Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supporting Doctor-patient Communication in Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278900
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:

Aims of study While various communication aids have been evaluated separately, no studies have taken a coordinated approach combining aids with different goals to evaluate their combined impact. In this study the investigators will use two communication aids; a QPL and an audio recording of the consultation. QPLs includes question concerning treatment options, but few studies involving QPLs have explored whether QPLs result in patients taking a more active role in the consultation. To our knowledge there have not been studies which objectively try to explore whether patients receiving QPLs participates in shared decision making to a greater extent, except for one ongoing Italian trial of breast cancer patients.

To explore and describe how communication aids as a QPL and an audio recording of the consultation improve the first doctor-patient consultation at the oncology outpatient clinic by

  1. Encouraging patients/caregivers to ask more questions, particularly about sensitive topics such as prognosis (as an effect of QPL alone)
  2. Increasing shared decision-making (as an effect of QPL alone)
  3. Improving overall satisfaction with the consultation and information retrieved (as an effect of both communication aids)
  4. Affecting quality of life/anxiety/depression (as an effect of both communication aids)

Condition or disease Intervention/treatment Phase
Communication Other: Communication aids Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Supporting Doctor-patient Communication in Oncology. A Randomized Controlled Trial (RCT) of Question Prompt List and Audio Recording as Communication Aids in Oncology Consultation
Study Start Date : April 2014
Actual Primary Completion Date : November 2019
Actual Study Completion Date : December 2, 2019

Arm Intervention/treatment
Experimental: Communication aids
Patients in the intervention group will receive the QPL at home in advance of the consultation along with information about the clinic.The consultations will be recorded in both the control and intervention group. The recording will be done on the computer, and the patients in the intervention group will be given the recording immediately after the consultation on a memory stick.
Other: Communication aids
Question Prompt list Audiofile

No Intervention: Control group
No intervention.



Primary Outcome Measures :
  1. Difference in number of questions asked, and especially concerning prognosis. [ Time Frame: At day of first consultation ]
    Analysis of the audio recorded consultations Collaborators of the investigators in Sydney have developed a manual and coding sheet to enable standardization of the coding procedure for the consultations with "Question prompt lists". This will be translated to Norwegian. The audio recordings will be transcribed and patients questions and concerns will be counted and categorized according to topics covered by the QPL. Physician endorsement of the QPL will be coded as either absent, basic or extended.


Secondary Outcome Measures :
  1. Difference in shared decision making [ Time Frame: At day of first consultation ]
    The coders will be trained to use the "Option scale" to score patient involvement in decision making. The option scale consists of 12 dimensions of a collaborative decision making process and the dimensions will be registered by frequency


Other Outcome Measures:
  1. Difference HADS score Difference in satisfaction with the consultation and information retrieved. [ Time Frame: One week after the first consultation and two months after first consultation ]
    Hospital anxiety and depression scale (HADS) EORTC QLQ-C30 Questions concerning the patients experience with this communication aid. Questions from "Survey on Norwegian cancer patients' experience of hospital"

  2. Difference in health related quality of life [ Time Frame: One week after the first consultation and two months after first consultation ]
    Health related quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Norwegian speaking cancer patients at their first consultation at the outpatient clinic with newly diagnosed cancer or relapse of cancer.
  • Age 18 and above who has given written informed consent to participate in the study.

Exclusion Criteria:

  • Mental impairment which will make informed consent difficult to retrieve.
  • Not having access to computer/device to listen to audio file.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278900


Locations
Layout table for location information
Norway
University hospital of North Norway
Tromso, Norway
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Layout table for investigator information
Principal Investigator: Tone Nordøy UNN

Layout table for additonal information
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02278900    
Other Study ID Numbers: 2014/1759(REK)
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2015
Keywords provided by University Hospital of North Norway:
communication
shared decision-making
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms