Observational Study to Assess Adherence Oral Anticancer T... | NCT03195972

Studies
Observational Study to Assess Adherence Oral Anticancer Therapies

NCT03195972

Sponsor

Centre Georges Francois Leclerc

Status

Completed

Last Update Posted

Nov 5, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Adherence, Patient

Interventions

Drug diary filling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2016Actual

Primary Completion Date

Dec 23, 2016Actual

Completion Date

Sep 4, 2018Actual

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 20, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2019

Last Update Posted Date

Nov 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug diary filling	Other	patient will fill every day a drug diary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compliance with treatment	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.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Toxicity	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.	3 months
Response to treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CGFL		Dijon		21079	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance
D009369	Neoplasms

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided