Supporting Doctor-patient Communication in Oncology
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|ClinicalTrials.gov Identifier: NCT02278900|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : December 3, 2019
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
- Encouraging patients/caregivers to ask more questions, particularly about sensitive topics such as prognosis (as an effect of QPL alone)
- Increasing shared decision-making (as an effect of QPL alone)
- Improving overall satisfaction with the consultation and information retrieved (as an effect of both communication aids)
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
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
- 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.
- 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
- 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"
- 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
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
|University hospital of North Norway|
|Principal Investigator:||Tone Nordøy||UNN|