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Completed

NCT Number: NCT03302767

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

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.

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Key information

Conditions

Cancer Cognition Disorders Cognitive Dysfunction Mental Disorders Neoplasms Neurocognitive Disorders

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, 33076, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological and Social Consultation

Other

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

Primary outcomes

  1. Quality of Life : EORTC QLQ-C30 Scores

    Time frame: 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.

  2. Cognitive Complaints : FACT Cog Scale Scores

    Time frame: 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 :

    • 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.

  3. Professional Recovery Scale Scores

    Time frame: 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 :

    • 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

Secondary outcomes

  1. Tiredness : Piper MFI-20 Scale Scores

    Time frame: 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 :

    • Behavioural
    • Emotional
    • Sensory
    • Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue

  2. Anxio-depressive Troubles : HAD Scale Scores

    Time frame: 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 :

    • 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)

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: CAP'ONCO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2017
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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