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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01601-42 | Other Identifier | ANSM ID RCB |
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The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.
This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.
In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.
The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Standard Care | Other | standard care |
|
| B-manipulator consultation radiotherapy added to standard care | Experimental | manipulator consultation radiotherapy added to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | standard care |
| |
| manipulator consultation radiotherapy added to standard care |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-INFO25 | Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen BENEZERY, md | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine LACASSAGNE | Nice | 0 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-Standard Care | standard care |
| FG001 | B-manipulator Consultation Radiotherapy Added to Standard Care | manipulator consultation radiotherapy added to standard care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-Standard Care | standard care |
| BG001 | B-manipulator Consultation Radiotherapy Added to Standard Care | manipulator consultation radiotherapy added to standard care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EORTC QLQ-INFO25 | Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-Standard Care | standard care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Centre Antoine Lacassagne | +33 4 92 03 10 00 | DRCI-Promotion@nice.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2016 | Jun 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
manipulator consultation radiotherapy added to standard care |
|
|
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | B-manipulator Consultation Radiotherapy Added to Standard Care | manipulator consultation radiotherapy added to standard care | 0 | 150 | 0 | 150 | 0 | 150 |
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