NCT03302767: CAP'ONCO

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

Completed NA Results posted Last updated 4 May 2021

What this trial tests

NA trial testing Psychological and Social Consultation in Cancer in 29 participants. Completed in 27 June 2018.

Timeline

7 August 2017

Primary endpoint
27 June 2018

27 June 2018

Quick facts

Lead sponsor	Institut Bergonié
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	29
Start date	7 August 2017
Primary completion	27 June 2018
Estimated completion	27 June 2018
Sites	1 location across France

Drugs / interventions tested

• Psychological and Social Consultation

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Institut Bergonié — full company profile →

Who can join

Adults 25 to 55, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quality of Life : EORTC QLQ-C30 Scores Primary · 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.

Global health status/ quality of life - Baseline

Group	Value	95% CI
Psychological and Social Consultation	61.0	54.3 – 67.7

Global health status/ quality of life - 5 months

Group	Value	95% CI
Psychological and Social Consultation	70.8	66.1 – 75.5

Physical functioning - Baseline

Group	Value	95% CI
Psychological and Social Consultation	82.9	78.8 – 86.9

Physical functioning - 5 months

Group	Value	95% CI
Psychological and Social Consultation	83.2	78.7 – 87.6

Role functioning - Baseline

Group	Value	95% CI
Psychological and Social Consultation	72.6	63.6 – 81.6

Role functioning - 5 months

Group	Value	95% CI
Psychological and Social Consultation	78.6	70.2 – 87.0

Emotional functioning - Baseline

Group	Value	95% CI
Psychological and Social Consultation	61.0	51.3 – 70.7

Emotional functioning - 5 months

Group	Value	95% CI
Psychological and Social Consultation	67.0	57.9 – 76.0

Cognitive Complaints : FACT Cog Scale Scores Primary · 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.

Perceived Cognitive Impairment - Baseline

Group	Value	95% CI
Psychological and Social Consultation	39	8 – 69

Perceived Cognitive Impairment - 5 months

Group	Value	95% CI
Psychological and Social Consultation	50.5	7 – 72

Impact on quality of life - Baseline

Group	Value	95% CI
Psychological and Social Consultation	8	0 – 16

Impact on quality of life - 5 months

Group	Value	95% CI
Psychological and Social Consultation	14.0	0 – 16

Comments from others - Baseline

Group	Value	95% CI
Psychological and Social Consultation	15	5 – 16

Comments from others - 5 months

Group	Value	95% CI
Psychological and Social Consultation	16	3 – 16

Perceived Cognitive Skills - Baseline

Group	Value	95% CI
Psychological and Social Consultation	13	3 – 25

Perceived Cognitive Skills - 5 months

Group	Value	95% CI
Psychological and Social Consultation	17.5	0 – 27

Professional Recovery Scale Scores Primary · 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

Work and administrative process - Baseline

Group	Value	95% CI
Psychological and Social Consultation	58	44 – 73

Work and administrative process - 5 months

Group	Value	95% CI
Psychological and Social Consultation	61	34 – 80

Positioning in relation to the job-post-mission - Baseline

Group	Value	95% CI
Psychological and Social Consultation	40.5	13 – 75

Positioning in relation to the job-post-mission - 5 months

Group	Value	95% CI
Psychological and Social Consultation	50	10 – 73

Emotion and work - Baseline

Group	Value	95% CI
Psychological and Social Consultation	58.5	28 – 88

Emotion and work - 5 months

Group	Value	95% CI
Psychological and Social Consultation	60	33 – 91

Labour relations - Baseline

Group	Value	95% CI
Psychological and Social Consultation	55	11 – 90

Labour relations - 5 months

Group	Value	95% CI
Psychological and Social Consultation	59	28 – 90

Tiredness : Piper MFI-20 Scale Scores Secondary · 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

Emotional dimension - Baseline

Group	Value	95% CI
Psychological and Social Consultation	5.4	1.6 – 9.8

Behavioural dimension - 5 months

Group	Value	95% CI
Psychological and Social Consultation	4.7	0.5 – 9.2

Behavioural dimension - Baseline

Group	Value	95% CI
Psychological and Social Consultation	5.3	0.0 – 9.7

Emotional dimension - 5 months

Group	Value	95% CI
Psychological and Social Consultation	5.7	2.0 – 9.8

Sensory dimension - Baseline

Group	Value	95% CI
Psychological and Social Consultation	4.2	0.6 – 7.6

Sensory dimension - 5 months

Group	Value	95% CI
Psychological and Social Consultation	4.0	0.8 – 7.2

Cognitive-mood dimension - Baseline

Group	Value	95% CI
Psychological and Social Consultation	4.8	0.5 – 7.7

Cognitive-mood dimension - 5 months

Group	Value	95% CI
Psychological and Social Consultation	3.9	0.3 – 6.3

Anxio-depressive Troubles : HAD Scale Scores Secondary · 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)

Anxiety score - Baseline

Group	Value	95% CI
Psychological and Social Consultation	10.0	1 – 19

Anxiety score - 5 months

Group	Value	95% CI
Psychological and Social Consultation	8	2 – 18

Depression score - Baseline

Group	Value	95% CI
Psychological and Social Consultation	7.0	4 – 18

Depression score - 5 months

Group	Value	95% CI
Psychological and Social Consultation	6.5	3 – 12

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.