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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Psychological and Social Consultation

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychological and Social Consultation	Other: Psychological and Social Consultation; Psychological and Social Consultation at Baseline, during the study and at the end of follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 : 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.	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 : 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	At baseline and 5 months

Secondary Outcome Measures

Outcome Measure	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 : Behavioural; Emotional; Sensory; Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue	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 : 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)	At baseline and 5 months

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Principal Investigator: Véronique GERAT-MULLER, PhD, Institut Bergonié - Supportive Oncology Care

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Oncology; Cognitive Disorders; Work Keeping; Social difficulties
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IB2017-03; 2017-A01251-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No