Abstract
Abstract
Background:
Acute myeloid leukemia (AML) is one of the most common types of leukemia in adults, but there is limited information on survivors' quality of life (QOL) after remission.
Objective:
We piloted a survey exploring patient-reported outcomes for people with AML in first complete remission (CR1) to determine whether patients felt the survey is relevant to their well-being and to summarize patient characteristics.
Design/Measurements:
Cross-sectional survey of a convenience sample of AML patients in CR1 assessing QOL and functioning (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 v 3.0), well-being (QOL-cancer survivor [QOL-CS]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), and anxiety and depression (hospital anxiety and depression scale [HADS]). The survey contained five open-ended questions.
Results:
Eighteen patients completed the survey. Most felt it was completely or mostly relevant (88.8%) in describing their QOL. Participants scored well on the EORTC QLQ-C30, fatigue being the most common symptom (83%).The FACIT-Fatigue mean score was 28.7 and median score was 33.5 (normal ≥30). Two scored in the abnormal range for anxiety and one for depression on the HADS. On the QOL-CS, participants scored more than 6 out of 10 in most domains, except the subscales of distress and fear.
Conclusions:
The survey content and length were appropriate. Patients reported ongoing fatigue, fears of future test results, getting a second cancer, and recurrence of cancer. Survivors experience ongoing symptoms, highlighting the importance of providers performing ongoing symptom and needs assessments.
Background
A
Reviews assessing the impact of AML and its treatments on quality of life (QOL) described studies with wide variations in instruments used for outcome assessment.4,5 To better understand the QOL among AML survivors, we piloted a survey for patients in first complete remission (CR1)—the survey package consists of validated instruments, five open-ended questions, and participant feedback questions. The primary objective was to determine whether patients felt the survey package was relevant to their well-being and whether the length was appropriate. The exploratory objectives were to summarize patient QOL outcome using previously validated instruments measuring symptom burden, depression, anxiety, and well-being to inform future prospective studies.
Methods
The study received Institutional Review Board approval for a cross-sectional survey of AML patients at the Sidney Kimmel Comprehensive Cancer Center. Recruitment was between March and July 2013 in the outpatient clinics.
Adults between the ages of 18 and 65 years diagnosed with AML and in CR1 were eligible. After verbal consent, participants were given a self-administered questionnaire and compensated with a $25 gift card.
Survey instrument
The questionnaire consisted of seven sections:
(1) The European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30 v.3.0) covering five functioning domains (physical, role, emotional, cognitive, social, and global) and symptoms.
6
(2) The 40-item QOL-CS scale assessing physical, psychological, spiritual well-being, and social concerns of cancer survivors. The QOL-CS psychological subscale contains two subcomponents assessing patients' perceived amount of distress and fear.
7
(3) The 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale version 4.8,9 (4) The 14-item hospital anxiety and depression scale (HADS).
10
(5) Five qualitative questions. (6) Sociodemographic information, medical history, and exercise history using the Godin Leisure-Time Exercise Questionnaire.
11
(7) Participant feedback questions: three questions regarding the primary objective of the survey: “How relevant did you find the questions in this questionnaire in understanding your quality of life,” “What do you think about the length of this questionnaire,” and “Any additional suggestions or comments?”
Statistical methods
Participant characteristics were summarized using descriptive statistics. Validated measures were scored according to scoring guidelines. For each scale, a summary score was calculated. For some scales, scores were calculated within specific domains (i.e., distress and fear subcomponents). Patient QOL scores were summarized by duration of CR (short-term CR was defined as less than two years and long-term CR was defined as two years or more).
The five open-ended responses were analyzed using the grounded theory approach. Responses were independently reviewed by the first author and coauthor (A.M.), using a line-by-line process to generate preliminary coding categories. 12 Responses were independently reviewed and coded. The responses were compared and consensus was reached and themes generated.
Results
Twenty patients were approached, and 18 completed the survey. Participants' mean and median age were 57.2 and 59.5 years, respectively. Nine patients were in CR for less than two years, and nine were in CR for two years or more. Eleven patients (61%) underwent stem cell transplant and six reported chronic graft-versus-host disease (GVHD) (Table 1).
GVHD, graft-versus-host disease.
Eight participants felt the survey was completely relevant (44.4%) and eight felt mostly relevant (44.4%) in understanding their QOL. Fourteen felt the length of the survey was optimal (77.8%), three (16.7%) felt it was somewhat too long, and one participant felt it was too short. Participant comments are provided in Table 2.
In the EORTC QLQ-C30 questionnaire, participants scored the best in physical function (mean [standard deviation (SD)] = 86.3 [12.6]) and worst in cognitive function (mean [SD] = 77.8 [20.6]). Listed symptoms reported ranged from 11% (constipation) to 83% (fatigue). (Table 3).
EORTC, European Organization for Research and Treatment of Cancer; FACIT–Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; HADS, hospital anxiety and depression scale; QOL-CS, quality of life-cancer survivor; SD, standard deviation.
The mean score (SD) on the FACIT-Fatigue (worst 0, best 52, normal ≥30) was 28.7 (12.6) and median score (range) was 33.5 (2–43) (Table 3).
On the HADS anxiety score, two participants scored in the borderline range and two in the abnormal range. On the HADS score, one participant scored in the abnormal range (Table 3).
The mean scores for all participants in the QOL-CS questionnaire (worst 0, best 10) were more than six in all four well-being domains, with the exceptions of the psychological subscales of distress and fear (Table 3).
In the fear subscale, participants in both CR groups reported similarly when asked (1) To what extent are you fearful of future diagnostic tests (CR <2 years mean 5.2, CR ≥2 years mean 5.6); (2) To what extent are you fearful of a second cancer (CR <2 years mean 4.7; CR ≥2 years mean 5.6); (3) To what extent are you fearful of recurrence of your cancer (CR <2 years mean 6; CR ≥2 years mean 5.8).
In the Godin exercise questionnaire, 13 participants (76.5%) reported not engaging in strenuous activity any day of the week. When asked, “During a typical 7-Day period, in your leisure time, how often do you engage in any regular activity long enough to work up a sweat (heart beats rapidly)?” three, five, and nine participants reported working up a sweat often, sometimes, and rarely or never working up a sweat, respectively.
All 18 participants completed five open-ended questions. Themes and sample responses are given in Table 4.
Conclusions
In this pilot study of AML survivors in CR1, most participants felt the content and length of the survey were appropriate. Most scored well on physical, emotional, role, cognitive, and social function scores. Although it is difficult to generalize the findings of this study because of the small sample size, our results are similar to prior studies assessing QOL of patients in CR1.13,14 Our study incorporated additional validated scales with cancer survivor-specific questions, symptoms of interest, and open-ended questions.
Fatigue continues to be one of the most common symptoms that persists despite being in disease remission. Although the etiology is multifactorial,15–18 we wanted to better understand survivors' activity levels and exercise patterns because these can have health implications.19,20 Our study suggests that both short-term and long-term CR patients are not as likely to engage in any regular activity long enough to work up a sweat. Whether this holds true in a larger sample and whether activity level correlates with fatigue is an area for further exploration.
Our results raise the question of whether there is a population of cancer survivors who are coping less well. A theme observed in both the quantitative and qualitative responses is an ongoing fear of future diagnostic test results, developing a second cancer and the recurrence of cancer. In the cancer survivorship literature, FCR is one of the most frequently cited area of unmet need.21,22 FCR has been associated with psychological factors such as distress, anxiety, and depression.23,24
Black and White examined the relationship between FCR and post-traumatic stress symptomatology (PTSS) in hematological cancer survivors. They found that FCR correlated positively with PTSS and 17% of the sample met DSM-IV criteria for post-traumatic stress disorder. 25 Further qualitative evaluations may better elucidate when FCR shifts from normal fear to interfering with everyday life.
It will also be informative to interview survivors who experienced serious illness in a positive life-transforming way as was hinted by some of the themes from the open-ended questions. Qualitative studies in other populations reported a phenomenon wherein participants reported subjective changes in response to life-threatening illnesses, leading to personal growth.26,27 One hypothesis is that the ability to experience illness in a transformative manner is protective against clinically significant distress. Finally, it is vital to note that even long-term survivors can continue to report ongoing symptoms and the importance of ongoing symptom and needs assessments.
There are several limitations to this study. The primary objective was to determine whether participants think the survey was relevant to their overall well-being and whether the length was appropriate before its use in prospective studies and was not designed to assess the activity of individual subgroups. The cross-sectional survey of a convenience sample also limits firm conclusions. The sample was small and demographically homogeneous. More than half of the participants have undergone a stem cell transplant. Since GVHD can have a profound impact on survivors' QOL, better characterization of those who developed chronic GVHD would have provided a fuller description of the burden of GVHD, including its impact on fatigue. Future studies should plan for separate chemotherapy-only and post-transplant groups as these are distinct populations in terms of disease risk, treatment course, and complications. Despite these limitations, this study is an initial step toward using this survey for better understanding of AML survivors' health and well-being.
Footnotes
Acknowledgments
The authors thank Dr. Amy Dezern and nurse practitioner Valerie Ironside for assisting with participant recruitment. This research was supported in part by the Intramural Research Program of the NIH, Clinical Center, and the National Heart Lung and Blood Institute.
Author Disclosure Statement
No competing financial interests exist.
