Neoplasm Clinical Trial
— CHIMIO ORALEOfficial title:
Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
Therapeutic education is an effective way to support the prescription of oral chemotherapy in
oncology. It aims to increase adherence to treatment, to better control the side effects and
reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes
region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth)
decided to collaborate on a project to implement an adapted Therapeutic Education Program
context of each of these institutions.
The objective of this study is to evaluate the implementation of the intervention in the 3
participating centers, over 1 year:
1. Assess the achievement of the target population
2. Evaluate the adaptation of intervention in context
3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life,
identification of interactions with the environment linked to the center, identification
of unintended effects of the intervention.
4. Assessing the sustainability of the intervention
Status | Recruiting |
Enrollment | 600 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard: - Age over 18 years - Introducing an active cancer (local extension, locoregional or metastatic) - Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress Exclusion Criteria: - Refusal to participate, protected adult patient under guardianship. - Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions. - Patient with documented history of cognitive or psychiatric disorders. - Patient on adjuvant therapy or hormone therapy for prostate cancer |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | |
France | CH Lyon Sud | Pierre Bénite | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez |
Lead Sponsor | Collaborator |
---|---|
Institut de Cancérologie de la Loire | Centre Leon Berard, Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of affected population | 3 months | ||
Primary | Level of acquisition of knowledge | Questionnaire composed of numerous questions dealing with patient's knowledge about his/her disease, treatment and treatment's side effects . Answers are quoted in Yes/No and a global scoring is made with all answers. Final measure is a percentage of good answers. | 3 months | |
Primary | Anxiety and Depression | measured with the Hospital Anxiety Depression Scale (Zigmond & Snaith, 1983 ), wich gives separated results about the level of anxiety and of depression according to the level of scoring to a set of 14 questions. Questions are rated from 0-3, and the anxiety and depression subscale scores range from 0-21. The cutoff for each subscale is eight. | 3 months | |
Primary | Quality of Life Questionnaire | 3 months | ||
Primary | Morisky Measurement Adherence Scale | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT00199836 -
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
|
Phase 1 | |
Completed |
NCT01672944 -
Evaluating Biobanking Educational Tools
|
N/A | |
Not yet recruiting |
NCT02226289 -
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
|
Phase 2 | |
Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
Completed |
NCT02747342 -
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer
|
Phase 1 | |
Completed |
NCT02536586 -
A Study of LY3023414 in Japanese Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02309164 -
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
|
N/A | |
Completed |
NCT02394821 -
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
|
Phase 3 | |
Completed |
NCT01457196 -
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
|
N/A | |
Completed |
NCT00143533 -
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05450562 -
Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00001835 -
Oxaliplatin in Cancer Patients With Impaired Kidney Function
|
Phase 1 | |
Completed |
NCT00001341 -
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease
|
Phase 1 | |
Completed |
NCT01425008 -
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
|
Phase 1 | |
Recruiting |
NCT05101798 -
The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial
|
Phase 2 | |
Completed |
NCT01920061 -
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
|
Phase 1 | |
Terminated |
NCT03251924 -
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02851706 -
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
|