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

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ClinicalTrials.gov Identifier: NCT03302767
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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.


Condition or disease Intervention/treatment Phase
Cancer Other: Psychological and Social Consultation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: To complete
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : June 27, 2018
Estimated Study Completion Date : June 27, 2018

Arm Intervention/treatment
Experimental: Psychological and Social Consultation
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




Primary Outcome Measures :
  1. Quality of life [ Time Frame: At baseline ]
    QLQ-C30 version3

  2. Tiredness [ Time Frame: At baseline ]
    Piper MFI-20 revised scale

  3. Anxio-depressive troubles [ Time Frame: At baseline ]
    Hospital Anxiety and Depression scale

  4. Cognitive complaints [ Time Frame: At baseline ]
    French FACT-Cog version 3

  5. Career motivation [ Time Frame: At baseline ]
    scale constructed for the needs of this exploratory research. This tool has for vocation a later validation.

  6. Satisfaction questionnaire for TIC and Cogit'Onco [ Time Frame: At baseline ]
  7. General satisfaction questionnaire [ Time Frame: At baseline ]
  8. Quality of life [ Time Frame: At 5 months ]
    QLQ-C30 version3

  9. Tiredness [ Time Frame: At 5 months ]
    Piper MFI-20 revised scale

  10. Anxio-depressive troubles [ Time Frame: At 5 months ]
    Hospital Anxiety and Depression scale

  11. Cognitive complaints [ Time Frame: At 5 months ]
    French FACT-Cog version 3

  12. Career motivation [ Time Frame: At 5 months ]
    scale constructed for the needs of this exploratory research. This tool has for vocation a later validation.

  13. Satisfaction questionnaire for TIC and Cogit'Onco [ Time Frame: At 5 months ]
  14. General satisfaction questionnaire [ Time Frame: At 5 months ]
  15. Alertness [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  16. Substained Attention/Concentration [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  17. Divided attention [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  18. Cognitive flexibility.1 [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  19. Cognitive flexibility.2 [ Time Frame: At baseline ]
    Trail Making Test - GREFREX (2001)

  20. Inhibition / control.1 [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  21. Inhibition/Control.2 [ Time Frame: At baseline ]
    Stroop - GREFEX (2001)

  22. Vigilance [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1) Zimmerman et Fimm (1994) French adaptation M.Leclercq

  23. Memory learning. [ Time Frame: At baseline ]
    RL-RI 16 (French adaptation of Free and Cued Selective Reminding) GROBER & BUSCKE (1987)

  24. Working memory.1 [ Time Frame: At baseline ]
    WAIS working memory figure - Wechsler Adult Intelligence Scale (WAIS IV)

  25. Working memory.2 [ Time Frame: At baseline ]
    TAP Test of Attentional Performance (TAP2.3.1)

  26. Verbal Fluency [ Time Frame: At baseline ]
    Verbal Fluency Test - Cardebat et al. (1990)

  27. Data processing speed [ Time Frame: At baseline ]
    WAIS Symbols - Wechsler Adult Intelligence Scale (WAIS IV)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302767


Contacts
Contact: Véronique GERAT-MULLER, PhD +556333333 v.gerat-muller@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD,PhD s.mathoulin@bordeaux.unicancer.fr

Locations
France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Véronique GERAT-MULLER, PhD         
Principal Investigator: Véronique GERAT-MULLER, PhD         
Sub-Investigator: Guilaine WILKINS         
Sponsors and Collaborators
Institut Bergonié

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03302767     History of Changes
Other Study ID Numbers: IB2017-03
2017‐A01251‐52 ( Other Identifier: ANSM )
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Bergonié:
Oncology
Work Keeping
Social difficulties
Cognitive Disorders