- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03302767
CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology (CAP'ONCO)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Bordeaux, Frankrike, 33076
- Institut Bergonié
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Psychological and Social Consultation
|
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quality of Life : EORTC QLQ-C30 Scores
Tidsram: 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. |
At baseline and 5 months
|
Cognitive Complaints : FACT Cog Scale Scores
Tidsram: 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 :
|
At baseline and 5 months
|
Professional Recovery Scale Scores
Tidsram: 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 :
|
At baseline and 5 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tiredness : Piper MFI-20 Scale Scores
Tidsram: 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 :
|
At baseline and 5 months
|
Anxio-depressive Troubles : HAD Scale Scores
Tidsram: 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 :
|
At baseline and 5 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Véronique GERAT-MULLER, PhD, Institut Bergonié - Supportive Oncology Care
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IB2017-03
- 2017-A01251-52 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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