Solid or Lymphoid Malignant DiseaseANNONCEPNCT02328560
Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
An observational study of Solid or Lymphoid Malignant Disease, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid or Lymphoid Malignant Disease
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Oct 2016
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing treatment with first-line IV chemotherapy
Who may be able to join
- 18 ≤ age <75 years;
- WHO ≤ 1;
- Patients with cancer and candidate for chemotherapy treatment of first intention;
- Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;
- Patient affiliated to a social security scheme;
- Mastery of the French language;
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- Informed Consent and signed;
- In the first cohort, patients will have received paramedical consultation announcement in the days preceding the first cycle of chemotherapy;
- In the second cohort, patients have not received paramedical consultation announcement.
Who cannot join
- Patient deprived of liberty, under guardianship;
- Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;
- Exclusive Oral Chemotherapy;
- Exclusive Targeted therapy;
- Targeted therapy to be introduced during chemotherapy;
- Presence of cerebral localization;
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- Pain requiring analgesics bearing 3;
- Patient in medical and social structure;
- Inability to submit to medical monitoring test for geographical, social or psychological reasons;
- Rare Cancers making matching difficult (sarcomas of soft tissue and internal organs, malignant neuroendocrine tumors sporadic and hereditary rare ...)
Trial locations and contacts
1 site in 1 country.
About this study
The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a better understanding of the disease and treatment incurred, which should lead to the implementation of joint strategies between the healthcare team and the patient to prevent the effects of and treatment of the disease by the patient and caregivers.
This improvement is to promote the fair treatment by reducing patient anxiety and / or carers and involving them in the management of their disease. In this context, it is shown a profit of paramedical consultation for the patient, it will work, based on the recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.
Read more
This work should also help measure the impact of ad paramedical consultation on optimizing care consumption off-line therapy and to assess the associated costs.
For patients who received paramedic ad or not consultation, it will therefore be of particular compare intercurrent hospitalizations, commuting structure of care, the number of consultations with the doctor, the reports of cure, additional biological monitoring or other health care consumption.
With the participation of several centers in the fight against cancer, this study will provide valuable information on the practice of paramedical consultation ad in several tumor sites.
It will objectify the benefit provided by the Medical device announcement for both patients and the organization and use of care prerequisite to encourage better integration of this device in the course of patient care, the consultation paramedical ad remaining poorly understood by many health professionals.
- Conditions
- Solid or Lymphoid Malignant Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paramedical ad consultation | Monitoring will be the same in the 2 groups; That paramedical consultation announcement is made in current practice. | |
| No paramedical ad consultation | Monitoring will be the same in the 2 groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care consumption
Compare among patients candidates for chemotherapy treatment IV first line, the proportions of patients who need more care than anticipated during the first cycle of chemotherapy among patients who have had paramedical announcement of consultation and those who have not had.
Measured: Up to 18 weeks
Secondary outcomes (4)
Hospital costs
Evaluate and compare between the 2 groups the total hospital costs
Measured: Up to 18 weeks
Number of patients with adverse events
Evaluate and compare between the 2 groups the health care consumption and side effects of chemotherapy
Measured: Up to 18 weeks
Satisfaction measured by self-administered questionnaires
Evaluate and compare between the 2 groups patient and physicians satisfaction
Measured: Up to 18 weeks
Anxiety and depression measured by HADS scale
Compare baseline characteristics of the 2 groups (anxiety and depression)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionOct 2016
Why it stopped: Loss of recrutement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid or Lymphoid Malignant DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François GERNIER, health executive, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328560
- Sponsor's protocol ID
- ANNONCEP
- Acronym
- ANNONCEP
- Status last verified
- Feb 2016
- First submitted
- 10 Dec 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT02328560
- Acronym / sponsor ID
- ANNONCEP / ANNONCEP
- Conditions
- Solid or Lymphoid Malignant Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of recrutement
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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.
The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a better understanding of the disease and treatment incurred, which should lead to the implementation of joint strategies between the healthcare team and the patient to prevent the effects of and treatment of the disease by the patient and caregivers.
This improvement is to promote the fair treatment by reducing patient anxiety and / or carers and involving them in the management of their disease. In this context, it is shown a profit of paramedical consultation for the patient, it will work, based on the recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.
This work should also help measure the impact of ad paramedical consultation on optimizing care consumption off-line therapy and to assess the associated costs.
For patients who received paramedic ad or not consultation, it will therefore be of particular compare intercurrent hospitalizations, commuting structure of care, the number of consultations with the doctor, the reports of cure, additional biological monitoring or other health care consumption.
With the participation of several centers in the fight against cancer, this study will provide valuable information on the practice of paramedical consultation ad in several tumor sites.
It will objectify the benefit provided by the Medical device announcement for both patients and the organization and use of care prerequisite to encourage better integration of this device in the course of patient care, the consultation paramedical ad remaining poorly understood by many health professionals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paramedical ad consultation | – | –Monitoring will be the same in the 2 groups; That paramedical consultation announcement is made in current practice. |
| No paramedical ad consultation | – | –Monitoring will be the same in the 2 groups |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment with first-line IV chemotherapy
Key inclusion criteria (9 listed)
- 18 ≤ age <75 years;
- WHO ≤ 1;
- Patients with cancer and candidate for chemotherapy treatment of first intention;
- Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;
- Patient affiliated to a social security scheme;
Key exclusion criteria (10 listed)
- Patient deprived of liberty, under guardianship;
- Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;
- Exclusive Oral Chemotherapy;
- Exclusive Targeted therapy;
- Targeted therapy to be introduced during chemotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Care consumption
Time frame: Up to 18 weeks
Compare among patients candidates for chemotherapy treatment IV first line, the proportions of patients who need more care than anticipated during the first cycle of chemotherapy among patients who have had paramedical announcement of consultation and those who have not had.
4 secondary outcomes
Hospital costs
Time frame: Up to 18 weeks
Number of patients with adverse events
Time frame: Up to 18 weeks
Satisfaction measured by self-administered questionnaires
Time frame: Up to 18 weeks
Anxiety and depression measured by HADS scale
Time frame: Inclusion
Results and safety
The study was stopped early (reason given: Loss of recrutement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
François GERNIER, health executive principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid or Lymphoid Malignant Disease, run by Centre Francois Baclesse at 1 site 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Loss of recrutement). Results are not available in the source record.
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?
Care consumption (time frame: Up to 18 weeks). 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 Oct 2016.