CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology

NCT03302767 | Completed Results

• 2 other identifiers: IB2017-032017-A01251-52
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Oncology; Work Keeping; Social difficulties; Cognitive Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Tiredness : Piper MFI-20 Scale Scores

  At baseline and 5 months

• Anxio-depressive Troubles : HAD Scale Scores

  At baseline and 5 months

Study Arms (1)

Psychological and Social Consultation

EXPERIMENTAL

Psychological and Social Consultation

Other: Psychological and Social Consultation

Interventions

Psychological and Social Consultation OTHER

Psychological and Social Consultation at Baseline, during the study and at the end of follow-up

Psychological and Social Consultation

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Patient deprived of liberty or subject to a legal protection measure
• History of cancers
• Cerebral pathology and / or brain metastasis

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Véronique GERAT-MULLER
• Organization: Institut Bergonié

v.gerat-muller@bordeaux.unicancer.fr

0556337839

Study Officials

• Véronique GERAT-MULLER, PhD

  Institut Bergonié - Supportive Oncology Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: October 5, 2017
• Study Start: August 7, 2017
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)