CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology
Phase: NA
Conditions: Cancer
Sponsor: Institut Bergonié

MULTIDISCIPLINARY CONSULTATION TO SUPPORT 
RETURNING TO WORK AFTER CANCER TREATMENTS 
CAP’Onco study 
Coordinator – Principal investigator: 
Scientific manager 
Research and Clinical Epidemiology Unit 
Protocol editing committee 
PROMOTER 
INSTITUT BERGONIÉ 
 
 
 
 
 
Version no. 1.0 of 04/05/2017 – N°IB2017‐03 
Interventional research protocol involving people (category 2 for minimal 
risks and obligations) 
ID‐RCB no. 2017‐A01251‐52 
This research receives support from the BRIO integrated oncology 
research site (SIRIC) 
 
 
Ms Véronique GERAT‐MULLER 
  DISSPO CARE Department 
Psychologist, PhD 
 
Institut Bergonié 
Psychopathology and neuropsychology 
229, cours de l’Argonne – 33076 BORDEAUX Cedex 
Phone: +33 (0)556 337 839 – Fax: +33 (0)556 333 330 
E‐mail: v.gerat‐muller@bordeaux.unicancer.fr 
 
Ms Guilaine WILKINS 
Social care framework 
Institut Bergonié 
 
Prof. Simone MATHOULIN‐PELISSIER, Head of the unit 
Institut Bergonié 
Dr Stéphanie HOPPE, doctor/epidemiologist 
Institut Bergonié 
 
 
Ms Véronique GERAT‐MULLER, Psychologist, PhD 
Institut Bergonié 
Ms Guilaine WILKINS, Social care framework 
Institut Bergonié 
Prof. Ivan KRAKOWSKI, Oncologist 
Coordinator of the DISSPO CARE treatment support department 
 
Institut Bergonié 
Dr Odile DUGUEY‐CACHET, 3C coordinating doctor 
Institut Bergonié 
Ms Pauline BEAUFRÈRE, Head of the clinical research management unit 
Institut Bergonié 
Dr Stéphanie HOPPE, Doctor/epidemiologist 
Institut Bergonié 
Ms Véronique BROUSTE, Statistician/Data manager 
Institut Bergonié 
 
 

Institut Bergonié 
CAP’Onco protocol 
RES_CAP’Onco_version 1.0 of 04/05/2017 
Page 2 of 7 
 
 
 
Summary 
 
Title of the study 
CAP’ONCO 
Measure to support returning to work 
Coordinator 
Ms GERAT‐MULLER Véronique, PhD 
Clinical psychologist 
Psychopathology/Neuropsychology 
Scientific 
manager 
Ms WILKINS Guilaine, social care framework 
Number of centres 
planned 
Single-centre Institut Bergonié study 
Category 
Research involving people that includes only minimal risks and obligations (Article 
L1121‐1 2° of the French Public Health Code (Code de la Santé Publique) 
Topic 
Providing support when returning to work during and after cancer treatments. 
− social topic 
− psychological/neuropsychological topic 
Target group 
Patients who are living in Gironde, receiving follow-up care at the Institut Bergonié 
for cancer and in employment at the time of their diagnosis 
Justification 
for the study 
1. Surviving cancer 
 
Improving the survival rate: cancer is becoming chronic (growing number of 
people affected by and living with the disease) 
 
Cancer concerns more and more people who are working and have a long 
professional career ahead of them. 
 
Reintegration into the workplace for those affected by cancer is an objective 
of each of the Cancer Plans. 
2. Professional life and cancer 
Of those who are affected by cancer in France every year, one third are working at 
the time of diagnosis. 
(DREES study Corroller‐Soriano et al., updated in 2014 – ALD1 and VINCAN2 studies) 
 
82% of those interviewed aged 18 to 57 are in employment at the time of 
diagnosis. 
 
This number became 61.3% two years later. 
 
15% of patients do not take a break from working. 
 
12% were on sick leave two years after diagnosis. 
 
Feelings of isolation, rejection or discrimination in family, social and 
professional circles. 
3. The Institut Bergonié’s first action with regard to this issue (“Coordination du 
parcours de soins pendant et après les traitements” (“Coordination of treatment 
path during and after treatment”) (2012) – national INCA call of projects), with 
conclusions that highlight: 
 
The difficulties for some patients who are anticipating returning to work 
during the treatment stage. 
 
Isolation and lack of information for patients who are faced with multiple 

Institut Bergonié 
CAP’Onco protocol 
RES_CAP’Onco_version 1.0 of 04/05/2017 
Page 3 of 7 
 
 
 
measures for readjusting to work. 
 
A lack of cooperation between medical professionals with different 
authorities (specialist doctors and general practitioners, consultants and 
occupational health doctors), thus leading to contradictory guidance from 
these professionals. 
4. A major factor in patient anxiety with regard to returning to work: cognitive 
problems 
 
the literature shows psychological difficulties with cognitive functions 
disrupted by chemo brain. 
 
memory of work, attention, episodic memory, executive functions and 
processing speed are affected. 
 
the impact of the indication and/or toxicity of treatments lead to cognitive 
after-effects that are significant and damaging to varying levels, altering 
quality of life and thus the return to work. 
Methodology 
used 
Exploratory study 
Objectives 
Enabling patients to receive active, practical and strategic support for returning to 
work over the course of treatment. 
Exploring the provision of the measure in terms of quality of life and motivation in 
returning to work, with the aim of also proposing an objective evaluation tool in 
order to confirm the relevance of a model for supporting patients treated for cancer 
over the course of their overall treatment. 
Our hypothesis is that early, lasting and multimodal support enables improvement in 
the patient’s quality of life, improvement in cognitive complaint and strengthening 
professional motivation. 
Checking the practicability of the measure. Our hypothesis is that such a measure is 
feasible, helpful, easily accessible and recognised as being useful by patients. 
Inclusion criteria 
 Patients receiving follow-up care at Institut Bergonié 
 Signed information consent form 
 Patients who are members of a French social security scheme in compliance 
with Article L1121‐11 of the French Public Health Code (Code de la Santé 
Publique) 
 Between 25 and 55 years old 
 Living in Gironde 
 Working at time of diagnosis 
 Treated for – breast cancer 
− non-cerebral Hodgkin or non-Hodgkin lymphoma 
− testicular cancer 
 CURATIVE treatment 
 At any stage of treatment 
Exclusion criteria 
 Patient deprived of liberty or the subject of a legal protection measure 
 Medical history of cancer 
 Cerebral pathology and/or cerebral metastasis 
Roll-out of the 
study 
1. Inclusion: Social and psychology assistant: 
− 
Gathering the consent forms 
− 
Execution of the evaluation scales: 
− 
QLQ‐C30 version 3, Piper Fatigue Scale, Hospital Anxiety and Depression 

Institut Bergonié 
CAP’Onco protocol 
RES_CAP’Onco_version 1.0 of 04/05/2017 
Page 4 of 7 
 
 
 
Scale (HADS), cognitive complaint scale (French FACT‐COG version 3), 
motivation to return to work scale (not validated – IB doc) 
− 
Reinstating a schedule for the COGIT’Onco and TIC’Onco workshops 
− 
Proposing a date for a neuropsychological assessment (STROOP test ‐ GREFEX 
array (2001), Trail Making Test ‐ GREFEX array (2001), Baddeley’s double test, 
Cardebat et al. verbal fluency test, (1990) ‐ GREFEX array (2001), Rey figure 
test, memory of figures ‐ Wechsler Adult Intelligence Scale (4th edition), 
Symbols and Code ‐ 16-item “Épreuve de rappel libre/rappel indicé” (French 
adaptation of the Free and Cued Selective Reminding test) ‐ Grober & 
Buschke test, 1987, TAP by Zimmerman & Fimm. 
− 
Proposing a social assessment. 
A medical questionnaire will be completed on inclusion (on the basis of the 
medical file) 
2. Proposing access to an individual social and/or psychological assessment 
and/or follow-up 
3. In this CAP’Onco measure, the patient can take part in 2 workshops: 
The TIC’Onco workshop is a collective information time, an informative 
meeting shared with an unrestricted patient group 
The COGIT'Onco workshop is a re-education workshop on post-treatment 
cognitive problems. The patient is enrolled in the workshops of their choice. 
They can participate in as many workshops as they like. There is no obligation 
or limitation to a particular process. 
After participating, there will be an evaluation of the workshop(s) visited. 
4. the patient will be seen again 5 months after the first consultation: Social 
and psychology assistant. 
Execution of the evaluation scales: QLQ‐C30 version 3, Piper Fatigue Scale, 
Hospital Anxiety and Depression Scale (HADS), cognitive complaint scale 
(French FACT‐COG version 3), motivation to return to work scale (not 
validated – IB doc), responses to the workshop evaluation questionnaires and 
the questionnaire on general satisfaction with the measure, questionnaire on 
social and medical situation at the end of the measure. 
Evaluation 
criteria 
Primary evaluation criteria 
1. Efficacy of the intervention felt by the patient in terms of improvement at 5 
months on quality of life, cognitive complaint and initial cognitive problems 
and professional motivation 
the CAP’Onco intervention will be judged effective if one of the following conditions is 
observed at 5 months in the CAP’Onco group: 
− 
Improvement in the quality of life and no deterioration of cognitive complaint 
and professional motivation 
− 
Improvement in the cognitive complaint and no deterioration in the quality of 
life and professional motivation 
− 
Improvement in professional motivation and no deterioration in the quality of 
life and cognitive complaint 
OR, if we do a comparison and see average scores that are significantly more positive 
for quality of life and professional motivation during the visit at 5 months. 
[Significant improvement in score: significant average difference between the scores at T0 and T1‐5 months 
afterwards] 

Institut Bergonié 
CAP’Onco protocol 
RES_CAP’Onco_version 1.0 of 04/05/2017 
Page 5 of 7 
 
 
 
Secondary evaluation criteria 
2. Patient satisfaction: according to several scores 
− 
satisfaction 
score 
for 
psychological/
neuropsychological 
consultations  
− 
satisfaction score for social consultations 
− 
satisfaction score for COGIT’Onco workshops 
− 
satisfaction score for TIC’Onco workshops 
Patient satisfaction will be judged as good if the evaluation score for consultations, 
workshops and the general measure is higher than 20 for the TIC’Onco and 
COGIT'Onco workshops and higher than 4 for the overall CAP’Onco measure. 
3. Neuropsychological, emotional and asthenia evaluations 
− 
Scores for the proposed neuropsychological assessment tests 
− 
Score for anxiety and depression-related problems 
− 
Score for the fatigue scale 
4. Practicability and flexibility of the measure for receiving the patient 
− 
period for arranging the first consultation: The reactivity of the measure will 
be judged as good if the period between the patient giving consent and the 
multidisciplinary consultation is less than 3 weeks. 
− 
Number of psychology/neuropsychology consultations 
− 
Number of social consultations 
− 
Number of participants in the COGIT’Onco workshops 
− 
Number of participants in the TIC’Onco workshops 
− 
Period between starting treatment and inclusion in the measure 
Planned number of 
patients in the 
study 
30 patients 
Planned study 
duration 
Inclusion period: 2 months 
Duration of follow-ups and evaluations: 5 
months Duration of participation for a 
patient: 5 months. Study duration: 7 
months. 
End of the study: 5 months after evaluating the last patient. 
Statistical 
and data 
analyses 
considered 
Exploratory and descriptive study: use of multidimensional, exploratory statistical 
data analysis techniques with the objective of a descriptive study (method, median, 
percentile, average, standard deviation, comparing averages) and a quantitative 
analysis of semi-structured interviews concerning motivation to return to work. 
Anticipate
d impacts 
Returning to work is a process that can bring up new vulnerability factors. The 
anticipated impact will be that this measure is noted, recognised and identified by 
consultants as: 
− a resource for patients who are experiencing or anticipate difficulties linked to 
returning to work. 
− Potential use in specific situations requires the expertise of all involved. 
This study could also make it possible to develop a measure that can be reproduced in 
different regions in connection with local partners and actors in the world of work. 
This project is in line with the primary purpose of treatment support: supporting the 
patient and their family and friends at every stage of their treatment path and 
afterwards.