Healthy ParticipantsSCOPENCT07268378
Supervision of Clinicians in Oncology by Psycho-oncologists : Evaluation
A study testing Supervision session in people with Healthy Participants, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Communication in the oncology setting involves cognitive as well as emotional challenges for both clinicians and patients, and interactional dimensions that emerge in their encounter. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Supervision session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Aug 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physician or nurse in oncology or hematology
- Specialized in medical oncology or hematology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Supervision of Oncology/Haematology Clinicians by Psycho-oncologists: A Randomized Controlled Trial
Communication in the oncology setting involves cognitive as well as emotional challenges for both clinicians and patients, and interactional dimensions that emerge in their encounter. Supervision of oncology/haematology clinicians by psycho-oncologists is one of the most frequently used tools, which aims to enhance their communicative and relational competences, and at the same time to support them in their daily clinical work. However, little is known regarding its impact and how the supervisory process acts upon clinicians. This study thus aims to evaluate the efficacy of four 1-hour supervision sessions following a clinician-centred format, which allows supervisors to rapidly access supervisees' own difficulties in the encounter with certain patients. In addition, the supervisory process will be examined qualitatively by analysing in-depth audio-taped supervision sessions. The focus of analysis will be "what works" and "what does not". If beneficial effects are found, clinician-centred supervision -- thanks to its focused and time saving format -- could be realistically implemented for nurses and physicians working in the oncology and haematology settings. Effects are expected on clinicians' capacity to reflect on challenging encounters with patients, on potential negative feelings towards patients, and on clinicians' professional well-being. The clinician-centred supervision format could be easily taught to psycho-oncologists who wish to start supervising haematology and oncology clinicians. Clinicians who are less preoccupied with themselves, or with negative feelings towards their patients, have more supportive relationships with them, which is of utmost importance in critical settings such as oncology and haematology.
- Conditions
- Healthy Participants
- Being tested
- Supervision session
- Keywords
- supervision, clinician, oncology, hematology, formative function, restorative function, normative function, reflexivity, feelings towards patients, burnout
- Medical subject headings
- Neoplasms, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervision sessionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Supervision group (SPV) | Experimental | 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. Receives: Other: Supervision session |
| Waiting-control group (CTRL) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Supervisee's reflexivity (qualitative classification)
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:
- Level 0 - Describing: clinicians report medical and basic psychosocial facts, like a referral note.
- Level 1 - Noticing: they mention interactions and resonate with patients' emotions but without deeper links.
- Level 2 - Recognizing: they reflect on their interaction style, noting institutional/professional influences, and ask "what if I could do this consultation again?" to improve future practice.
- Level 3 - Making sense: they analyze what happened, what could have been done differently, and what to do next time. Here, clinicians derive general principles, extending insights beyond the single case and shifting perspective.
Measured: 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 outcomes (3)
Feeling towards patients (questionnaire)
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.
Measured: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
Burnout (questionnaire)
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.
Measured: Baseline (T0), 2 months post-baseline (T1), 3 months follow-up (FU3) and 6 months follow-up (FU6)
Supervision assessment (questionnaire)
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.
.
Measured: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start11 Aug 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in an intervention (Supervision group: SPV) group with supervision sessions and a waiting-control (CTRL) group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Principal investigator, Friedrich Stiefel, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268378
- Sponsor's protocol ID
- SCOPE
- Other IDs
- KLS-6188-08-2024
- Acronym
- SCOPE
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supervision of Oncology/Haematology Clinicians by Psycho-oncologists: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07268378
- Acronym / sponsor ID
- SCOPE / SCOPE
- Conditions
- Healthy Participants
- Keywords
- supervision, clinician, oncology, hematology, formative function, restorative function, normative function, reflexivity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Communication in the oncology setting involves cognitive as well as emotional challenges for both clinicians and patients, and interactional dimensions that emerge in their encounter. Supervision of oncology/haematology clinicians by psycho-oncologists is one of the most frequently used tools, which aims to enhance their communicative and relational competences, and at the same time to support them in their daily clinical work. However, little is known regarding its impact and how the supervisory process acts upon clinicians. This study thus aims to evaluate the efficacy of four 1-hour supervision sessions following a clinician-centred format, which allows supervisors to rapidly access supervisees' own difficulties in the encounter with certain patients. In addition, the supervisory process will be examined qualitatively by analysing in-depth audio-taped supervision sessions. The focus of analysis will be "what works" and "what does not". If beneficial effects are found, clinician-centred supervision -- thanks to its focused and time saving format -- could be realistically implemented for nurses and physicians working in the oncology and haematology settings. Effects are expected on clinicians' capacity to reflect on challenging encounters with patients, on potential negative feelings towards patients, and on clinicians' professional well-being. The clinician-centred supervision format could be easily taught to psycho-oncologists who wish to start supervising haematology and oncology clinicians. Clinicians who are less preoccupied with themselves, or with negative feelings towards their patients, have more supportive relationships with them, which is of utmost importance in critical settings such as oncology and haematology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in an intervention (Supervision group: SPV) group with supervision sessions and a waiting-control (CTRL) group.
| Arm | Type | Receives |
|---|---|---|
| Supervision group (SPV) | Experimental | Other: Supervision sessionAs 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. |
| Waiting-control group (CTRL) | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physician or nurse in oncology or hematology
- Specialized in medical oncology or hematology
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Supervision sessionIn 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). | Other | Supervision group (SPV) |
Primary outcome
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: * Level 0 - Describing: clinicians report medical and basic psychosocial facts, like a referral note. * Level 1 - Noticing: they mention interactions and resonate with patients' emotions but without deeper links. * Level 2 - Recognizing: they reflect on their interaction style, noting institutional/professional influences, and ask "what if I could do this consultation again?" to improve future practice. * Level 3 - Making sense: they analyze what happened, what could have been done differently, and what to do next time. Here, clinicians derive general principles, extending insights beyond the single case and shifting perspective.
3 secondary outcomes
Feeling towards patients (questionnaire)
Time frame: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
Burnout (questionnaire)
Time frame: Baseline (T0), 2 months post-baseline (T1), 3 months follow-up (FU3) and 6 months follow-up (FU6)
Supervision assessment (questionnaire)
Time frame: From supervision 1 to 4 during the 2-month intervention period (only for SPV group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervision session in people with Healthy Participants, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.