RecruitingNot ApplicableNCT03296150

ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE

ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE

Sponsor

Hospices Civils de Lyon

Enrollment

139 participants

Start Date

Mar 29, 2018

Study Type

INTERVENTIONAL

Conditions

Cancer Oral Anticancer Drugs

Summary

As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized. PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being. ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.

Eligibility

Min Age: 70 Years

Inclusion Criteria8

Patients older than 70 years,
For which oral anticancer therapy has been initiated within the previous 45 days or will be started within 45 days
For any type of cancer, solid or hematologic, any stage
Estimated life expectancy> 6 months
Affiliation to social security or equivalent
Patients who can answer questionnaires and protocol evaluations
Informed consent signed by patients
Domiciled within 50 km around the investigating center

Exclusion Criteria5

For patients with breast cancer, exclusive treatment with hormone therapy
First-generation Hormone Therapy in Prostate Cancer
Patient not available for regular follow-up whatever the cause (geographic, family, social, psychological)
Any serious condition, ie serious physical or mental, leading to a disability permanent and likely to prevent the proper course of treatment
Patient deprived of liberty or under guardianship

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Interventions

BEHAVIORALPRESTAGE

PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.