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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01251-52 | Other Identifier | ANSM |
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This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:
The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.
Unmet need characterize in 4 points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological and Social Consultation | Experimental | Psychological and Social Consultation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological and Social Consultation | Other | Psychological and Social Consultation at Baseline, during the study and at the end of follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life : EORTC QLQ-C30 Scores | Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001). 15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | At baseline and 5 months |
| Cognitive Complaints : FACT Cog Scale Scores | Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3 Assessed using median total score (range 0-132) and median scores of these 4 dimensions :
| At baseline and 5 months |
| Professional Recovery Scale Scores | Professional recovery was evaluated by using the Scale of motivation to Professional recovery. This scale was constructed for the needs of this exploratory research and has for vocation a later validation. It includes 62 questions and was assessed using median scores of these 7 dimensions :
| At baseline and 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tiredness : Piper MFI-20 Scale Scores | Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Véronique GERAT-MULLER, PhD | Institut Bergonié - Supportive Oncology Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychological and Social Consultation | Psychological and Social Consultation at Baseline, during the study and at the end of follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychological and Social Consultation | Psychological and Social Consultation at Baseline, during the study and at the end of follow-up |
| 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 | Quality of Life : EORTC QLQ-C30 Scores | Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001). 15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. |
| Posted | Mean | 95% Confidence Interval | scores on a scale | At baseline and 5 months |
|
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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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 | Psychological and Social Consultation | Psychological and Social Consultation at Baseline, during the study and at the end of follow-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Véronique GERAT-MULLER | Institut Bergonié | 0556337839 | v.gerat-muller@bordeaux.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 | May 4, 2017 | Mar 31, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Prospective study
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| At baseline and 5 months |
| Anxio-depressive Troubles : HAD Scale Scores | Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions :
| At baseline and 5 months |
| 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 |
|
| Region of Enrollment | Number | participants |
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| Marital Status | Count of Participants | Participants |
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| SOCIO-PROFESSIONAL CATEGORY | Count of Participants | Participants |
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| PROFESSIONAL STATUS | Count of Participants | Participants |
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| Psychological and Social Consultation |
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up |
|
|
| Primary | Cognitive Complaints : FACT Cog Scale Scores | Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3 Assessed using median total score (range 0-132) and median scores of these 4 dimensions :
|
| Posted | Median | Full Range | scores on a scale | At baseline and 5 months |
|
|
|
| Primary | Professional Recovery Scale Scores | Professional recovery was evaluated by using the Scale of motivation to Professional recovery. This scale was constructed for the needs of this exploratory research and has for vocation a later validation. It includes 62 questions and was assessed using median scores of these 7 dimensions :
|
| Posted | Median | Full Range | scores on a scale | At baseline and 5 months |
|
|
|
| Secondary | Tiredness : Piper MFI-20 Scale Scores | Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :
|
| Posted | Median | Full Range | scores on a scale | At baseline and 5 months |
|
|
|
| Secondary | Anxio-depressive Troubles : HAD Scale Scores | Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions :
|
| Posted | Median | Full Range | scores on a scale | At baseline and 5 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Impact on quality of life - Baseline |
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| Impact on quality of life - 5 months |
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| Comments from others - Baseline |
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| Comments from others - 5 months |
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| Perceived Cognitive Skills - Baseline |
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| Perceived Cognitive Skills - 5 months |
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| Total score - Baseline |
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| Total score - 5 months |
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| Positioning in relation to the job-post-mission - Baseline |
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| Positioning in relation to the job-post-mission - 5 months |
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| Emotion and work - Baseline |
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| Emotion and work - 5 months |
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| Labour relations - Baseline |
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| Labour relations - 5 months |
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| Work and physical/intellectual conditions - Baseline |
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| Work and physical/intellectual conditions - 5 months |
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| Privacy and work - Baseline |
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| Privacy and work - 5 months |
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| Return to work - Baseline |
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| Return to work - 5 months |
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| Behavioural dimension - Baseline |
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| Emotional dimension - 5 months |
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| Sensory dimension - Baseline |
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| Sensory dimension - 5 months |
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| Cognitive-mood dimension - Baseline |
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| Cognitive-mood dimension - 5 months |
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| Total Score Fatigue Scale - Baseline |
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| Total Score Fatigue Scale - 5 months |
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| Depression score - Baseline |
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| Depression score - 5 months |
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