Trial of Two Different Information Materials in Patients With Advanced Cancer

Caregivers:

You do not have to agree to be in this study in order for the patient to take part.

If you agree to take part in this study, you will be randomly assigned (as in the roll of the
dice) to 1 of 2 groups to receive either the new informational material or the regular
informational material. This is done because no one knows if one study group is better, the
same, or worse than the other group.

Both you and the patient will receive the same sheet. It should take about 5 minutes to read
through either the new informational material or the regular informational material.

When you meet with the doctor, you will use either the new informational material or the
regular informational material and ask questions. You will choose topics from the sheet that
you would most like to discuss with the doctor. This conversation will be audio-recorded and
later transcribed (copied down) into a word-for-word script and kept by the study team for
research purposes. You may keep a copy of the new informational material or the regular
informational material for future use. Copies of the audio-recordings will be sent to you via
encrypted e-mail upon request.

You will then be asked you to complete a questionnaire about your opinions of the material
you read. This questionnaire should take about 5 minutes to complete.

Length of Study:

Your participation on this study will be over after you have completed the last
questionnaire. Your participation on this study should last about 10-15 minutes, depending on
how long it takes you to complete the questionnaires.

Other Information:

You will be asked not to discuss your answers with the patient.

Patients:

If you agree to take part in this study, you will be asked to complete a questionnaire about
any feelings of anxiety you have before talking with the doctor and then again afterwards.
This should take about 5 minutes to complete each time.

You will also be asked to complete 2 questionnaires about how much information you prefer to
receive about the disease and how you prefer to make decisions about the disease and
treatment. These questionnaires should take about 3 minutes to complete.

Study Groups:

After you have completed the first 3 questionnaires, you will be randomly assigned (as in the
roll of the dice) to 1 of 2 groups to receive either the new informational material or the
regular informational material. This is done because no one knows if one study group is
better, the same, or worse than the other group.

It should take about 5 minutes to read through the material you received.

When you meet with your doctor, you will use either the new informational material or the
regular informational material to ask questions. You will choose topics from the sheet that
you would most like to discuss with your doctor. This conversation will be audio-recorded and
later transcribed (copied down) into a word-for-word script and kept by the study team for
research purposes. You may keep a copy of the material you received for future use. Copies of
the audio-recordings will be sent to you via encrypted e-mail upon request.

After talking with the doctor, the research staff will ask you to complete 3 questionnaires
about your level of anxiety, your opinions of the reading material, and how satisfied you are
with the conversation you had with your doctor. These questionnaires should take about 15
minutes to complete.

Follow-Up Visit:

About 4 weeks (+/-14 days) later, you will return to the clinic for a routine follow-up
visit. You will be given both the new informational material and the regular informational
material. It should take about 10 minutes to read both.

You will then be asked to complete a questionnaire about how much you like or dislike the
material. It should take about 2 minutes to complete the questionnaire.

Length of Study:

Your participation on this study will be over after you have completed the last questionnaire
at your routine follow-up visit. Your participation in this study may last 3-5 weeks,
depending when your follow-up visit is scheduled.

Other Information:

If you have a caregiver present, he/she will also be asked to participate. You will be asked
not to discuss your answers with your caregiver.

Inclusion Criteria:

1. (Patient participation) Age 18 years or older

2. (Patient participation) First outpatient consultation visit with a palliative care
specialist.

3. (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

4. (Patient participation) Ability to read and communicate in English

5. (Patient participation) Diagnosis of advanced cancer

6. (Patient participation) Signed written informed consent form

7. (Caregiver participation) accompanied the patient to the clinic visit

8. (Caregiver participation) is identified by the patient as someone who is actively
involved in their overall care

9. (Caregiver participation) is able to read and communicate in English

10. (Caregiver participation) is willing to participate in the study and able to complete
the questionnaires

11. (Physician participation) a palliative medicine specialist

12. (Physician participation) seeing the patient in consultation on the day of the study

13. (Physician participation) willing to participate in the study

Exclusion Criteria:

1) Refusal to participate in the study