Criteria:

- Patient not at home, but in nursing home or other setting were the treatment are given
by medical staff

- Patient unable to answer at the questionnaire

- Opoids given Intravenous or other way than mouth.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Marilène FILBET

Phone

478861482

Phone Ext

+33

Email



Location

Facility

Status

Contact

Centre de Soins Palliatifs Lyon-Sud
Pierre-Bénite 69495 France
Not yet recruiting
Last Name: Marilène FILBET, Pr
Phone: 478861482
Phone Ext: +33
Email: [email protected]

Location Countries

Country

France


Verification Date

2017-08-01

Lastchanged Date

2017-08-09

Firstreceived Date

2017-08-09

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Cross-Sectional



ClinicalTrials.gov processed this data on August 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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