Communication ProgramsNCT05842083
On-site Supportive Communication Training in Doctor-patient Communication
A study testing On-site supportive communication training in people with Communication Programs and Communication, Manual, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The goal of this randomized, controlled clinical trial is to test a new concept for communication skills training (on-site supportive communication training (on-site SCT) in cancer care. The study aims to determine the impact of on-site SCT on patients' rating of oncologists' communication abilities. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Communication Programs, Communication, Manual, Communication Research
- What is being tested?
- On-site supportive communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical doctors
- Employed at the Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark or Aalborg University Hospital, or Zealand University Hospital, Roskilde/Naestved.
- Work in the outpatient clinics at the participating departments
Who cannot join
- Doctors whose employment contracts will expire during the study and who do not plan to continue working at the department.
- Doctors who are not willing to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, University Hospital of Southern Denmark - Vejle Hospital
Vejle, 7100
About this study
Official title: On-site Supportive Communication Training in Doctor-patient Communication: A Randomized, Controlled Trial
The goal of this randomized, controlled clinical trial is to test a new concept for communication skills training (on-site supportive communication training (on-site SCT) in cancer care. The study aims to determine the impact of on-site SCT on patients' rating of oncologists' communication abilities.
Oncologists participating in the study will be randomly allocated to the intervention or control group. In the intervention group each doctor will have a total of three intervention days at intervals of 3-4 weeks. On an intervention day, a psychologist will sit in and observe doctor-patient consultations. After the first consultations, 30 minutes are allocated for feedback to the doctor by the psychologist. After the last consultation of the day, 60 minutes are allocated for thorough feedback and establishment of learning goals to focus on until the next intervention day. Doctor's in the control group will conduct communication as usual.
Read more
Researchers will compare the control and intervention groups to see if patients' rating of doctors' interpersonal and communication skills increase when the doctors have participated in on-site SCT. The 15-item Communication Assessment Tool (CAT) will be used.
It will also be investigated whether on-site SCT increases the doctors' rating of themselves in relation to communication efficacy and job satisfaction and decrease their experience of burnout.
Read the detailed description
Oncologists carry a heavy responsibility when delivering information to cancer patients and helping them navigate through decisions about life-altering treatments, survivorship, and end-of-life care. Comprehensive person-centered psychosocial cancer care should be adapted to the individual patient, which is obviously a challenging task (Dilworth, et al. 2014). Individualized and empathic communication, on the other hand, is of substantial importance to patient satisfaction, adherence to treatment, empowerment, and the ability to navigate in the disease trajectory (Gattellari, et al. 2001; Stewart 1995; Vogel, et al. 2009).
The quality of the communication in medical care has been shown to influence health outcomes, as it increases the risk of unnecessary treatment and is linked to insufficient pain relief and higher anxiety levels (Thorne, et al. 2005). Therefore, considerable effort has been dedicated to interventions that may improve the communication skills of healthcare professionals involved in cancer care (Moore, et al. 2018). The primary purpose has been to improve the quality of the doctor-patient-communication including the doctors' interpersonal skills.
Previous papers have suggested direct feedback on observed situations as an ideal method for improving communication skills (Anderson 2012; Burgess, et al. 2020), but to the best of our knowledge, no randomized clinical trials have used patient feedback during on-site training. Studies on communication skills training courses with recorded consultations/role-play have shown significant effect on key communication skills (Fallowfield, et al. 2002) and increased self-efficacy (Ammentorp, et al. 2007). Two studies have demonstrated long-term maintenance of acquired skills (Finset, et al. 2003; Gulbrandsen, et al. 2013). Until now, no effect on burnout has been demonstrated (Bragard, et al. 2010a; Bragard, et al. 2010b).
Clinical supervision and training aims to develop clinical practice and provide a protected space to allow an educational and reflective process to occur. Although there is still no empirical definition of the term supervision (Milne 2007), in 2004 Bernard and Goodyear defined it as "an intervention provided by a more senior member of a profession to a more junior member or members of that same profession"(Bernard 2004). On this premise, psychologists cannot formally supervise doctors and other terms must be used. In this project we therefore use the term "on-site supportive communication training" (on-site SCT) when referring to the intervention given by the psychologists.
Psychologists have a long tradition of working with communication, creating a reflective learning space, making observations and providing feedback. It is therefore highly relevant to use dedicated psychologists to investigate the effect of on-site SCT on the doctors' communication and on their experienced level of self-efficacy, satisfaction and burn-out.
- Conditions
- Communication Programs, Communication, Manual, Communication Research, Oncology, Doctor Patient Relation, Job Stress
- Being tested
- On-site supportive communication training
- Medical subject headings
- Communication, Manual Communication, Neoplasms, Occupational Stress, Burnout, Psychological, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site supportive communication trainingBehavioural
On-site supportive communication training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Each oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback. Receives: Behavioral: On-site supportive communication training |
| Control | No intervention | Oncologists in the control group will conduct consultations as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in rate of "Excellent" scores on the Communication Assessment Tool between the intervention and the control group.
Patients rate the doctor's communication skills right after the consultation.
Measured: 6 months
Secondary outcomes (3)
Change in oncologists' rating of own communication efficacy according to the "Self-efficacy in Health Communication" tool from before to after on-site communication training.
The Self-efficacy in Health Communication tool consists of 12 questions eliciting the healthcare professionals' perceived self-efficacy in communication with patients using a 10-point scale from "very uncertain" (1) to "very certain" (10).
Measured: 6 months
Change in oncologists' rating of burnout according to part 2 and 3 of the Copenhagen Burnout Inventory tool from before to after on-site communication training.
The reply options in relation to burnout range from 1 (To a very high degree/always), to 5 (To a very low degree/never-almost never)
Measured: 6 months
Change in oncologists' rating of job satisfaction from before to after on-site communication training.
Job satisfaction is measured in Denmark every other year at the nation-wide employee satisfaction survey, which survey offers a large amount of comparable data. Five items directly concerning job satisfaction will be extracted from the survey.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 May 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Communication ProgramsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oncologists will be randomized between the intervention and usual practice.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor
- Investigators
- Kerstin Kiis Antonsen, MD, Principal investigator, University Hospital of Southern Denmark - Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842083
- Sponsor's protocol ID
- On-site SCT
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dilworth S, Higgins I, Parker V, Kelly B, Turner J. Patient and health professional's perceived barriers to the delivery of psychosocial care to adults with cancer: a systematic review. Psychooncology. 2014 Jun;23(6):601-12. doi: 10.1002/pon.3474. Epub 2014 Feb 11.
PubMed 24519814Gattellari M, Butow PN, Tattersall MH. Sharing decisions in cancer care. Soc Sci Med. 2001 Jun;52(12):1865-78. doi: 10.1016/s0277-9536(00)00303-8.
PubMed 11352412Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
PubMed 7728691Vogel BA, Leonhart R, Helmes AW. Communication matters: the impact of communication and participation in decision making on breast cancer patients' depression and quality of life. Patient Educ Couns. 2009 Dec;77(3):391-7. doi: 10.1016/j.pec.2009.09.005. Epub 2009 Oct 1.
PubMed 19796910Thorne SE, Bultz BD, Baile WF; SCRN Communication Team. Is there a cost to poor communication in cancer care?: a critical review of the literature. Psychooncology. 2005 Oct;14(10):875-84; discussion 885-6. doi: 10.1002/pon.947.
PubMed 16200515Moore PM, Rivera S, Bravo-Soto GA, Olivares C, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database Syst Rev. 2018 Jul 24;7(7):CD003751. doi: 10.1002/14651858.CD003751.pub4.
PubMed 30039853Anderson PA. Giving feedback on clinical skills: are we starving our young? J Grad Med Educ. 2012 Jun;4(2):154-8. doi: 10.4300/JGME-D-11-000295.1.
PubMed 23730434Burgess A, van Diggele C, Roberts C, Mellis C. Feedback in the clinical setting. BMC Med Educ. 2020 Dec 3;20(Suppl 2):460. doi: 10.1186/s12909-020-02280-5.
PubMed 33272265Fallowfield L, Jenkins V, Farewell V, Saul J, Duffy A, Eves R. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):650-6. doi: 10.1016/S0140-6736(02)07810-8.
PubMed 11879860Ammentorp J, Sabroe S, Kofoed PE, Mainz J. The effect of training in communication skills on medical doctors' and nurses' self-efficacy. A randomized controlled trial. Patient Educ Couns. 2007 Jun;66(3):270-7. doi: 10.1016/j.pec.2006.12.012. Epub 2007 Mar 2.
PubMed 17337337Finset A, Ekeberg O, Eide H, Aspegren K. Long term benefits of communication skills training for cancer doctors. Psychooncology. 2003 Oct-Nov;12(7):686-93. doi: 10.1002/pon.691.
PubMed 14502593Gulbrandsen P, Jensen BF, Finset A, Blanch-Hartigan D. Long-term effect of communication training on the relationship between physicians' self-efficacy and performance. Patient Educ Couns. 2013 May;91(2):180-5. doi: 10.1016/j.pec.2012.11.015. Epub 2013 Feb 12.
PubMed 23414658Bragard I, Etienne AM, Merckaert I, Libert Y, Razavi D. Efficacy of a communication and stress management training on medical residents' self-efficacy, stress to communicate and burnout: a randomized controlled study. J Health Psychol. 2010 Oct;15(7):1075-81. doi: 10.1177/1359105310361992. Epub 2010 May 7.
PubMed 20453053Bragard I, Libert Y, Etienne AM, Merckaert I, Delvaux N, Marchal S, Boniver J, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Insight on variables leading to burnout in cancer physicians. J Cancer Educ. 2010 Mar;25(1):109-15. doi: 10.1007/s13187-009-0026-9.
PubMed 20082173Milne D. An empirical definition of clinical supervision. Br J Clin Psychol. 2007 Nov;46(Pt 4):437-47. doi: 10.1348/014466507X197415.
PubMed 17535535
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-site Supportive Communication Training in Doctor-patient Communication: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05842083
- Acronym / sponsor ID
- On-site SCT
- Conditions
- Communication Programs, Communication, Manual, Communication Research, Oncology, Doctor Patient Relation, Job Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Aalborg University Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 3 May 2023 (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.
The goal of this randomized, controlled clinical trial is to test a new concept for communication skills training (on-site supportive communication training (on-site SCT) in cancer care. The study aims to determine the impact of on-site SCT on patients' rating of oncologists' communication abilities.
Oncologists participating in the study will be randomly allocated to the intervention or control group. In the intervention group each doctor will have a total of three intervention days at intervals of 3-4 weeks. On an intervention day, a psychologist will sit in and observe doctor-patient consultations. After the first consultations, 30 minutes are allocated for feedback to the doctor by the psychologist. After the last consultation of the day, 60 minutes are allocated for thorough feedback and establishment of learning goals to focus on until the next intervention day. Doctor's in the control group will conduct communication as usual.
Researchers will compare the control and intervention groups to see if patients' rating of doctors' interpersonal and communication skills increase when the doctors have participated in on-site SCT. The 15-item Communication Assessment Tool (CAT) will be used.
It will also be investigated whether on-site SCT increases the doctors' rating of themselves in relation to communication efficacy and job satisfaction and decrease their experience of burnout.
Detailed description
Oncologists carry a heavy responsibility when delivering information to cancer patients and helping them navigate through decisions about life-altering treatments, survivorship, and end-of-life care. Comprehensive person-centered psychosocial cancer care should be adapted to the individual patient, which is obviously a challenging task (Dilworth, et al. 2014). Individualized and empathic communication, on the other hand, is of substantial importance to patient satisfaction, adherence to treatment, empowerment, and the ability to navigate in the disease trajectory (Gattellari, et al. 2001; Stewart 1995; Vogel, et al. 2009).
The quality of the communication in medical care has been shown to influence health outcomes, as it increases the risk of unnecessary treatment and is linked to insufficient pain relief and higher anxiety levels (Thorne, et al. 2005). Therefore, considerable effort has been dedicated to interventions that may improve the communication skills of healthcare professionals involved in cancer care (Moore, et al. 2018). The primary purpose has been to improve the quality of the doctor-patient-communication including the doctors' interpersonal skills.
Previous papers have suggested direct feedback on observed situations as an ideal method for improving communication skills (Anderson 2012; Burgess, et al. 2020), but to the best of our knowledge, no randomized clinical trials have used patient feedback during on-site training. Studies on communication skills training courses with recorded consultations/role-play have shown significant effect on key communication skills (Fallowfield, et al. 2002) and increased self-efficacy (Ammentorp, et al. 2007). Two studies have demonstrated long-term maintenance of acquired skills (Finset, et al. 2003; Gulbrandsen, et al. 2013). Until now, no effect on burnout has been demonstrated (Bragard, et al. 2010a; Bragard, et al. 2010b).
Clinical supervision and training aims to develop clinical practice and provide a protected space to allow an educational and reflective process to occur. Although there is still no empirical definition of the term supervision (Milne 2007), in 2004 Bernard and Goodyear defined it as "an intervention provided by a more senior member of a profession to a more junior member or members of that same profession"(Bernard 2004). On this premise, psychologists cannot formally supervise doctors and other terms must be used. In this project we therefore use the term "on-site supportive communication training" (on-site SCT) when referring to the intervention given by the psychologists.
Psychologists have a long tradition of working with communication, creating a reflective learning space, making observations and providing feedback. It is therefore highly relevant to use dedicated psychologists to investigate the effect of on-site SCT on the doctors' communication and on their experienced level of self-efficacy, satisfaction and burn-out.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Oncologists will be randomized between the intervention and usual practice.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: On-site supportive communication trainingEach oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback. |
| Control | No intervention | –Oncologists in the control group will conduct consultations as usual. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical doctors
- Employed at the Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark or Aalborg University Hospital, or Zealand University Hospital, Roskilde/Naestved.
- Work in the outpatient clinics at the participating departments
Key exclusion criteria (2 listed)
- Doctors whose employment contracts will expire during the study and who do not plan to continue working at the department.
- Doctors who are not willing to sign the informed consent form.
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 |
|---|---|---|
| On-site supportive communication trainingOn-site supportive communication training | Behavioural | Intervention |
Primary outcome
Difference in rate of "Excellent" scores on the Communication Assessment Tool between the intervention and the control group.
Time frame: 6 months
Patients rate the doctor's communication skills right after the consultation.
3 secondary outcomes
Change in oncologists' rating of own communication efficacy according to the "Self-efficacy in Health Communication" tool from before to after on-site communication training.
Time frame: 6 months
Change in oncologists' rating of burnout according to part 2 and 3 of the Copenhagen Burnout Inventory tool from before to after on-site communication training.
Time frame: 6 months
Change in oncologists' rating of job satisfaction from before to after on-site communication training.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 24519814Dilworth S, Higgins I, Parker V, Kelly B, Turner J. Patient and health professional's perceived barriers to the delivery of psychosocial care to adults with cancer: a systematic review. Psychooncology. 2014 Jun;23(6):601-12. doi: 10.1002/pon.3474. Epub 2014 Feb 11.
- Background: PubMed 11352412Gattellari M, Butow PN, Tattersall MH. Sharing decisions in cancer care. Soc Sci Med. 2001 Jun;52(12):1865-78. doi: 10.1016/s0277-9536(00)00303-8.
- Background: PubMed 7728691Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
- Background: PubMed 19796910Vogel BA, Leonhart R, Helmes AW. Communication matters: the impact of communication and participation in decision making on breast cancer patients' depression and quality of life. Patient Educ Couns. 2009 Dec;77(3):391-7. doi: 10.1016/j.pec.2009.09.005. Epub 2009 Oct 1.
- Background: PubMed 16200515Thorne SE, Bultz BD, Baile WF; SCRN Communication Team. Is there a cost to poor communication in cancer care?: a critical review of the literature. Psychooncology. 2005 Oct;14(10):875-84; discussion 885-6. doi: 10.1002/pon.947.
- Background: PubMed 30039853Moore PM, Rivera S, Bravo-Soto GA, Olivares C, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database Syst Rev. 2018 Jul 24;7(7):CD003751. doi: 10.1002/14651858.CD003751.pub4.
- Background: PubMed 23730434Anderson PA. Giving feedback on clinical skills: are we starving our young? J Grad Med Educ. 2012 Jun;4(2):154-8. doi: 10.4300/JGME-D-11-000295.1.
- Background: PubMed 33272265Burgess A, van Diggele C, Roberts C, Mellis C. Feedback in the clinical setting. BMC Med Educ. 2020 Dec 3;20(Suppl 2):460. doi: 10.1186/s12909-020-02280-5.
- Background: PubMed 11879860Fallowfield L, Jenkins V, Farewell V, Saul J, Duffy A, Eves R. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):650-6. doi: 10.1016/S0140-6736(02)07810-8.
- Background: PubMed 17337337Ammentorp J, Sabroe S, Kofoed PE, Mainz J. The effect of training in communication skills on medical doctors' and nurses' self-efficacy. A randomized controlled trial. Patient Educ Couns. 2007 Jun;66(3):270-7. doi: 10.1016/j.pec.2006.12.012. Epub 2007 Mar 2.
- Background: PubMed 14502593Finset A, Ekeberg O, Eide H, Aspegren K. Long term benefits of communication skills training for cancer doctors. Psychooncology. 2003 Oct-Nov;12(7):686-93. doi: 10.1002/pon.691.
- Background: PubMed 23414658Gulbrandsen P, Jensen BF, Finset A, Blanch-Hartigan D. Long-term effect of communication training on the relationship between physicians' self-efficacy and performance. Patient Educ Couns. 2013 May;91(2):180-5. doi: 10.1016/j.pec.2012.11.015. Epub 2013 Feb 12.
- 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.
Kerstin Kiis Antonsen, MD principal investigator
University Hospital of Southern Denmark - Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site supportive communication training in people with Communication Programs and Communication, Manual, run by Vejle Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 26 Jun 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in rate of "Excellent" scores on the Communication Assessment Tool between the intervention and the control group. (time frame: 6 months). 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 NCT05842083, which also lists 21 linked publications.
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 26 Jun 2024.