Supporting Doctor-patient Communication in Oncology

NCT02278900 | Terminated

• 1 other identifier: 2014/1759(REK)
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Communication

Keywords

communication; shared decision-making

Outcome Measures

Primary Outcomes (1)

• Difference in number of questions asked, and especially concerning prognosis.

  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.

  At day of first consultation

Secondary Outcomes (1)

• Difference in shared decision making

  At day of first consultation

Other Outcomes (2)

• Difference HADS score Difference in satisfaction with the consultation and information retrieved.

  One week after the first consultation and two months after first consultation

• Difference in health related quality of life

  One week after the first consultation and two months after first consultation

Study Arms (2)

Communication aids

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention.

Interventions

Communication aids OTHER

Question Prompt list Audiofile

Communication aids

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University hospital of North Norway

Tromsø, Norway

Location

MeSH Terms

Conditions

Communication

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Tone Nordøy

  UNN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: October 30, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: December 2, 2019
• Last Updated: March 6, 2024

Record last verified: 2015-12

Locations

NO (1)