Metastatic Solid TumorADHESIPHNCT03263416
Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.
A study testing Dedicated and coordinated follow-up and Standard follow-up in people with Metastatic Solid Tumor, run by Institut Claudius Regaud at 4 sites in France.
Trial summary
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- Dedicated and coordinated follow-up and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Jul 2017to 25 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line
- Age > or = 18 years old
- Affiliated to the french social security system
- Patient must provide written informed consent prior to any study-specific procedure or assessment
Who cannot join
- Patient not available by phone or with no caregiver who can answer the phone for him
- Pregnant or breastfeeding women
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient protected by law
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique Claude Bernard
Albi, 81000
Centre Hospitalier Intercommunal Castres Mazamet
Castres, 81108
Clinique Des Cedres
Cornebarrieu
Institut Claudius Regaud
Toulouse, 31059
About this study
Official title: Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation.
Patients will be randomized into one of two study arms:
Read more
Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist.
Arm B: Standard follow-up during the treatment period.
Patients will be followed during 6 months.
- Conditions
- Metastatic Solid Tumor
- Being tested
- Dedicated and coordinated follow-up, Standard follow-up
- Keywords
- Metastatic solid tumor, Oral Targeted Therapy, Treatment adherence
- Medical subject headings
- Neoplasm Metastasis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated and coordinated follow-upOther
- Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period
- Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist
- Completion of QLQ-C30 and GIRERD questionnaires
Standard follow-upOther
- Completion of QLQ-C30 and GIRERD questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Other: Dedicated and coordinated follow-up |
| Arm B | Other | Standard Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)
Measured: 6 months per patient
Secondary outcomes (3)
Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation
Measured: 6 months per patient
Quality of life using the QLQ-C30 questionnaire
Measured: 6 months per patient
Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Measured: 6 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start24 Jul 2017
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine CHEVREAU, MD, Principal investigator, Institut Universitaire du Cancer Toulouse Oncopole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263416
- Sponsor's protocol ID
- 17GENE02
- Acronym
- ADHESIPH
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2017
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.
- ClinicalTrials.gov ID
- NCT03263416
- Acronym / sponsor ID
- ADHESIPH / 17GENE02
- Conditions
- Metastatic Solid Tumor
- Keywords
- Metastatic solid tumor, Oral Targeted Therapy, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 28 Aug 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.
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation.
Patients will be randomized into one of two study arms:
Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist.
Arm B: Standard follow-up during the treatment period.
Patients will be followed during 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Dedicated and coordinated follow-up |
| Arm B | Other | Other: Standard follow-upStandard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line
- Age > or = 18 years old
- Affiliated to the french social security system
- Patient must provide written informed consent prior to any study-specific procedure or assessment
Key exclusion criteria (4 listed)
- Patient not available by phone or with no caregiver who can answer the phone for him
- Pregnant or breastfeeding women
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient protected by law
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 |
|---|---|---|
| Dedicated and coordinated follow-up* Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period * Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist * Completion of QLQ-C30 and GIRERD questionnaires | Other | Arm A |
| Standard follow-up- Completion of QLQ-C30 and GIRERD questionnaires | Other | Arm B |
Primary outcome
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
Time frame: 6 months per patient
This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)
3 secondary outcomes
Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation
Time frame: 6 months per patient
Quality of life using the QLQ-C30 questionnaire
Time frame: 6 months per patient
Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time frame: 6 months per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- 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.
Christine CHEVREAU, MD principal investigator
Institut Universitaire du Cancer Toulouse Oncopole
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dedicated and coordinated follow-up and Standard follow-up in people with Metastatic Solid Tumor, run by Institut Claudius Regaud at 4 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration. (time frame: 6 months per patient). 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 31 Jan 2022.