Background
Methods
Development history of measures
The National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b
Patient recruitment
Inclusion criteria: • Subject had to sign and date a written Informed Consent Form (ICF); • Subject was an adult man or woman (≥18 years of age) at the time of screening; • Subject had clinician confirmation of metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy; • Subject had clinician confirmation of hormone-receptor positive (HR+; estrogen receptor positive and/or progesterone receptor positive) and human epidermal growth factor receptor-2 negative (HER2-) breast cancer; • Subject was able to speak, read, write, and comprehend US English fluently, as determined by clinician; and • Subject was willing and able to participate in a 90-min, face-to-face or telephone interview. Exclusion criteria: • Subject had received more than three lines of therapy for advanced breast cancer; • Subject had central nervous system involvement such as brain metastases or spinal cord compression; • Subject had participated in an interventional clinical trial in the past 30 days; or • Subject had any other concurrent severe and/or uncontrolled medical condition including a cognitive impairment or disorder that might confound study results and/or contraindicate subject’s participation in the study, in the opinion of the clinician. |
Conduct of interviews
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What does this [instruction/question/response option] mean to you?
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Can you put this [instruction/question/response option] into your own words?
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What made you choose [response selected by subject]?
Coding and analysis
Results
Study sample
Total (N = 15) n (%)a | |
---|---|
Age (years) | |
Range | 45.3–87.6 |
Mean (standard deviation) | 66.0 (12.4) |
Gender | |
Femaleb | 15 (100.0%) |
Spanish/Hispanic/Latino ethnicity | |
Not Spanish/Hispanic/Latino | 14 (93.3%) |
Mexican/Mexican American, Chicano | 1 (6.7%) |
Race | |
Black or African American | 6 (40.0%) |
White/Caucasian | 8 (53.3%) |
Other | 1 (6.7%) |
Education | |
High school diploma (or GED) or less | 0 (0.0%) |
Some college or certificate program | 7 (46.7%) |
College or university degree (two- or four-year) | 5 (33.3%) |
Graduate degree | 1 (6.7%) |
Other | 2 (13.3%) |
Living status | |
Living with family or friends | 13 (86.7%) |
Living alone | 2 (13.3%) |
Annual household income | |
Under $25,000 | 1 (6.7%) |
$25,000 to $49,999 | 6 (40.0%) |
$50,000 to $74,999 | 3 (20.0%) |
$75,000 to $99,999 | 1 (6.7%) |
$100,000 and over | 1 (6.7%) |
Prefer not to answer | 3 (20.0%) |
Work statusc | |
Working full-time | 4 (26.7%) |
Working part-time | 2 (13.3%) |
Homemaker | 1 (6.7%) |
Retired | 7 (46.7%) |
Unemployed | 1 (6.7%) |
Receiving disability benefits | 1 (6.7%) |
Health in general | |
Excellent | 0 (0.0%) |
Very good | 0 (0.0%) |
Good | 8 (53.3%) |
Fair | 5 (33.3%) |
Poor | 2 (13.3%) |
Other health conditionsc | |
Heart disease | 1 (6.7%) |
High blood pressure | 8 (53.3%) |
High cholesterol | 2 (13.3%) |
Pain | 6 (40.0%) |
Muscle pain | 4 (26.7%) |
Neuropathic pain | 2 (13.3%) |
Other pain | 1 (6.7%) |
Diabetes | 2 (13.3%) |
Type 2 |
2 (13.3%)
|
Thyroid disease | 1 (6.7%) |
Depression/anxiety | 6 (40.0%) |
None | 2 (13.3%) |
Other | 4 (26.7%) |
Total (N = 15) n (%) | |
---|---|
Menopausal status | |
Pre-menopausal | 3 (20.0%) |
Not on gonadotropin-releasing hormone (GnRH) agonist treatment |
3 (100.0%)
|
Post-menopausal | 12 (80.0%) |
Mammalian target of rapamycin (mTOR) inhibitor treatment | |
Yes | 3 (20.0%) |
No | 12 (80.0%) |
Recurrent or progressive disease refractory to non-steroidal aromatase inhibitor (NSAI), tamoxifen, or fulvestrant | |
Yes | 6 (40.0%) |
No | 9 (60.0%) |
Eastern Cooperative Oncology Group (ECOG) score | |
0 | 1 (6.7%) |
1 | 11 (73.3%) |
2 | 3 (20.0%) |
Cyclin-dependent kinase (CDK4/6) inhibitor treatment | |
Yes | 5 (33.3%) |
No | 10 (66.7%) |
Metastatic sitea | |
Bone | 13 (86.7%) |
Lung | 2 (13.3%) |
Liver | 3 (20.0%) |
Lymph node | 1 (6.7%) |
Skin | 1 (6.7%) |
Cognitive debriefing interview results
National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16)
Item, instruction, or response option | Number of patients (n,%)a | Exemplary quotes demonstrating patient understanding of instruction or item concept |
---|---|---|
Instructions: Below is a list of statements that other people with your illness have said are important. Please circle or mark one number per line to indicate your response as it applies to the past 7 days. | ||
Item was understood by patient | 14/14 (100%) |
“To read the question and circle number zero through four depending on which pertains to the activity you’ve had in the last week.”
|
Concept was experienced by patient | – | |
Item 1: I have a lack of energy | ||
Item was understood by patient | 13/13 (100.0%) |
“… I am very active, but my energy level is not where it was before I started going through this whole process dealing with, um, cancer. So that’s why I pick a little bit because even during the regular day I don’t feel that I’m at 100%. I’m feeling a little low on the energy.”
|
Concept was experienced by patient | 15/15 (100.0%) | |
Item 2: I have pain | ||
Item was understood by patient | 14/14 (100.0%) |
“And that was because I was telling you, um, under my left arm from the lymph nodes I always have pain there. It’s not really bad. It’s probably like a three. And I have pain in my injection spots. And that lasts throughout the whole month almost. So I still have pain or soreness in those areas. So that’s why I picked a little bit.”
|
Concept was experienced by patient | 12/15 (80.0%) | |
Item 3: I feel ill | ||
Item was understood by patient | 14/15 (93.3%) |
“Just not feeling well. You know, um, just feeling sick.”
|
Concept was experienced by patient | 12/14 (85.7%) | |
Item 4: I have been short of breath | ||
Item was understood by patient | 15/15 (100.0%) |
“I lose my breath quite a bit when I go up and down the stairs.… Or I walk outside. … Phew, it takes your breath away.”
|
Concept was experienced by patient | 12/14 (85.7%) | |
Item 5: Because of my physical condition, I have trouble meeting the needs of my family | ||
Item was understood by patient | 15/15 (100.0%) |
“Uh, it’s just my husband and I so, um, uh, it’s difficult because I can’t do what I used to do. You know, you have to depend on people. Um, but I try to do what I can.… Yeah. ‘Cause I push myself.… So I’m going to say somewhat.… getting stuff ready. Even though he cooks, you know, I will try to fix the salad or get things ready. Get our plates ready and sometimes that’s difficult.”
|
Concept was experienced by patient | 13/14 (92.9%) | |
Item 6: I feel fatigued | ||
Item was understood by patient | 14/14 (100.0%) |
“Q: And what does fatigue mean to you? A: Drained, tired, achy, lethargic.”
|
Concept was experienced by patient | 14/14 (100.0%) | |
Item 7: I have bone pain | ||
Item was understood by patient | 12/12 (100.0%) |
“I would say if you had bone pain, that means the cancer has gotten into your bones and your bones are actually aching and cancer hasn’t gotten into my bones …”
|
Concept was experienced by patient | 8/14 (57.1%) | |
Item 8: I am sleeping well | ||
Item was understood by patient | 15/15 (100.0%) |
“And I answered that like that because, um, sometimes when I go to sleep I wake up in the middle of the night and I can’t go back to sleep. And then sometimes, um, even when I’m feeling tired like I’m sleepy, sometimes I can’t even go to sleep. So I might just stay up and try to watch TV until my body just decides to doze off. So that’s what I mean, but I, I’m really not sleeping well. Even when I’m – when I am asleep it’s like I can literally feel myself tossing and turning. It’s not like a just relaxed sleep.”
|
Concept was experienced by patient | 12/14 (85.7%) | |
Item 9: I worry that my condition will get worse | ||
Item was understood by patient | 14/14 (100.0%) |
“Because I’ve had it and it hasn’t gotten any worse. So it could get worse, but it’s not something to worry about right now. Q: Okay. Um, and when – let’s see, when it says worry my condition will get worse, what does that mean to you? A: That I constantly think about it, which I don’t.”
|
Concept was experienced by patient | 12/14 (85.7%) | |
Item 10: I have nausea | ||
Item was understood by patient | 11/12 (91.7%) |
“That I want to throw up. That you feel like throwing up…”
|
Concept was experienced by patient | 9/14 (64.3%) | |
Item 11: I have mouth sores | ||
Item was understood by patient | 14/14 (100.0%) |
“Um, like canker sores or something that maybe the treatment has caused a, a soreness or an open wound in your mouth.”
|
Concept was experienced by patient | 6/14 (42.9%) | |
Item 12: I am bothered by side effects | ||
Item was understood by patient | 14/14 (100.0%) |
“I am bothered, uh, somewhat, I wish they would go away.… Side effects, um, side effects of the treatments. Examples, uh, stiffness, vomiting, uh, hair loss, those are side effects of the treatment that I have taken.”
|
Concept was experienced by patient | 10/15 (66.7%) | |
Item 13: I am bothered by hair loss | ||
Item was understood by patient | 14/14 (100.0%) |
“I am bothered by hair loss. Not really. Not at all because I was told that it would happen. Q: Okay. Um, and what does, what does hair loss mean to you? A: That my hair would fall out.”
|
Concept was experienced by patient | 9/14 (64.3%) | |
Item 14: I am able to work (include work at home) | ||
Item was understood by patient | 15/15 (100.0%) |
“Um, going to your job that – your employment, um, or working at home would be just general chores, um, housework, cooking, things of that nature.”
|
Concept was experienced by patient | 15/15 (100.0%) | |
Item 15: I am able to enjoy life | ||
Item was understood by patient | 15/15 (100.0%) |
“I’m beyond everything right now as far as I don’t let the aches and pains bother me. I mean I’ll grumble about them, but I’ll get past them. So for me that’s a four. Q: And what does enjoy life mean to you? A: Getting out and doing what you want to do or not letting someone tell you, you can’t do it because you had cancer or trying to – in their eyes being helpful, but in your eyes kind of not allowing you to do something just let you try it.”
|
Concept was experienced by patient | 11/12 (91.7%) | |
Item 16: I am content with the quality of my life right now | ||
Item was understood by patient | 15/15 (100.0%) |
“Quality of life, being able to get around without anybody, with aid, that’s a quality of life, to live the life you lived before chemo. … I’m content with and always say it is more important to have a quality of life instead of a quantity of it. So if, ah, all went bad and I, and cancer would take over, ah, I would have that to, ah, evaluate it and say what about quantity, living and not being able to do, have, to do the things I want to do.”
|
Concept was experienced by patient | 11/12 (91.7%) | |
Response options | ||
Response option “Not at all” understood by patient | 12/13 (92.3%) | – |
Response option “A little bit” understood by patient | 10/14 (71.4%) | – |
Response option “Somewhat” understood by patient | 11/11 (100.0%) | – |
Response option “A lot” understood by patient | 11/13 (84.6%) | – |
Response option “Very much” understood by patient | 9/11 (81.8%) | – |
Overall | ||
Patient reported NFBSI-16 is easy to complete | 12/13 (92.3%) | – |
Patient reported that there are no missing concepts | 11/14 (78.6%) |
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b
Item, instruction, or response option | Number of patients (n,%)a | Exemplary quotes demonstrating patient understanding of instruction or item concept |
---|---|---|
Instructions: Please respond to each question or statement by marking one box per row. | ||
Item was understood by patient | 14/14 (100%) |
“It says read each question or the statement and mark, and marking one box per row. It means it’s asking me to read the question and mark one box on my answers.”
|
Concept was experienced by patient | – | |
Item 1: Are you able to do chores such as vacuuming or yard work? | ||
Item was understood by patient | 15/15 (100.0%) |
“Unable to do, number 1. Q: Okay, and why do you choose unable to do? A: Because vacuuming, I can vacuum only if I’m in my wheelchair or walker, and then yard work, it is too hot to do yard work.… Chores, ah, washing dishes, cooking, vacuuming, mopping, dish, ah, laundry.”
|
Concept was experienced by patient | 14/15 (93.3%) | |
Item 2: Are you able to get in and out of a car? | ||
Item was understood by patient | 14/14 (100.0%) |
“Okay, like if you go to the grocery store, can you get in that car? Can you put all your groceries in your car, can you get in without need assistance? I don’t need any assistance to get in and I don’t need any assistance to get out.”
|
Concept was experienced by patient | 11/14 (78.6%) | |
Item 3: Are you able to go up and down stairs at a normal pace? | ||
Item was understood by patient | 15/15 (100.0%) |
“Are you able to go up and down stairs at a normal pace? Um, going down is okay. Going up, it’s very difficult. Q: What is it about going up that is difficult? A: I can’t breathe. Q: … in this question what does a normal pace mean to you? A: Just walking at a, um, normal speed.”
|
Concept was experienced by patient | 13/15 (86.7%) | |
Item 4: Are you able to run errands and shop? | ||
Item was understood by patient | 13/13 (100.0%) |
“Run errands and shop, uh, go to the cleaners, put gas in their car, go do this, go do that, and do the groceries. You just don’t have it in you.”
|
Concept was experienced by patient | 12/15 (80.0%) | |
Item 5: Are you able to bend down and pick up clothing from the floor? | ||
Item was understood by patient | 15/15 (100.0%) |
“We’re going to go with some difficulty on that depending on how far away the floor is. I actually have little grabbers that I keep in different rooms of the house so that I can reach down and grab things with.… if I have to physically bend down and pick it up it’s more of a challenge for me to grab it and get up. Um, if it’s rounded up and if I can just reach down a little easier I can grab it that way. But if it’s something flat on the floor it’s just a, a nuisance for me. It’s, it’s kind of midrange. I can do it, but do I want to do it? No.”
|
Concept was experienced by patient | 12/14 (85.7%) | |
Item 6: Are you able to lift 10 pounds (5 kg) above your shoulder? | ||
Item was understood by patient | 11/11 (100.0%) |
“Either pick up from a table or something that’s handed to me and then raise it up maybe to a shelf or, or move it from one position to another that really wouldn’t be above my shoulders but, um, just moving that object from where it was to where it’s going to. Not necessarily like a bench press or something like that like raising weights.”
|
Concept was experienced by patient | 11/12 (91.7%) | |
Item 7: Does your health now limit you in doing vigorous activities, such as running, lifting heavy objects, participating in strenuous sports? | ||
Item was understood by patient | 13/14 (92.9%) |
“I cannot run, I cannot lift anything, and I cannot participate in sports, so I cannot do any of that.”
|
Concept was experienced by patient | 13/15 (86.7%) | |
Item 8: Does your health now limit you in bathing or dressing yourself? | ||
Item was understood by patient | 13/13 (100.0%) |
“Because you need help with helping wash your back and sometimes pulling up pants or zipping objects.”
|
Concept was experienced by patient | 13/14 (92.9%) | |
Item 9: Does your health now limit you in putting a trash bag outside? | ||
Item was understood by patient | 11/12 (91.7%) |
“Can you lift that trash bag out of that trash can and take it to the dumpster or take it to the big trashcan outside, the garbage can.”
|
Concept was experienced by patient | 8/14 (57.1%) | |
Item 10: Does your health now limit you in doing moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf? | ||
Item was understood by patient | 15/15 (100.0%) |
“I don’t bowl or play golf. I couldn’t get in the heat or that kind of weather or anything. I don’t do any moderate activities. Moving a table, no, I would never attempt that.… Um, so there’s only one in there I would do.… With some difficulty, the vacuum.… Yeah. I couldn’t pick up a bowling ball and golf I wouldn’t get out in the heat or the sun.… And, um, picking up a table, I’m not going to pick up a table either. I don’t have the strength for that.”
|
Concept was experienced by patient | 10/12 (83.3%) | |
Response options | ||
Response option “Without any difficulty” understood by patient | 15/15 (100.0%) | – |
Response option “With some difficulty” understood by patient | 13/13 (100.0%) | – |
Response option “With much difficulty” understood by patient | 15/15 (100.0%) | – |
Response option “Unable to do” understood by patient | 15/15 (100.0%) | – |
Response option “Not at all” understood by patient | 7/14 (50.0%) | – |
Response option “Very little” understood by patient | 3/12 (25.0%) | – |
Response option “Somewhat” understood by patient | 8/10 (80.0%) | – |
Response option “Quite a lot” understood by patient | 6/10 (60.0%) | – |
Response option “Cannot do” understood by patient | 13/13 (100.0%) | – |
Overall | ||
Patient reported PROMIS is easy to complete | 15/15 (100.0%) | – |
Patient reported that there are no missing concepts | 11/13 (84.6%) |