A total of twenty-three US and eighteen Japanese participants were interviewed (Table 2) in the period between January 23 and March 11, 2014. The overall sample consisted of 37% males and 63% females; the median age of those interviewed was 48 years. There were fifteen newly-diagnosed high-intensity participants, nine newly-diagnosed low-intensity participants, nine relapse/refractory participants, and eight post-transplant participants.
Saturation was evaluated retrospectively after forty-one participant interviews. We found that none of the most frequently occurring signs/symptoms or impacts were added after the first interview wave (eight interviews) in the US and the first interview wave in Japan (six interviews). Thus, saturation had been achieved after fourteen participant interviews and additional interviews were conducted to ensure adequate sample sizes in each subgroup.
Forty-eight unique signs/symptoms and twenty-four unique impacts of AML and its treatments were mentioned by US participants (Tables S1 and S2 in the supplementary material), and thirty-one unique signs/symptoms and twenty-one unique impacts were mentioned by Japanese participants (Tables S3 and S4 in the supplementary material). The most frequently mentioned signs/symptoms and impacts in each participant subgroup were the same as those mentioned in the overall participant sample (Tables S1–S4). By way of example, the most frequently mentioned sign/symptom in the US, fatigue, was reported by 10/10 newly-diagnosed, high-intensity participants, 4/4 newly-diagnosed, low-intensity participants, 3/3 relapse/refractory participants, and 5/6 post-transplant participants. In Japan, nausea was the most frequently mentioned sign/symptom and was reported by 5/5 newly-diagnosed, high-intensity participants, 4/5 newly-diagnosed, low-intensity participants, 6/6 relapse/refractory participants, and 2/2 post-transplant participants. Given the similarity of signs/symptoms and impacts reported in each of the subgroups, the results presented below will focus on comparisons and contrasts by region.
Here we present the signs/symptoms and impacts reported by at least 30% of participants in each subgroup and by 50% of the overall participant population. Signs/symptoms or impacts reported by less than 30% of any participant subgroup and by less than 50% of the overall population are included in the tables in the supplementary material.
Signs/Symptoms and Their Disturbance Effect on Participants’ Lives
The most commonly reported sign/symptom in the US sample was fatigue (95.7%; Table 3). One US patient said “It [fatigue] was horrible. I couldn’t do my normal, daily activities. I’m a stay-at-home mom. Even making dinner for my family, even as far as going to the bathroom, was difficult. It took a lot out of you to walk from a very short distance.” Other signs/symptoms reported by ≥50% of the US sample included: bruising, weakness, fever, anemia, diarrhea, dizziness, infection, nausea, mouth sores, shortness of breath, bleeding, and headache. Fatigue, fever, infection, nausea, and headache were the symptoms most often mentioned spontaneously by at least half of the respondents.
The most commonly reported symptom in the overall Japanese population was nausea (94.4%; Table 4). A Japanese participant contextualized their nausea as “I got fatigue and nausea as the side effects of anticancer drugs. Especially [caused] by the radiation therapy.” The signs/symptoms reported by ≥50% of the sample from Japan included fatigue, headache, shortness of breath, weakness, vomiting, bleeding, cardiovascular problems, dizziness, fever, poor healing, anemia, diarrhea, constipation, infection, and pain. Those concepts spontaneously reported by at least half of the respondents included fatigue, fever, infection, nausea, and headache.
Plots of disturbance ratings against frequency of concepts reported are presented in Figs. 1, 2, 3 and 4. The highest median disturbance ratings (range 0–10) for US participants were for signs/symptoms of fatigue, fever, infection, and mouth sores (scores of 7–8), followed by those for weakness, diarrhea, dizziness, nausea, shortness of breath, bleeding, headache, swollen/bleeding gums, and poor healing (scores of 5–6). A US patient described his fever and stated, “For about 3 days, I was having this fever and heart rates of about 150 beats per minute. And just felt awful, along with the rapid weight gain. The fever wasn’t responding to Tylenol, which was the only thing that they could give me because I had leukemia. I ended up having to be packed in ice packs about every 2 hours for about 3 days straight.” Another patient commented on his increased risk of infection noting, “I have susceptibility to infection. With the immune suppression medication, I also don’t want to be around crowds if I can avoid it because people equal sickness. The treatment, the immune suppression therapy is a big problem.”
The highest median disturbance ratings (range 0–10) for Japan participants were sign/symptom concepts of shortness of breath (score of 9), fatigue, weakness, infection, and pain (scores of 8 for all), headache and cardiovascular problems (scores of 7), and bleeding, dizziness, fever, and anemia (scores of 5–6). A Japanese patient described fatigue stating, “In the office fatigue was like less physical strength. I felt like I have suddenly aged 20 years.”
Impacts and Their Disturbance Effect on Participants’ Lives
The most commonly reported impact in the overall US sample was a decreased ability to maintain social/familial roles, with 91.3% of participants reporting the concept during interviewing (Table 3). A US patient said, “I can’t be the mom I used to be to my kids. That’s the worst part. I can’t run around and play with them anymore. I used to go outside and play catch with them. I used to play soccer with my son. I get tired out just doing anything with them anymore. I can’t go make cookies with my daughter anymore because it hurts to stand up for that long. I get tired out. I mean, it’s literally affected everything about my life.”
The impacts reported by ≥50% of the US sample included anxiety, decreased ability to function, financial difficulties, memory loss, problems concentrating, depression, fear, weight loss, remission uncertainty, and appetite loss. Those concepts spontaneously reported by at least half of the respondents included decreased ability to maintain social/familial roles and decreased ability to function. A US participant described decreased ability to function as, “I couldn’t continue the work I used to do. I used to be a medical transcriptionist. I couldn’t do that anymore because it affected my cognitive abilities and my word recall. I can’t do the same work that I did before.”
The most commonly reported impact for Japanese participants was anxiety (94.4%; Table 4). Other impacts reported by ≥50% of the sample from Japan included decreased ability to function, remission uncertainty, financial difficulties, appetite loss, decreased ability to maintain social/familial roles, fear, problems concentrating, risk of other cancer, and weight loss. Decreased ability to function was the only impact spontaneously reported by at least half of the respondents. A Japanese patient described this decreased ability to function as, “I felt I could not work and started to take time off from work. When I got home, I felt like I could not do anything.” Anxiety and remission uncertainty were discussed by another Japan participant as, “I felt very anxious [during treatment] because I could not meet my children and four cats… When my doctor started to administer anticancer drugs to me, it eased the symptoms. But I feel I cannot endure the side-effects of anticancer drugs if AML recurs. I am very anxious about it.”
The highest median disturbance ratings (range 0–10) for US participants were impact concepts of financial difficulties and depression (scores of 9 for both). A US participant noted that, “It was more just that you’re sitting around doing nothing. Couldn’t work. Couldn’t go anywhere. Not feeling good. I don’t think it was bad, but I guess I probably was depressed at times, yeah.” These were followed by decreased ability to maintain social/familial roles, decreased ability to function, anxiety, fear, remission uncertainty, and appetite loss (scores of 7–8), problems concentrating and memory loss (scores of 5–6).
The highest median disturbance ratings for Japanese participants (range 0–10) were impact concepts of remission uncertainty and risk of other cancer (scores of 10 for both). These were followed by decreased ability to maintain social/familial role (scores of 7–9), anxiety, decreased ability to function, financial difficulties, fear, and problems concentrating (scores of 5–6). In terms of decreased ability to maintain social/familial role, a Japanese participant said, “She [my wife] may be offended. Our marriage was arranged, so I am afraid that she may start thinking that she made a bad choice.”