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NCT Number: NCT03195972

Observational Study to Assess Adherence Oral Anticancer Therapies

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.

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Key information

Conditions

Adherence, Patient Behavior Health Behavior Neoplasms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CGFL

Dijon, 21079, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug diary filling

Other

patient will fill every day a drug diary

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

Observational Study to Assess Adherence of Oral Anticancer Therapies

Acronym: ObservAG

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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