Observational Study to Assess Adherence Oral Anticancer Therapies

NCT03195972 | Completed

• 1 other identifier: ObservAG
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Patient

Keywords

Adherence, Patient, oncology, oral therapy

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Toxicity

  3 months

• Response to treatment

  3 months

Interventions

Drug diary filling OTHER

patient will fill every day a drug diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

CGFL

Dijon, 21079, France

Location

MeSH Terms

Conditions

Patient Compliance; Neoplasms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 22, 2017
• Study Start: December 23, 2016
• Primary Completion: December 23, 2016
• Study Completion: September 4, 2018
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)