- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268378
Supervision of Clinicians in Oncology by Psycho-oncologists : Evaluation (SCOPE)
Efficacy of Supervision of Oncology/Haematology Clinicians by Psycho-oncologists: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Vaud
-
Lausanne, Canton of Vaud, Switzerland, 1011
- Psychiatrie de liaison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physician or nurse in oncology or hematology
- Specialized in medical oncology or hematology
Exclusion Criteria:
- Participation to individual supervision by psycho-oncologists as part of the following training courses: CAS in psycho-oncology and course "Mieux Commu iquer"
- Participated in a study involving supervision by psycho-oncologists
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervision group (SPV)
As baseline assessments (T0), participants will complete the Maslach Burnout Inventory (MBI) and 5-day clinical situation recordings (measuring supervisee's reflexivity) in which they describe a clinical situation that has remained in their mind during the day. Each participant will then take part in four 60 min clinician-centred supervision sessions (bi-monthly supervisions). During each supervision, (i) clinicians' feelings toward the patients presented will be measured with the Feeling Word Checklist (FWC-58) at the beginning and end of each session, and (ii) specific aspect and the overall quality of the supervision wil be assessed with a 4-item ad-hoc questionnaire for both supervisee and the supervisor. Assessments performed at T0 will be repeated after the 2-month intervention (T1). Finally, the MBI will be administered at follow-up assessments 3 months (FU3) and 6 months (FU6) after T1. |
In the first and thrid sessions, supervisees will comprehensively describe a clinical situation with a patient, which strongly affected them in a very negative way (e.g., feelings of rejection, anxiety, anger), or even lead to words (e.g., outbursts, impoliteness, cynicism) and actions (e.g., avoidance of the patient, forgetting appointments, deviation from good medical practice). In the second and fourth sessions, the same proceeding takes place, with the exception that participants are invited to present a clinical encounter with a patient, which strongly affected them in a very positive way (e.g., feelings of intense closeness, sympathy, pronounced mourning after the patient's death), or even lead to words (e.g., self-disclosure, discussing private information, compliments) and actions (e.g., special favours, difficulties to end treatment, deviation from good medical practice). |
|
No Intervention: Waiting-control group (CTRL)
As baseline assessments (T0), participants will complete the Maslach Burnout Inventory (MBI) and 5-day clinical situation recordings (measuring supervisee's reflexivity). The clinical situation recordings consist of describing a clinical situation that has remained in the clinician's mind during the day. They will then not receive supervisions during the 2-month waiting period. Assessments will be repeated after the 2-month waiting period (T1: MBI and 5-day clinical situation recordings) and follow-up evaluations with the MBI will take place at 3 months (FU3) and 6 months (FU6). After the trial period (i.e., after FU6), participants in this arm will be offered the opportunity to reveice the intervention. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Supervisee's reflexivity (qualitative classification)
Time Frame: Baseline (T0) and 2 months post-baseline (i.e., T1: after the 2 months of supervision for the SPV group or 2 months waiting period for the CTRL group)
|
Reflexivity will be assessed with the reflexivity indicator, a 4-level framework for classifying clinicians' narratives identified in the 5-day clinical situation recordings. This indicator has been developped in a previous study (in preparation) with the following level:
|
Baseline (T0) and 2 months post-baseline (i.e., T1: after the 2 months of supervision for the SPV group or 2 months waiting period for the CTRL group)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout (questionnaire)
Time Frame: Baseline (T0), 2 months post-baseline (T1), 3 months follow-up (FU3) and 6 months follow-up (FU6)
|
The Maslach Burnout Inventory (MBI) will measure the burnout level using its 22 items divided into three scales: emotional exhaustion, depersonalization, and personal accomplishment, rated on a 6-point scale (with 0 = never, and 6 = every day).
Scores for each scale are obtained by summing the responses of the corresponding items.
|
Baseline (T0), 2 months post-baseline (T1), 3 months follow-up (FU3) and 6 months follow-up (FU6)
|
|
Feeling towards patients (questionnaire)
Time Frame: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
|
For the SPV group only, clinicians' feelings towards presented patients will be measured with the Feeling Word Checklist (FWC; 58 items), a self-report questionnaire, prior and immediately after each supervison session.
Clinicians are invited to indicate if and to what extent (5 point rating scale with 0 = not at all, and 4 = very much) the feeling described through the words are experienced regarding a given patient.
We will use a translated version (french version) of the FWC.
|
From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
|
|
Supervision assessment (questionnaire)
Time Frame: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
|
For the SPV group only, specific aspects and the overall quality of each supervision session will be assessed using a 4-item ad-hoc questionnaire completed by both the supervisee and the supervisor. The first part evaluates specific aspects of the supervision (3 items) on a 5-point Likert scale ranging from "not true at all" to "absolutely true", while the second part assesses the overall quality of the session on a 5-point scale from "unsatisfactory" to "exceptionally satisfactory". A global score, calculated by summing all responses, reflects overall satisfaction with the supervision. . |
From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCOPE
- KLS-6188-08-2024 (Other Grant/Funding Number: Ligue suisse contre le cancer)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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