Solid or Lymphoid Malignant Disease Clinical Trial
— ANNONCEPOfficial title:
Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
| NCT number | NCT02328560 |
| Other study ID # | ANNONCEP |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | December 10, 2014 |
| Last updated | October 28, 2016 |
| Start date | January 2016 |
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.
| Status | Terminated |
| Enrollment | 44 |
| Est. completion date | |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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; - 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. Exclusion Criteria: - 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; - 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 ...) - Inclusion in another clinical trial. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Centre François BACLESSE | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 18 weeks | No |
| Secondary | Hospital costs | Evaluate and compare between the 2 groups the total hospital costs | Up to 18 weeks | No |
| Secondary | Number of patients with adverse events | Evaluate and compare between the 2 groups the health care consumption and side effects of chemotherapy | Up to 18 weeks | No |
| Secondary | Satisfaction measured by self-administered questionnaires | Evaluate and compare between the 2 groups patient and physicians satisfaction | Up to 18 weeks | No |
| Secondary | Anxiety and depression measured by HADS scale | Compare baseline characteristics of the 2 groups (anxiety and depression) | Inclusion | No |