Interview Guide

INTERVIEW GUIDE

Patient Interviews for Breast Cancer

Study Objectives / Progression of Questions in Interview Guide
Primary Objective of Study: To understand and document the patient’s experience of breast cancer by exploring concepts that are relevant and important to the measurement of breast cancer symptoms, treatment side effects and life impacts from the patient perspective.
The primary purpose of each interview is to identify and describe symptoms and signs of Breast cancer that patients experience, and to identify and describe the impacts of Breast Cancer and treatment side effects on patients’ lives.
At the end of these interviews, there will be a sufficiently thorough exploration of all concepts in order to provide:
  • documentation that will support the relevance and importance of each concept
  • identification of the best patient language to use in measuring each concept
  • evidence of the relative predominance of the concept that would support its use or exclusion in the development of a conceptual model.
/ MAIN QUESTIONS:
  1. History of experience with breast cancer
  2. Symptoms or sensations attributed to the cancer
  3. Discussion to ensure all relevant breast cancer symptoms are mentioned
  4. Questions to characterize each symptom
  5. Probing specific breast cancer symptoms that may not have already been mentioned
  6. Questions about patient’s ability to distinguish the signs/symptoms of cancer or attribute to treatment or side effect of treatment
  7. Identification of breast cancer impacts
  8. Questions to characterize each impact
  9. Exploration of most bothersome impact
  10. Questions about treatment side effects
  11. Explore patient’s response about impacts of treatment/side effects related to treatment
  12. How much of an improvement to current treatment would patient define as successful
Note to Interviewer: If patients appear to be getting tired or struggling with the interview then sections 10-12 can be skipped if necessary.

If an adverse event is raised during the interview

If an Adverse Event is raised during the interview wait until the end of the interview to collect the details from the respondent. Suggested text to read out is provided at the end of this discussion guide. Ensure that you check what contact details the respondent is willing to pass on to the Drug Safety Department.

Remember, an Adverse Event must be reported when the following are present:

PREP – Patient, Reporter, Event, Product

  1. A Patient or group of patients
  • Identifiers such as age, age group, birth date, gender, role, profession should be collected if available, if not the event should still be reported.
  1. An identifiable Reporting source
  • Information that identifies the reporter, establishing knowledge of the reportable event in an identifiable consumer.
  • The reporter could be a patient, doctor, patient’s parent, friend, colleague or carer.
  1. An adverse Event
  • Description of at least one event or product complaint.
  1. A suspect Product
  • Patient must mention taking one of the products being marketed by the company that we are doing research for

Remember: The event need not have a causal relationship with the treatment or usage.

An adverse event is:

“Any untoward medical occurrence in a patient administered an Astra Zeneca medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (e.g an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.”

An adverse event can also be revealed through follow up on a product complaint (PC).For these purposes a PC is a complaint specific to the product itself, or packaging, as opposed to its effect on the patient. Examples include damaged or missing tablets; wrong strength or color of tablets; damaged packaging; a label that cannot be read; a liquid that should be clear but is cloudy or contains unexpected particles; a bent needle, a broken syringe; a missing patient information leaflet or the identification of a potentially counterfeit medicine.

Cases where a woman is pregnant or breastfeeding whilst taking a company’s medicine also need to be collected even if no AE is specifically cited. In these instances, it is important to capture whether or not there were any complications during the pregnancy or any congenital abnormalities occurring in the baby.

If the respondent mentions an adverse event experienced while taking an Astra Zeneca product, or a product you suspect is an Astra Zeneca product, you should make a note of it and at the end of the interview go through the ‘Adverse Event/Product Complaint Form’. At this time please state the following to the patient:

“During the interview you mentioned a problem that you experienced while taking [product name]. The sponsor of this research needs to collect information about their products in order to continue making them as safe and effective as possible. Every report they receive contains potentially useful information. I would like to spend a couple of minutes with you now to collect some more details. Is that OK with you?”

If yes“Thank you. The information you provide will be sent to the study sponsor, who may wish to contact your doctor for further information. If you agree to provide your doctor’s name, this will not be linked in any way to your other responses given during the interview. Are you happy to provide the name of your doctor?”

(If the respondent subsequently says no, then go to the ‘If no’ section)

If no“OK that’s fine. However, as the information you were given about this study explained, we do have to report this problem to the sponsor. This will be done anonymously, and none of your personal details will be shared with them.”

You should complete the ‘Adverse Event/Product Complaint Form’ with as much detail as you can retrieve.

All Adverse event form should be completed and forwarded to or faxed to +1 302 886 2623 within 24 hours of you becoming aware of the event.

CONCEPT ELICITATION INTERVIEW GUIDE

Patient Interviews for Breast Cancer

TO BEGIN:

  1. Introduce yourself and your association with the study
  2. Explain purpose of the interview
  3. Thank him/her for willingness to participate
  4. Assure him/her of confidentiality
  5. Let him/her know the general process of how it will proceed

The Primary Objective of this Interview:

This interview will take approximately 60 minutes. I will be asking you a variety of questions that will help us to better understand your experience with Breast Cancer, including the symptoms you may have and any impacts that this condition has had on your daily life. We will be asking about:

  • The overall history of your breast cancer
  • The symptoms you have because of breast cancer
  • The ways you feel that breast cancer affects you in day-to-day life, if at all
  • The areas of your life that are the most affected by breast cancer, if any
  • The treatment side effects you have experienced with your cancer treatment

HowThis InterviewWill Work:

I will be asking general questions, and after each one there will be some time for you to respond. We are interested in what you have to say about your experiences and preferences, so please respond with whatever is on your mind.

To begin the interview, I want to remind you that it is being recorded. I will not use your name from the point that I turn the recorder on, and I ask you to try and not use your name or the names of friends or family in any of your responses. This will help keep the interview anonymous.

I will only be using the recording to remind me of the important things you said so we can represent everything more accurately at the end of the study. A written version of the interview will be created using the recording, and that written version will then be put together with other interviews from everyone else taking part in these interviews. You won’t be able to be individually identified in any of the reports that result from these interviews. This study information will be used to help make better decisions about how to measure these important issues in future studies to develop new medicines.

Do you have any questions before we start?

CONCEPT ELICITATION INTERVIEW ITEMS

SECTION 1:

(Purpose: To settle the subject and locate them in the desired territory)

Before we start, I want to just check with you about how familiar you are with some words that we will be using throughout the interview.

I’m going to be using the term “Symptom” a lot in the first few questions so I’d like to know what the term “symptom” means to you. How would you describe in your own words what a “symptom” is?

[Interviewer]: Wait forpatient response, if patient does not understand symptom, use the following:

When I use the term “symptom” in the interview questions, I will be referring to a physical sensation or physical problem.

  1. When you talk to your family or your friends about what is happening with your health, how do you refer to your condition? What do you call it?
  • Enter description ______
  • About how long ago you were diagnosed with breast cancer?
  • [Interviewer: Enter # days ______and/or #months: ______]
  • Tell me about the symptoms you were experiencing when you were first diagnosed?
  • Tell me about the symptoms you have experienced recently?
  • Of all the symptoms you experienced at diagnosis, which symptom related to the breast cancer bothered you the most? Why?
  • Of all the symptoms you have experienced recently, which symptom related to the breast cancer bothers you the most? Why?

[INTERVIEWER: EXPLORE FULLY WITH THE PATIENT ALL SYMPTOMS MENTIONED, USING THE QUESTIONS AND PROBES PROVIDED IN SECTION 4.]

  • Have your symptoms changed in any way over the course of your breast cancer?

IF YES

  • Tell me about how they have changed


SECTION 2:

(Purpose: to focus patient on symptoms they attribute to their cancer)

  1. Can you think about a typical day in the past week, and describe the symptoms or physical sensations you experienced that you feel are related specifically to the breast cancer?
  • Are there specific symptoms you experience in the morning when you first get up?
  • What about as you get ready to go through your day?
  • What symptoms do you recognize having during the course of the day?
  • How about during the early evening time or the night?

[Interviewer]: As the patient offers each new symptom, write it on the Symptom worksheet for your own reference. Then explore fully using the probes in section 4.

SECTION 3:

(Purpose: To make sure all the symptoms the patient experiences have come out for discussion)

So far, you have spoken about the following symptoms:

[Interviewer: list them for patient]

  1. How about any other symptoms that you have had, but not very frequently?

[Interviewer]: Add any new symptoms patient has yet to offer spontaneously

SECTION 4:

(Purpose: To explore the characteristics of all symptoms that the patient experiences)

Next I’m going to ask you some very specific questions about each of the symptoms you have talked about having. [Interviewer]: Note symptoms offered spontaneously by patient (using their own language) on the symptom worksheet and be sure to explore each one fully using the probes below.

A: Shortness of breathspontaneously offered probed response

Mark each  when asked, strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what shortness of breath feels like to somebody who hasn’t experienced it?

 Do you think this is a result of you breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 How often do you experience shortness of breath now?  How long does shortness of breath usually last when it happens?

 Is shortness of breath worse at a particular time of day, such as in the morning, afternoon, evening or overnight? Note to interviewer: Only ask this question if not already discussed in section 2.

 How much does shortness of breath vary each time you have it? Has your experience changed at all over the last few months?

 When you have shortness of breath how bad (severe) is it generally?

(On a scale of 0 =none to 10=extremely severe)

 Is there anything in particular that causes shortness of breath to occur? Is there anything that makes it worse?

 How does shortness of breath cause difficulty for you in general?

 What bothers you the most about shortness of breath?

B: Swollen armsspontaneously offered probed response

Mark each  when asked Strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what your swollen arms feel like to somebody who hasn’t experienced it?

 Do you think this is a result of your breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 How often do you get swollen arms now?

 How long does it usually last when it happens?

 Is the swelling in your arms worse at a particular time of day, such as in the morning, afternoon, evening or overnight?

 How much does the swelling in your arms vary each time you have it? Has your experience changed at all over the last few months?

 When you have swollen arms, how bad (severe) is it generally?

(On a scale of 0 =none to 10=extremely severe)

 Is there anything in particular that causes the swelling in your arms to occur? Is there anything that makes it worse?

 How does the swelling in your arms cause difficulty for you in general?

 What bothers you the most about having swollen arms?

C: Hair Lossspontaneously offered probed response

Mark each  when asked Strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what it feels like to lose your hair to somebody who hasn’t experienced it?

 Do you think this is a result of your breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 How bad (severe) would you say your hair loss is?

(On a scale of 0 =none to 10=extremely severe)

 How much has losing your hair affected your quality of life?

 What bothers you the most about your hair loss?

D: Change in weightspontaneously offered probed response

Mark each  when asked Strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what the changes in your weight feels like to somebody who hasn’t experienced it?

 Do you think this is a result of your breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 Has your weight varied at all over the last few months?

 How bad (severe) would you say your weight loss/gain is on a 0-10 scale?

(On a scale of 0 =none to 10=extremely severe)

 Is there anything in particular that you think caused the change in your weight to occur?

 How does this weight loss/gain cause difficulty for you in general?

 What bothers you the most about your weight loss/gain?

E: Painspontaneously offered probed response

Mark each  when asked Strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what the pain you have experienced feels like to somebody who hasn’t experienced it?

 Do you think the pain you experience is a result of your breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 How often do you experience pain now?

 How long does it usually last?

 Is the pain worse at a particular time of day, such as in the morning, afternoon, evening or overnight?

 How much does the pain vary each time you have it? Has your experience changed at all over the last few months?

 When you experience pain, how bad (severe) is it generally?

(On a scale of 0 =none to 10=extremely severe)

 Is there anything in particular that causes the pain to occur? Is there anything that makes it worse?

 How does the pain cause difficulty for you in general?

 What bothers you the most about the pain?

F: Moving around/mobilityspontaneously offered probed response

Mark each  when asked Strike through the box  if there was a reason to not ask the probe for this symptom

 How would you describe what your difficulty moving around feels like to somebody who doesn’t have it?

 Do you think this is a result of your breast cancer, or a result of your cancer treatment? What makes you feel that this is related to the breast cancer/cancer treatment?

 How often do you have difficulty moving around now?

 How long does it usually last when it happens?

 Is this difficulty moving around worse at a particular time of day, such as in the morning, afternoon, evening or overnight?