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

Cancer Clinical Trial

— ADOPT-PRESTAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03296150
• Other study ID #: 69HCL16_0149
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: March 2025

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: Olivia LE SAUX
• Phone: 04 78 86 37 75
• Email: olivia.lesaux[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Oral Anticancer Drugs

Intervention

Behavioral:
• PRESTAGE
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.

Locations

Country	Name	City	State
France	Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL	Bron
France	Service de Gériatrie, Centre Hospitalier de Givors	Givors
France	Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole	La Tronche
France	Service d'oncologie médicale, Cnetre Léon Bérard	Lyon
France	Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL	Lyon
France	Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL	Lyon
France	Service d'oncologie, Centre Hospitalier Annecy Genevois	Metz-Tessy
France	Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)	Pierre-Bénite
France	service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence evaluated by MicroElectronic Monitoring System	Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.	at 4 months (after intervention or information)
Secondary	Adherence evaluated by Morisky questionnaires	Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.	4 months to 12 months
Secondary	Adherence evaluated by pharmacy medication refill -based adherence	Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.	4 months to 12 months
Secondary	Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire		4 months to 12 months
Secondary	Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire		4 months to 12 months
Secondary	Health-related quality of life evaluated by the EORTC quality of life questionnaire		4 months to 12 months
Secondary	Changes in patients' behaviors evaluated by questionnaires	Beliefs about Medication questionnaire and satisfaction with medication questionnaires	4 months to 12 months