CancerCAP'ONCONCT03302767

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

A study testing Psychological and Social Consultation in people with Cancer, run by Institut Bergonié at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Cancer
What is being tested?: Psychological and Social Consultation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteFrance
Study dates: 7 Aug 2017to 27 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Institut Bergonié
Bordeaux, 33076

Other trials in France

About this study

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.

Read the 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

Conditions: Cancer
Being tested: Psychological and Social Consultation
Keywords: Oncology, Work Keeping, Social difficulties, Cognitive Disorders
Medical subject headings: Neoplasms, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03302767
Study group	Role	What they receive
Psychological and Social Consultation	Experimental	Psychological and Social Consultation Receives: Other: Psychological and Social Consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: At baseline and 5 months

Secondary outcomes (2)

Tiredness : Piper MFI-20 Scale Scores
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
Measured: At baseline and 5 months
Anxio-depressive Troubles : HAD Scale Scores
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)
Measured: At baseline and 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201727 Jun 2018

First posted5 Oct 2017
Study start7 Aug 2017
Primary completion27 Jun 2018
Study completion27 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective study
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302767
Sponsor's protocol ID: IB2017-03
Other IDs: 2017-A01251-52
Acronym: CAP'ONCO
Status last verified: May 2021
First submitted: 12 May 2017
Last updated: 4 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology
ClinicalTrials.gov ID: NCT03302767
Acronym / sponsor ID: CAP'ONCO / IB2017-03
Conditions: Cancer
Keywords: Oncology, Work Keeping, Social difficulties, Cognitive Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Institut BergoniéUniversity, hospital or other
Study start: 7 Aug 2017 (actual)
Primary completion: 27 Jun 2018 (actual)
Study completion: 27 Jun 2018 (actual)
First posted: 5 Oct 2017 (actual)
Results: Posted 4 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective study

Arm	Type	Receives
Psychological and Social Consultation	Experimental	Other: Psychological and Social ConsultationPsychological and Social Consultation

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Patients attending the Institut Bergonié
Informed Consent signed.
Patients affiliated to a French social
living in Gironde
Professional activity at the time of diagnosis

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psychological and Social ConsultationPsychological and Social Consultation at Baseline, during the study and at the end of follow-up	Other	Psychological and Social Consultation

Primary outcome

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.
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.
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

2 secondary outcomes

Tiredness : Piper MFI-20 Scale Scores
Time frame: At baseline and 5 months
Anxio-depressive Troubles : HAD Scale Scores
Time frame: At baseline and 5 months

Results and safety

Results posted to the registry on 4 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Psychological and Social Consultation	29	29

Primary outcome: Quality of Life : EORTC QLQ-C30 Scores

Time frame: At baseline and 5 months. Mean (95% Confidence Interval). Unit: scores on a scale

Measure	Psychological and Social Consultation n = 29
Global health status/ quality of life - Baseline	61.0 (54.3 to 67.7)
Global health status/ quality of life - 5 months	70.8 (66.1 to 75.5)
Physical functioning - Baseline	82.9 (78.8 to 86.9)
Physical functioning - 5 months	83.2 (78.7 to 87.6)
Role functioning - Baseline	72.6 (63.6 to 81.6)
Role functioning - 5 months	78.6 (70.2 to 87.0)
Emotional functioning - Baseline	61.0 (51.3 to 70.7)
Emotional functioning - 5 months	67.0 (57.9 to 76.0)

Population analysed: * At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'. * At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients : * 1 patient has missing data for the scores 'Constipation' and 'Diarrhoea' * 1 another patient has missing data for the score 'Fatigue'

Primary outcome: Cognitive Complaints : FACT Cog Scale Scores

Time frame: At baseline and 5 months. Median (Full Range). Unit: scores on a scale

Measure	Psychological and Social Consultation n = 29
Perceived Cognitive Impairment - Baseline	39 (8 to 69)
Perceived Cognitive Impairment - 5 months	50.5 (7 to 72)
Impact on quality of life - Baseline	8 (0 to 16)
Impact on quality of life - 5 months	14.0 (0 to 16)
Comments from others - Baseline	15 (5 to 16)
Comments from others - 5 months	16 (3 to 16)
Perceived Cognitive Skills - Baseline	13 (3 to 25)
Perceived Cognitive Skills - 5 months	17.5 (0 to 27)

Population analysed: * At baseline, 2 patients did not complete the Cognitive complaints questionnaire * At 5 months, 1 patient did not complete the Cognitive complaints questionnaire

Primary outcome: Professional Recovery Scale Scores

Time frame: At baseline and 5 months. Median (Full Range). Unit: scores on a scale

Measure	Psychological and Social Consultation n = 29
Work and administrative process - Baseline	58 (44 to 73)
Work and administrative process - 5 months	61 (34 to 80)
Positioning in relation to the job-post-mission - Baseline	40.5 (13 to 75)
Positioning in relation to the job-post-mission - 5 months	50 (10 to 73)
Emotion and work - Baseline	58.5 (28 to 88)
Emotion and work - 5 months	60 (33 to 91)
Labour relations - Baseline	55 (11 to 90)
Labour relations - 5 months	59 (28 to 90)

Population analysed: * At baseline, 1 patient did not complete the Professional recovery questionnaire * At 5 months : * 3 patients have missing data for the scores 'Work and administrative process', 'Work and physical/intellectual conditions' and 'Privacy and work' * 4 patients have missing data for the scores 'Positioning in relation to the job-post-mission', 'Emotion and work' and 'Labour relations' * 1 patient has missing data for the score 'Return to work'

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychological and Social Consultation	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Véronique GERAT-MULLER, PhD principal investigator

Institut Bergonié - Supportive Oncology Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychological and Social Consultation in people with Cancer, run by Institut Bergonié at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life : EORTC QLQ-C30 Scores (time frame: At baseline and 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.