CancerADOPT-PRESTAGENCT03296150
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
A study testing PRESTAGE in people with Cancer and Oral Anticancer Drugs, run by Hospices Civils de Lyon at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Oral Anticancer Drugs
- What is being tested?
- PRESTAGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 9 sitesFrance
- Study dates
- 29 Mar 2018to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 6 recruiting
- Recruiting
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
Bron, 69500
François DUCRAY, MD, francois.ducray@chu-lyon.fr
François DUCRAY, MD
- Withdrawn
Service de Gériatrie, Centre Hospitalier de Givors
Givors, 69700
- Withdrawn
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
La Tronche, 38700
- Recruiting
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
Lyon, 69003
Byeul-A KIM, MD, byeul-a.kim@chu-lyon.fr
Elisabeth CASTEL-KREMER, MD
- Recruiting
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
Lyon, 69004
Amandine BRUYAS, MD, amandine.bruyas@chu-lyon.fr
- Not yet recruiting
Service d'oncologie médicale, Cnetre Léon Bérard
Lyon, 69373 cedex 08
Olivier TREDAN, MD, olivier.tredan@lyon.unicancer.fr
Olivier TREDAN, MD
- Not yet recruiting
Service d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, 74370
Laëtitia STEFANI, MD, lstefani@ch-annecygenevois.fr
Laëtitia STEFANI, MD
- Recruiting
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, 69310
Olivia LE SAUX, olivia.lesaux@gmail.com
Claire FALANDRY, MD, claire.falandry@chu-lyon.fr
- Withdrawn
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Etienne, 42100
About this study
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
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
- Cancer, Oral Anticancer Drugs
- Being tested
- PRESTAGE
- Keywords
- therapeutic educational program, adherence, quality of life, elderly, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESTAGEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm : Information | No intervention | Patients will receive the usual standard information delivered to patients |
| Intervention arm : Therapeutic educational program | Experimental | Patients will receive the therapeutic educational program "PRESTAGE" Receives: Behavioral: PRESTAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 4 months (after intervention or information)
Secondary outcomes (6)
Adherence evaluated by Morisky questionnaires
Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.
Measured: 4 months to 12 months
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.
Measured: 4 months to 12 months
Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire
Measured: 4 months to 12 months
Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire
Measured: 4 months to 12 months
Health-related quality of life evaluated by the EORTC quality of life questionnaire
Measured: 4 months to 12 months
Changes in patients' behaviors evaluated by questionnaires
Beliefs about Medication questionnaire and satisfaction with medication questionnaires
Measured: 4 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start29 Mar 2018
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia LE SAUX, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296150
- Sponsor's protocol ID
- 69HCL16_0149
- Acronym
- ADOPT-PRESTAGE
- Status last verified
- May 2024
- First submitted
- 23 Sep 2017
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03296150
- Acronym / sponsor ID
- ADOPT-PRESTAGE / 69HCL16_0149
- Conditions
- Cancer, Oral Anticancer Drugs
- Keywords
- therapeutic educational program, adherence, quality of life, elderly, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm : Information | No intervention | –Patients will receive the usual standard information delivered to patients |
| Intervention arm : Therapeutic educational program | Experimental | Behavioral: PRESTAGEPatients will receive the therapeutic educational program "PRESTAGE" |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESTAGEPRESTAGE 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. | Behavioural | Intervention arm : Therapeutic educational program |
Primary outcome
Adherence evaluated by MicroElectronic Monitoring System
Time frame: 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.
6 secondary outcomes
Adherence evaluated by Morisky questionnaires
Time frame: 4 months to 12 months
Adherence evaluated by pharmacy medication refill -based adherence
Time frame: 4 months to 12 months
Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire
Time frame: 4 months to 12 months
Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire
Time frame: 4 months to 12 months
Health-related quality of life evaluated by the EORTC quality of life questionnaire
Time frame: 4 months to 12 months
Changes in patients' behaviors evaluated by questionnaires
Time frame: 4 months to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivia LE SAUX study chair
Hospices Civils de Lyon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESTAGE in people with Cancer and Oral Anticancer Drugs, run by Hospices Civils de Lyon at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia LE SAUX (04 78 86 37 75 ext. +33, olivia.lesaux@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence evaluated by MicroElectronic Monitoring System (time frame: at 4 months (after intervention or information)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.