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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05842083
Other study ID # On-site SCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date June 2024

Study information

Verified date May 2024
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Behavioral:
On-site supportive communication training
On-site supportive communication training

Locations

Country Name City State
Denmark Department of Oncology, University Hospital of Southern Denmark - Vejle Hospital Vejle

Sponsors (3)

Lead Sponsor Collaborator
Vejle Hospital Aalborg University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (19)

Ammentorp 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. — View Citation

Anderson 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. — View Citation

Axboe MK, Christensen KS, Kofoed PE, Ammentorp J. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC Med Educ. 2016 Oct 18;16(1):272. doi: 10.1186/s12909-016-0798-7. — View Citation

Bernard JM, & Goodyear, R. K. Fundamentals of clinical supervision, 2004.

Bragard 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. — View Citation

Bragard 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. — View Citation

Burgess 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. — View Citation

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. — View Citation

Fallowfield 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. — View Citation

Finset 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. — View Citation

Gattellari 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. — View Citation

Gulbrandsen 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. — View Citation

Iversen ED, Steinsbekk A, Falbe Vind B, Bangsgaard A, Cold S, Ammentorp J. Translation and cultural adaptation of the Communication Assessment Tool (CAT), developing a Danish and Norwegian version. Int J Qual Health Care. 2019 Dec 31;31(10):748-751. doi: 10.1093/intqhc/mzz020. — View Citation

Kristensen TS, Borritz M, Villadsen E, Christensen KB. The Copenhagen Burnout Inventory: A new tool for the assessment of burnout. Work & Stress. 2005;19(3):192-207.

Milne D. An empirical definition of clinical supervision. Br J Clin Psychol. 2007 Nov;46(Pt 4):437-47. doi: 10.1348/014466507X197415. — View Citation

Moore 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. — View Citation

Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33. — View Citation

Thorne 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. — View Citation

Vogel 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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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). 6 months
Secondary 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) 6 months
Secondary 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. 6 months
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