Supplemental Files
Supplementary Table S1. Hypothetical Patient Profiles
Profile / DescriptionPatient profile 1 / A 57-year-old woman was diagnosed with breast cancer and developed bone metastases along with 2-cm mediastinal and supraclavicular adenopathy 3 years after her initial diagnosis. She initially received TC adjuvant chemotherapy. The tumor was ER/PR positive and HER2 negative. She was on an adjuvant aromatase inhibitor at the time of her relapse. Her recurrence was noted by examination identifying the supraclavicular adenopathy. On further questioning she admits to increasing mid back (thoracic area) pain, which she rates as a 4 on a scale of 0–10. The patient’s health is otherwise good (high performance status) with no history of kidney disease and no significant comorbidities.
Patient profile 2 / A 71-year-old man was initially diagnosed with Gleason 810 prostate cancer 3 years ago. He is now castration resistant and has developed bone metastases. His PSA level is ≥10. He is complaining of left hip pain when he walks and low back pain if he sits too long, which he rates as a 4 on a scale from 0–10. The patient’s health is otherwise good (high performance status) with no history of kidney disease and no significant comorbidities.
ER/PR=estrogen receptor/progesterone receptor; HER2=human epidermal growth factor receptor 2; PSA=prostate-specific antigen; TC=docetaxel/cyclophosphamide.
Supplementary Table S2. Characteristics of Respondents: Patients and Caregiversa
Category / Patients(n=187) / Caregivers
(n=197)
Mean (SD) age, y / 42.9 (16.9)b / 35.6 (12.9)
Male sex / 58.1c / 60.7d
Type of cancer leading to bone metastases
Breast / 34.2 / 29.6d
Prostate / 19.8 / 17.3d
Lung / 12.3 / 13.8d
Kidney / 10.2 / 11.7d
Thyroid / 5.3 / 9.2d
Melanoma / 4.8 / 9.7d
Other / 13.4 / 8.7d
Employed / 44.1c / 67.0
Less than 1 year since diagnosed with bone metastases / 45.2c / 53.9e
Currently taking treatment to delay complications of bone metastases / 74.9 / 81.4f
Currently receiving chemotherapy / 69.5 / 73.8e
Losing ability to move around affected the patient the most in the past 2 weeks / 43.9 / 40.6g
Had a complication because of bone metastases / 73.4h / 74.2f
Rating of worst pain in the past week for any reason (0–10 scale), mean (SD) / 6.2 (2.7)i / 6.8 (2.0)h
aAll data are percentages unless otherwise specified.
bn=185.
cn=186.
dn=196.
en=195.
fn=194.
gn=192.
hn=184.
in=174.
Supplementary Table S3. Characteristics of Respondents: Nurses
Category / Nurses, %(N=196)
Age group, y
18–45 / 44.6
≥46 / 55.4
Which of the following best describes you?
Registered nurse / 79.6
Nurse practitioner / 15.3
Licensed practical nurse / 5.1
How many years have you practiced?
1–9 / 19.9
10–20 / 43.9
≥21 / 36.2
Which of the following describes your primary employment setting (select all that apply)?
Hospital staff / 54.6
Physician office/ambulatory care / 44.4
Other / 13.3
What is your primary nursing specialty?
Oncology / 75.5
Medical/surgical / 8.2
Other / 16.3
On average, how many patients with bone metastases from solid tumors do you treat each week?
≤10 / 52.6
>10 / 47.4
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Supplementary Table S4.Attribute Importance by Sample Based on the Attribute Levels Considered in the Studya
Patients / Caregivers / NursesAttribute / Mean Importance / Error / Rescaled Mean / Rescaled 95% CI / Mean Importance / Error / Rescaled Mean / Rescaled 95% CI / Mean Importance / Error / Rescaled Mean / Rescaled 95% CI
Time until first SRE / 0.37 / 0.17 / 2.65 / 1.47–3.82 / 0.37 / 0.17 / 4.86 / 2.69–7.02 / 1.60 / 0.51 / 4.68 / 3.20–6.16
Time until a 2-point increase in pain on the BPI / 0.24 / 0.15 / 1.69 / 0.59–2.79 / 0.24 / 0.15 / 3.10 / 1.08–5.12 / 1.25 / 0.43 / 3.65 / 2.38–4.92
Risk of ONJ each year / 0.16 / 0.15 / 1.16 / 0.09–2.23 / 0.16 / 0.15 / 2.13 / 0.17–4.09 / 0.58 / 0.33 / 1.70 / 0.74–2.66
Risk of 0.5-mg/dL increase in baseline creatinine each year / 0.85 / 0.23 / 6.01 / 4.35–7.66 / 1.06 / 0.23 / 13.87 / 10.91–16.82 / 2.12 / 0.57 / 6.20 / 4.52–7.88
Mode of administration / 0.16 / 0.15 / 1.13 / 0.09–2.17 / 0.16 / 0.15 / 2.08 / 0.17–3.99 / 1.14 / 0.41 / 3.32 / 2.11–4.53
Out-of-pocket cost to the patient each month / 1.41 / 0.20 / 10.00 / 8.57–11.43 / 0.77 / 0.20 / 10.00 / 7.37–12.63 / 3.42 / 0.85 / 10.00 / 7.50–12.50
BPI=Brief Pain Inventory; ONJ=osteonecrosis of the jaw; SRE=skeletal-related event.
aThe numbers in the ranking table had to be rescaled to reflect the importance of each attribute relative to the overall importance of out-of-pocket cost (where importance of increasing treatment from $25 to $330 is set to be 10). Without this rescaling, the ranking numbers cannot be compared across populations.
Supplementary Table S5.Mean Preference Estimates for the Treatment Groups
Patients / Caregivers / NursesAttribute / Attribute Level / Estimate / SE / Estimate / SE / Estimate / SE
Time until first SRE / 28 months / 0.174 / 0.045 / 0.174 / 0.045 / 0.889 / 0.139
18 months / 0.026 / 0.040 / 0.026 / 0.040 / -0.177 / 0.084
10 months / -0.199 / 0.049 / -0.199 / 0.049 / -0.712 / 0.133
Time until a 2-point increase in pain on the BPI / 10 months / 0.107 / 0.044 / 0.107 / 0.044 / 0.570 / 0.114
6 months / 0.023 / 0.043 / 0.023 / 0.043 / 0.108 / 0.088
3 months / -0.131 / 0.046 / -0.131 / 0.046 / -0.678 / 0.124
Risk of ONJ each year / None / 0.111 / 0.044 / 0.111 / 0.044 / 0.194 / 0.099
1 out of 100 (1%) / -0.059 / 0.042 / -0.059 / 0.042 / 0.195 / 0.085
5 out of 100 (5%) / -0.052 / 0.043 / -0.052 / 0.043 / -0.389 / 0.089
Risk of 0.5-mg/dL increase in baseline creatinine each year / None / 0.485 / 0.058 / 0.485 / 0.058 / 0.939 / 0.145
4 out of 100 (4%) / -0.124 / 0.064 / 0.094 / 0.054 / 0.242 / 0.100
10 out of 100 (10%) / -0.361 / 0.076 / -0.579 / 0.069 / -1.182 / 0.164
Mode of administration / Injection every 4 weeks / 0.095 / 0.043 / 0.095 / 0.043 / 0.474 / 0.107
15-minute infusion every 4 weeks / -0.031 / 0.041 / -0.031 / 0.041 / 0.189 / 0.098
120-minute every 4 weeks / -0.064 / 0.042 / -0.064 / 0.042 / -0.663 / 0.126
Out-of-pocket cost to the patient each month / $25 / 0.562 / 0.084 / 0.304 / 0.078 / 1.581 / 0.220
$75 / 0.331 / 0.049 / 0.179 / 0.046 / 0.549 / 0.122
$150 / -0.015 / 0.002 / -0.010 / 0.003 / -0.290 / 0.111
$330 / -0.847 / 0.126 / -0.463 / 0.119 / -1.841 / 0.239
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Supplementary Fig. S1Recruitment and disposition of respondents
Supplementary Appendix
Patient, Caregiver, and Nurse Preferences for Treatments for Bone Metastases from Solid Tumors
Yi Qian, PhD, Jorge Arellano, MSc, MPhil, A. Brett Hauber, PhD, Ateesha F. Mohamed, MA, Juan Marcos Gonzalez, PhD, Guy Hechmati, MD, MSc, Francesca Gatta, MSc, Stacey Harrelson, RN, CCRC, Cynthia Campbell-Baird, RN, OCN
Table of Contents
Survey Development Process
Patient Survey
Caregiver Survey
Nurses Survey
Survey Development Process
Pretest interviews were conducted with oncology patients, caregivers of oncology patients, and health care providers in the United States as part of a study of preferences for treatments for bone metastases from solid tumors. The purpose of the pretest interviews was to evaluate and improve the clarity and focus of the draft survey that was later be hosted and implemented as a Web survey.
Patients:Fifteen in-person, Webcam, and telephone pretest interviews were conducted in October 2012 in Philadelphia, Pennsylvania and Raleigh, North Carolina. Respondents were invited to participate in the pretest interviews if they had a self-reported physician diagnosis of bone metastases from solid tumors.
Caregivers:Three in-person and eight telephone pretest interviews were conducted in October 2012 in Philadelphia, Pennsylvania and Raleigh, North Carolina. Respondents were invited to participate in the pretest interviews if they were taking care of an individual with bone metastases from solid tumors.
Nurses: Two in-person and four telephone pretest interviews with nurses were conducted in October 2012 in Philadelphia, Pennsylvania and Raleigh, North Carolina. Respondents were invited to participate in the pretest interviews if they treated cancer patients with bone metastases from solid tumors.
Demographic Characteristics of Pretest Respondents
Although we attempted to recruit caregivers with diverse backgrounds and experiences, the pretest was based on a small convenience sample.
Comprehension of Risk Grids
Before answering the choice questions in the survey, respondents were presented with an explanation of the grids used to represent the risk of adverse events. Respondents clearly understood the risk grids and distinguished among the different levels of risk in the choice questions. All respondents were asked two risk-comprehension questions to test their understanding of the grids used to communicate the chance of adverse events. All health care providers and caregivers answered the risk-comprehension questions correctly. Only 1 patient answered the risk-comprehension questions incorrectly.
Choice Questions
Respondents had no difficulty making tradeoffs among the study attributes when answering the choice questions. In general, time until first skeletal-related event was the most important attribute to respondents. Respondents were willing to accept some risk of adverse events for better efficacy, and were sensitive to changes in treatment cost to the patient.
Patient Survey
Delaying Complications of Bone Metastases from Solid Tumors
Thank you for your interest in this health survey. In this survey, we will ask you about your experience with bone metastases and your preferences for different possible medicines to delay complications of bone metastases.
If you have any problems or concerns about this survey, please e-mail Ateesha Mohamed at .
Please answer the following questions to confirm that you are eligible to participate in this survey.
[Screening Questions]
S1.Are you 18 years of age or older?
YES [CONTINUE]
NO [INELIGIBLE, END SURVEY]
S2.Have you been told by a doctor that you have bone metastases from a solid tumor?
YES [CONTINUE]
NO [INELIGIBLE, END SURVEY]
Eligible if answer yes to S1 and S2.
Ineligible, end survey.
[Consent Screen 1]
Study Purpose
You are one of about 700 people with bone metastases in the United States, the United Kingdom, France, and Germany who are being asked to take a survey to help us understand people’s preferences for different medicines to delay complications of bone metastases. In this survey we will ask you about your experience with bone metastases and your thoughts about possible medicines to delay complications of bone metastases.
Study Duration
The survey will take about 25 minutes to complete.
Study Details
This research study is being run by Research Triangle Institute (RTI) on behalf of a pharmaceutical company. RTI is a not-for-profit research organization in Research Triangle Park, North Carolina, United States. RTI has contracted with Harris Interactive to collect data. If you have questions about this survey, please send an e-mail to RTI investigators at . Messages will be answered within 24 hours of their receipt.
[Consent Screen 2]
Possible Risks or Discomforts
If any questions make you uncomfortable, you do not need to answer them.
Harris Interactive will protect your responses under its Privacy Policy. RTI and the pharmaceutical company will receive your survey responses, no personal identifiers. RTI also will make every effort to protect your responses. There is a potential risk of disclosure of the survey data, but the data could not be directly tied to you.
If you have concerns about your rights as a participant, you may e-mail the RTI Office of Research Protection at .
Benefits
There are no direct health benefits to you or the person you are caring for with bone metastases from participating in this study. Your responses are very important because they will help researchers to understand people’s preferences for different medicines to delay complications of bone metastases.
[Consent Screen 3]
Confidentiality
Many steps have been taken to protect your information. Harris Interactive will report only your responses to RTI, not your names. If the results of this study are presented at scientific meetings or published in scientific journals, no information will be included that could identify you or your responses personally.
The Institutional Review Board (IRB) at RTI has reviewed this research. An IRB is a group of people who make sure that the rights of participants in research are protected. The IRB may check records of your activity in this research to see if proper procedures were followed.
Your Rights
Your decision to take part in this research study is completely voluntary. Your decision to participate in this study will not affect your usual medical care. You can refuse to answer any question or stop at any point after you begin the survey and still receive your Harris Interactive points for participating in the survey.
[Consent Screen 4]
If you have read the previous screens and agree to participate, please click the Yes button, if not, click the No button.
Yes, Iagree to participate. [continue with next section]
No, I do not agree to participate. [go on to next question]
Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue this survey; if not, select the No button to exit.
Yes, Iagree to participate. [continue with next section]
No, I do not agree to participate [end survey].
[If they do not agree to participate]
Thank you for your time. You have exited the survey.
Please tell us about yourself
B1.B1.What is your gender?
Male
Female
B2.B2.What year were you born? ______
B3.Programmer note: Please include a drop-down menu from 1922 to 1994.
B4.B3.What is your marital status?
Married
Widowed
Divorced or separated
Single
Other
B6.
B7.B4. What is the highest level of education you have completed?
(Check only one answer.)
Less than high school
Some high school
High school or equivalent (e.g., GED)
Some college but no degree
Technical school
Associate’s degree (2-year college degree)
4-year college degree (e.g., BA, BS)
Some graduate school but no degree
Graduate or professional degree (e.g., MBA, MS, MD, PhD)
B5. Which of the following best describes your employment status?
(Check only one answer.)
Employed
Self-employed
Student
Retired
Disabled and unable to work
Unemployed
Questions about Your Experience with Bone Metastases
You have been invited to take part in this survey because you have indicated that you have been diagnosed with cancerthat has spread to your bones. The cancer that now is in your bones is called bone metastases. Bone metastases can cause complications such as a bone fracture.
We would like to ask you some questions related to your bone metastases.
- Which type of cancer led to your bone metastases?
Breast cancer
Prostate cancer
Lung cancer
Kidney cancer
Thyroid cancer
Melanoma
Other
- How long ago did a doctor tell you that you had this type of cancer?
(Check only one answer.)
Less than six months ago
At least six months ago, but less than one year ago
At least one year ago, but less than two years ago
At least two years ago, but less than five years ago
At least five years ago
- To which bone(s) has your cancer spread?
(Check all that apply.)
Arms, legs
Spine or neck
Hips, shoulders, collar bone
Skull
Ribs, sternum
- How long ago did a doctor tell you that you had bone metastases?
(Check only one answer.)
Less than six months ago
At least six months ago, but less than one year ago
At least one year ago, but less than two years ago
At least two years ago, but less than five years ago
At least five years ago
- Are you currently taking any treatment specifically to delay complications of bone metastases such as a bone fracture?
Yes [Skip to Question 7]
No [Go to next question]
Don’t know [Go to next question]
- Have you ever taken any treatment specifically to delay complications of bone metastases such as a bone fracture?
Yes [Go to next question]
No [Go to Question 8]
Don’t know [Go to Question 8]
- How do you (or did you) receive your treatment to delay complications of bone metastases such as a bone fracture?
Pills or tablets
Intravenous (IV) medicine (at a doctor’s office, hospital, or clinic)
Shots or injections (at a doctor’s office, hospital, or clinic)
Don’t know
- Are you currently receiving any chemotherapy?
Yes [Go to next question]
No [Go to question 12]
- How do you receive your chemotherapy?
Pills or tablets
Intravenous (IV) medicine (at a doctor’s office, hospital, or clinic)
Directly to the abdomen
- [If Question 9 = IV] How long do you usually spend in the infusion room receiving your chemotherapy?
___ hour(s) and ___ minute(s)
- [If Question 9 = “Intravenous (IV) medicine”] Do you have a port to receive your chemotherapy?
Yes
No
- Bone metastases can affect your ability to do usual daily activities. Which of the following changes in usual daily activities has affected you the most in the past 2 weeks? (Check only one answer.)
Losing your ability to move around as you used to
Losing your independence
Having to limit your social life
I have not experienced any changes affecting my usual daily activities
Other
Features of Medicines to Delay Complications of Bone Metastases
Bone metastases can cause complications such as a bone fracture. In this section, we will describe the features of different medicines that could be used to delay complications of bone metastases. Your doctor may prescribe these medicines in addition to your regular chemotherapy.
The features of these medicines include:
- Months until you haveacomplication of bone metastases
- Months until your pain gets worse
- Chance of a problem with your teeth and/or jaw bone each year because of the medicine
- Chance of kidney damage each year because of the medicine
- How you take the medicine
- Personal cost to you per month
In the next few pages, we will describe each of these treatment features. If you need to, you can refer to this information as you take the survey.
Medicine Feature: Months until you have a complication of bone metastases
If you have bone metastases, you probably will have a complication such as a bone fracture at some point in the future. A complication of bone metastases could be:
- A fracture or broken bone
- Radiation therapy to prevent a fracture and/or to treat bone pain,
- Surgery to the bone to prevent a fracture
- Increased pressure on the spinal cord
If you have radiation therapy, you may feel tired and your skin may burn like sunburn.
If you have pressure on the spinal cord, you may have weakness or tingling in your legs, and loss of bladder or bowel control.
Whether or not you have pain, you are at risk for these complications if you have bone metastases
Medicines can help delay these types of complications. The number of months until you have a complication because of bone metastases is a way to measure how well the medicine is working. If the medicine is working, the time until you have a complication will be longer.
- Have you ever had a complication because of bone metastases?
Yes
No
Don’t know
- Which of the following complications of bone metastases worries you the most?
(Check only one answer.)
A bone fracture
Radiation therapy to prevent a fracture and/or to treat bone pain
Surgery to the bone to prevent a fracture
Increased pressure on the spinal cord
Medicine Feature: Months until your pain gets worse
When you have bone metastases you may experience pain that can keep you from doing your usual daily activities such as walking, doing normal activities outside the home, or doing housework. If you have bone metastases, the pain probably will get worse at some point in the future.
Medicines can help delay the time until your pain gets worse. The number of months until your pain gets worse is a way to measure how well the medicine is working. If the medicine is working, the time until your pain gets worse will be longer.
People often are asked to rate their pain using a 0 to 10 scale. The scale goes from no pain (0) to the worst pain they can imagine (10).