Cancer, Oral Anticancer Drugs
Conditions
Keywords
therapeutic educational program, adherence, quality of life, elderly, cancer
Brief 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.
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence evaluated by MicroElectronic Monitoring System | at 4 months (after intervention or information) | Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence evaluated by Morisky questionnaires | 4 months to 12 months | Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months. |
| Adherence evaluated by pharmacy medication refill -based adherence | 4 months to 12 months | Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months. |
| Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire | 4 months to 12 months | — |
| Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire | 4 months to 12 months | — |
| Health-related quality of life evaluated by the EORTC quality of life questionnaire | 4 months to 12 months | — |
| Changes in patients' behaviors evaluated by questionnaires | 4 months to 12 months | Beliefs about Medication questionnaire and satisfaction with medication questionnaires |
Countries
France
Contacts
Primary ContactOlivia LE SAUX
Backup ContactClaire FALANDRY, MD
Outcome results
None listed