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Observational Study to Assess Adherence Oral Anticancer Therapies (ObservAG)

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ClinicalTrials.gov Identifier: NCT03195972
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.

However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.

This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.

The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.


Condition or disease Intervention/treatment
Adherence, Patient Other: Drug diary filling

Detailed Description:

Primary objective

- To evaluate adherence to oral anti-cancer therapies at 3 months

Secondary objectives

  • To evaluate the adherence to 3 months according to the age of the patients (less than 75 years versus 75 years and more)
  • Evaluate compliance at 1 and 2 months
  • Evaluate toxicity at 1, 2 and 3 months according to compliance according to criteria CTCAE 4.03.
  • Evaluate response to treatment at 3 months based on adherence
  • Evaluate the factors associated with adherence and describe the reasons for non-adherence.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Observational Study to Assess Adherence of Oral Anticancer Therapies
Actual Study Start Date : December 23, 2016
Actual Primary Completion Date : December 23, 2016
Actual Study Completion Date : September 4, 2018

Intervention Details:
  • Other: Drug diary filling
    patient will fill every day a drug diary


Primary Outcome Measures :
  1. Compliance with treatment [ Time Frame: 3 months ]
    Treatment adherence will be assessed by the number of treatment units taken in relation to the prescribed amount. A patient will be considered as observing if he has received at least 80% of the dose initially prescribed.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 3 months ]
    The toxicity of the treatment will be assessed and graded, at each medical consultation, according to the classification NCI-CTCAE V4.03, in observing and non-observing patients.

  2. Response to treatment [ Time Frame: 3 months ]
    Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.
Criteria

Inclusion Criteria:

  • Age> 18 years
  • Cancer proved histologically.
  • Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy
  • Illness measurable or assessable by imaging
  • Patient affiliated to a social security scheme
  • Patient having been informed of the study
  • Non-opposition of the patient

Exclusion Criteria:

  • Contraindication to oral treatment
  • Patient's refusal
  • Patient under tutelage, curatorship or safeguard of justice
  • Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study

Information from the National Library of Medicine

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): NCT03195972


Locations
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France
CGFL
Dijon, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc

Additional Information:

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03195972     History of Changes
Other Study ID Numbers: ObservAG
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Georges Francois Leclerc:
Adherence, Patient, oncology, oral therapy