Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oral Anticancer Drugs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRESTAGE | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm : Information
- description
- Patients will receive the usual standard information delivered to patients
- type
- EXPERIMENTAL
- label
- Intervention arm : Therapeutic educational program
- description
- Patients will receive the therapeutic educational program "PRESTAGE"
- interventionNames
- Behavioral: PRESTAGE
Primary outcomes (1)
- measure
- Adherence evaluated by MicroElectronic Monitoring System
- timeFrame
- at 4 months (after intervention or information)
- description
- Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available