NCT05842083

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

April 24, 2023

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    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.

    6 months

  • Change in oncologists' rating of job satisfaction from before to after on-site communication training.

    6 months

Study Arms (2)

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.

Behavioral: On-site supportive communication training

Control

NO INTERVENTION

Oncologists in the control group will conduct consultations as usual.

Interventions

On-site supportive communication training

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, University Hospital of Southern Denmark - Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (21)

  • 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.

    PMID: 24519814BACKGROUND
  • 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.

    PMID: 11352412BACKGROUND
  • Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

    PMID: 7728691BACKGROUND
  • 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.

    PMID: 19796910BACKGROUND
  • 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.

    PMID: 16200515BACKGROUND
  • 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.

    PMID: 30039853BACKGROUND
  • 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.

    PMID: 23730434BACKGROUND
  • 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.

    PMID: 33272265BACKGROUND
  • 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.

    PMID: 11879860BACKGROUND
  • 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.

    PMID: 17337337BACKGROUND
  • 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.

    PMID: 14502593BACKGROUND
  • 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.

    PMID: 23414658BACKGROUND
  • 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.

    PMID: 20453053BACKGROUND
  • 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.

    PMID: 20082173BACKGROUND
  • Milne D. An empirical definition of clinical supervision. Br J Clin Psychol. 2007 Nov;46(Pt 4):437-47. doi: 10.1348/014466507X197415.

    PMID: 17535535BACKGROUND
  • Bernard JM, & Goodyear, R. K. Fundamentals of clinical supervision, 2004.

    BACKGROUND
  • 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.

    PMID: 31220279BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27756291BACKGROUND
  • Antonsen KK, Lyhne JD, Johnsen AT, Esser-Naumann S, Poulsen LO, Lund L, Timm S, Jensen LH. Assessing the effect of On-site supportive communication training (On-site SCT) on doctor burnout: a randomized controlled trial. BMC Med Educ. 2025 Jan 23;25(1):112. doi: 10.1186/s12909-025-06710-0.

  • Kk A, At J, Lo P, Jd L, L L, S EN, S T, Lh J. Effects of on-site Supportive Communication Training (On-site SCT) on doctor-patient communication in oncology: Study protocol of a randomized, controlled mixed-methods trial. BMC Med Educ. 2024 May 10;24(1):522. doi: 10.1186/s12909-024-05496-x.

MeSH Terms

Conditions

CommunicationManual CommunicationNeoplasmsOccupational StressBurnout, PsychologicalPatient Satisfaction

Condition Hierarchy (Ancestors)

BehaviorNonverbal CommunicationOccupational DiseasesStress, PsychologicalBehavioral SymptomsTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Kerstin Kiis Antonsen, MD

    University Hospital of Southern Denmark - Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Oncologists will be randomized between the intervention and usual practice.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations