Cancer
Conditions
Keywords
Oncology, Work Keeping, Social difficulties, Cognitive Disorders
Brief summary
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: * A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist) * Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops * An information booklet Prepare the work return 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. 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.
Detailed description
Unmet need characterize in 4 points: * Cancer and survival: challenges for cancer patients who want to work while being treated * Cancer and career: Job instability for cancer patients * Difficulties and isolation of patients due to a lack of coordination between healthcare professionals and colleagues/management * Post-treatment cognitive troubles stress and hindered patient return to employment: chemo brain This research-action will propose and evaluate a concrete device: To maintain a professional activity with the support of CAP'Onco during treatment, to balance between quality of life, managing the cancer event and the psychosocial consequences for professional experience, to provide an early, durable and multimodal support to improve work keeping and anticipate return to employment
Interventions
OTHERPsychological and Social Consultation
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective study
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients attending the Institut Bergonié * Informed Consent signed. * Patients affiliated to a French social * living in Gironde * Professional activity at the time of diagnosis * Treated for - breast cancer, Hodgkin's or non-Hodgkin's lymphoma (non-cerebral), testicular cancer * CURATIVE support * At any time during treatment (chemotherapy or radiotherapy, or immunotherapy)
Exclusion criteria
* Patient deprived of liberty or subject to a legal protection measure * History of cancers * Cerebral pathology and / or brain metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life : EORTC QLQ-C30 Scores | At baseline and 5 months | 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. |
| Cognitive Complaints : FACT Cog Scale Scores | At baseline and 5 months | 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 : * Perceived Cognitive Impairment (range 0-72) * Impact on quality of life (range 0-16) * Comments from others (range 0-16) * Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning. |
| Professional Recovery Scale Scores | At baseline and 5 months | 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 : * Work and administrative process (0-100) * Positioning in relation to the job-post-mission (0-100) * Emotion and work (0-100) * Labour relations (0-100) * Work and physical/intellectual conditions (0-100) * Privacy and work (0-100) * Return to work (0-20) Higher scores represent better outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tiredness : Piper MFI-20 Scale Scores | At baseline and 5 months | 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 : * Behavioural * Emotional * Sensory * Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue |
| Anxio-depressive Troubles : HAD Scale Scores | At baseline and 5 months | Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions : * Anxiety * Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychological and Social Consultation Psychological and Social Consultation at Baseline, during the study and at the end of follow-up | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Psychological and Social Consultation | — |
|---|---|---|
| Age, Continuous | 44.9 years | — |
| Marital Status As a couple | 7 Participants | — |
| Marital Status Married | 11 Participants | — |
| Marital Status Single | 10 Participants | — |
| Marital Status Widower | 1 Participants | — |
| PROFESSIONAL STATUS Other | 1 Participants | — |
| PROFESSIONAL STATUS Private Sector | 12 Participants | — |
| PROFESSIONAL STATUS Public Sector | 13 Participants | — |
| PROFESSIONAL STATUS Self-employed worker | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 29 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
| SOCIO-PROFESSIONAL CATEGORY craftsman, shopkeeper, business owner | 3 Participants | — |
| SOCIO-PROFESSIONAL CATEGORY employee | 14 Participants | — |
| SOCIO-PROFESSIONAL CATEGORY executive, intellectual profession | 6 Participants | — |
| SOCIO-PROFESSIONAL CATEGORY intermediate profession | 5 Participants | — |
| SOCIO-PROFESSIONAL CATEGORY person without professional activity | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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 : * Perceived Cognitive Impairment (range 0-72) * Impact on quality of life (range 0-16) * Comments from others (range 0-16) * Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.
Time frame: At baseline and 5 months
Population: * At baseline, 2 patients did not complete the Cognitive complaints questionnaire~* At 5 months, 1 patient did not complete the Cognitive complaints questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Perceived Cognitive Impairment - 5 months | 50.5 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Impact on quality of life - Baseline | 8 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Perceived Cognitive Impairment - Baseline | 39 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Impact on quality of life - 5 months | 14.0 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Comments from others - Baseline | 15 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Comments from others - 5 months | 16 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Perceived Cognitive Skills - Baseline | 13 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Perceived Cognitive Skills - 5 months | 17.5 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Total score - Baseline | 75 scores on a scale |
| Psychological and Social Consultation | Cognitive Complaints : FACT Cog Scale Scores | Total score - 5 months | 96 scores on a scale |
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 : * Work and administrative process (0-100) * Positioning in relation to the job-post-mission (0-100) * Emotion and work (0-100) * Labour relations (0-100) * Work and physical/intellectual conditions (0-100) * Privacy and work (0-100) * Return to work (0-20) Higher scores represent better outcomes
Time frame: At baseline and 5 months
Population: * At baseline, 1 patient did not complete the Professional recovery questionnaire~* At 5 months :~ * 3 patients have missing data for the scores 'Work and administrative process', 'Work and physical/intellectual conditions' and 'Privacy and work'~ * 4 patients have missing data for the scores 'Positioning in relation to the job-post-mission', 'Emotion and work' and 'Labour relations'~ * 1 patient has missing data for the score 'Return to work'
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Psychological and Social Consultation | Professional Recovery Scale Scores | Work and administrative process - Baseline | 58 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Work and administrative process - 5 months | 61 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Emotion and work - 5 months | 60 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Labour relations - Baseline | 55 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Privacy and work - 5 months | 60.5 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Positioning in relation to the job-post-mission - Baseline | 40.5 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Positioning in relation to the job-post-mission - 5 months | 50 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Emotion and work - Baseline | 58.5 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Labour relations - 5 months | 59 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Work and physical/intellectual conditions - Baseline | 42 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Work and physical/intellectual conditions - 5 months | 52.5 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Privacy and work - Baseline | 50.5 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Return to work - Baseline | 10 scores on a scale |
| Psychological and Social Consultation | Professional Recovery Scale Scores | Return to work - 5 months | 14 scores on a scale |
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.
Time frame: At baseline and 5 months
Population: * At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'.~* At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients :~ * 1 patient has missing data for the scores 'Constipation' and 'Diarrhoea'~ * 1 another patient has missing data for the score 'Fatigue'
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Physical functioning - Baseline | 82.9 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Global health status/ quality of life - Baseline | 61.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Global health status/ quality of life - 5 months | 70.8 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Physical functioning - 5 months | 83.2 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Role functioning - Baseline | 72.6 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Role functioning - 5 months | 78.6 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Emotional functioning - Baseline | 61.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Emotional functioning - 5 months | 67.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Cognitive functioning - Baseline | 61.3 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Social functioning - Baseline | 73.2 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Social functioning - 5 months | 82.1 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Fatigue - Baseline | 47.6 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Nausea/ vomiting - 5 months | 3.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Pain - Baseline | 38.7 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Pain - 5 months | 33.3 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Dyspnoea - Baseline | 24.7 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Dyspnoea - 5 months | 16.7 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Diarrhoea - Baseline | 8.3 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Diarrhoea - 5 months | 3.7 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Cognitive functioning - 5 months | 73.2 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Fatigue - 5 months | 43.6 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Nausea/ vomiting - Baseline | 3.6 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Insomnia - Baseline | 52.4 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Insomnia - 5 months | 41.7 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Appetite loss - Baseline | 9.5 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Appetite loss - 5 months | 6.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Constipation - Baseline | 21.4 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Constipation - 5 months | 16.0 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Financial difficulties - Baseline | 21.4 scores on a scale |
| Psychological and Social Consultation | Quality of Life : EORTC QLQ-C30 Scores | Financial difficulties - 5 months | 15.5 scores on a scale |
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 : * Anxiety * Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)
Time frame: At baseline and 5 months
Population: * At baseline, 2 patients did not complete the Anxio-depressive troubles questionnaire~* At 5 months ,1 patient did not complete the Anxio-depressive troubles questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Psychological and Social Consultation | Anxio-depressive Troubles : HAD Scale Scores | Anxiety score - 5 months | 8 scores on a scale |
| Psychological and Social Consultation | Anxio-depressive Troubles : HAD Scale Scores | Depression score - Baseline | 7.0 scores on a scale |
| Psychological and Social Consultation | Anxio-depressive Troubles : HAD Scale Scores | Depression score - 5 months | 6.5 scores on a scale |
| Psychological and Social Consultation | Anxio-depressive Troubles : HAD Scale Scores | Anxiety score - Baseline | 10.0 scores on a scale |
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 : * Behavioural * Emotional * Sensory * Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue
Time frame: At baseline and 5 months
Population: * At baseline:~ * 2 patients have missing data for the scores 'Emotional dimension', Behavioural dimension' and 'Sensory dimension'~ * 3 patients have missing data for the score 'Cognitive-mood dimension'~ * 3 patients finally have missing data for 'Total Score Fatigue Scale'~* At 5 months, 1 patient did not complete the Tiredness questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Emotional dimension - Baseline | 5.4 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Emotional dimension - 5 months | 5.7 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Sensory dimension - Baseline | 4.2 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Behavioural dimension - 5 months | 4.7 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Behavioural dimension - Baseline | 5.3 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Sensory dimension - 5 months | 4.0 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Cognitive-mood dimension - Baseline | 4.8 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Cognitive-mood dimension - 5 months | 3.9 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Total Score Fatigue Scale - Baseline | 5.2 scores on a scale |
| Psychological and Social Consultation | Tiredness : Piper MFI-20 Scale Scores | Total Score Fatigue Scale - 5 months | 4.7 scores on a scale |