RCT of QPS vs General Information Sheet

PRIMARY OBJECTIVES:

I. To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).

SECONDARY OBJECTIVES:

I. To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.

II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.

III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.

IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.

V. To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.

VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.

VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.

VIII. To explore the factors underlying patients' preferences for the QPS or GIS.

OUTLINE: Participants are randomized into 1 of 2 groups.

GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

Inclusion criteria

• (Patient participation) First outpatient consultation visit with a palliative care specialist
• (Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
• (Patient participation) Ability to read and communicate in English
• (Patient participation) Diagnosis of advanced cancer
• (Patient participation) Signed written informed consent form
• (Caregiver participation) accompanied the patient to the clinic visit
• (Caregiver participation) is identified by the patient as someone who is actively involved in their overall care
• (Caregiver participation) is able to read and communicate in English
• (Caregiver participation) is willing to participate in the study and able to complete the questionnaires
• (Physician participation) a palliative medicine specialist
• (Physician participation) seeing the patient in consultation on the day of the study
• (Physician participation) willing to participate in the study

Exclusion criteria

• Refusal to participate in the study