A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial.

PURPOSE: Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their prognosis and treatment risk. While decision aids can improve illness understanding and reduce decisional conflict, there are no validated decision aids for AML. We developed and tested a novel AML decision aid (NCT03442452). METHODS: Patients (n = 20) were recruited at Duke University from May 2018 to February 2019. Participants completed assessments of AML knowledge and decisional conflict, before and after using the electronic decision aid. The primary endpoint was feasibility (endpoint met if > 80% of study participants completed all study components). Secondary analyses of efficacy were conducted using paired t tests for dependent pre-/post-samples. RESULTS: The primary endpoint of feasibility was met (100% of participants completed all study components). Secondary analyses showed improved knowledge and reduced decisional conflict after using the decision aid. Knowledge scores improved from a mean of 11.8 (out of 18) correct items at baseline to 15.1 correct items after using the decision aid (mean difference 3.35; p < 0.0001). Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02). CONCLUSION: These findings suggest that our AML decision aid is a useful tool to improve the patient experience and promote shared decision-making in AML. A randomized efficacy trial is planned.

Patient experiences of acute myeloid leukemia: A qualitative study about diagnosis, illness understanding, and treatment decision-making.

BACKGROUND: Patients with acute myeloid leukemia (AML) face a unique, difficult situation characterized by sudden changes in health, complex information, and pressure to make quick treatment decisions amid sizeable tradeoffs. Yet, little is known about patients' experiences with AML. We used qualitative methods to learn about their experiences with diagnosis and treatment decision-making to identify areas for improvement. METHODS: We recruited hospitalized patients with AML to participate in semi-structured qualitative interviews about their experiences being diagnosed with AML, receiving information, and making a treatment decision. Interviews were conducted during their hospitalization for induction chemotherapy. We analyzed data by using a constant comparison approach. RESULTS: Thirty-two patients completed an interview. Four main themes emerged: (a) shock and suddenness, (b) difficulty processing information, (c) poor communication, and (d) uncertainty. Patients frequently described their diagnosis as shocking. They also felt that the amount of information was too great and too difficult to process, which negatively impacted their understanding. Patients frequently described a lack of emotional support from clinicians and described uncertainty about their prognosis, the number and nature of available treatments, and what to expect from treatment. CONCLUSIONS: Acute myeloid leukemia poses a sudden, emotionally challenging, information-laden situation, where little time is available to make important decisions. This results in difficulty processing information and is sometimes complicated by a lack of emotive communication from clinicians. Results indicate a need for targeted interventions to improve AML patients' understanding of illness and treatment options and to address their traumatic experiences around diagnosis.

Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers.

OBJECTIVE: Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states. METHODS: We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics. RESULTS: Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE. CONCLUSIONS: This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Utility scores and treatment preferences for clinical early-stage cervical cancer.

OBJECTIVES: To determine utility scores for health states relevant to the treatment of early-stage, high-risk cervical cancer. METHODS: Seven descriptive health states incorporating the physical and emotional aspects of medical treatment, recovery, and prognosis were developed. Forty-five female volunteers valuated each health state using the visual analogue score (VAS) and time trade off (TTO) methods. Treatment options were ranked by mean and median TTO scores. The 95% confidence intervals were calculated to determine the statistical significance of ranking preferences. The Wilcoxon rank-sum test was used to compare central tendencies related to age, race, parity, and subject history of abnormal cervical cytology. RESULTS: VAS and TTO scores were highly correlated. Volunteers ranked minimally invasive radical hysterectomy with low-risk features as most preferred (mean TTO = 0.96; median TTO = 1.00) and aborted radical hysterectomy followed by chemoradiation as least preferred (mean TTO = 0.69; median TTO = 0.83). Health states that included radical surgery were ranked higher than those that included chemoradiation, either in the adjuvant or primary setting. When survival was comparable, volunteers rated radical hysterectomy with high-risk pathology followed by adjuvant chemoradiation (mean TTO = 0.78; median TTO = 0.92; 95% CI: 0.69-0.87) similarly to chemoradiation alone (mean TTO = 0.76; median TTO 0.90; 95% CI: 0.66-0.86; p = NS). Utility scores for the majority of health states were not significantly associated with age, race, parity, or subject history of abnormal cervical cytology. CONCLUSION: Subjects consistently preferred surgical excision to treat early-stage, high-risk cervical cancer and chose a minimally invasive approach. Such utility scores can be used to incorporate quality-of-life effects into comparative-effectiveness models for cervical cancer.

Determination of quality of life-related utilities for health states relevant to ovarian cancer diagnosis and treatment.

OBJECTIVES: (1) To define a set of health state descriptions related to screening, diagnosis, prognosis, and toxicities relevant to ovarian cancer; (2) To derive a set of quality of life-related utilities to be used for cost-effectiveness analyses. METHODS: A comprehensive list of health states was developed to represent the experiences of diagnostic testing for ovarian cancer, natural history of ovarian cancer (e.g., newly diagnosed early stage ovarian cancer, recurrent progressive ovarian cancer) and the most common chemotherapy-related toxicities (e.g. alopecia, peripheral neuropathy, pain, neutropenia, fatigue). Valuation of each health state was obtained through individual interviews of 13 ovarian cancer patients and 37 female members of the general public. Interviews employed visual analog score (VAS) and time trade off (TTO) methods of health state valuation. RESULTS: Mean TTO-derived utilities were higher than VAS-derived utilities by 0.118 U (p<0.0001). Mean VAS-derived utilities for screening tests were 0.83 and 0.81 for true negative blood test and ultrasound; 0.79 and 0.78 for false negative blood test and ultrasound, respectively. Patients and volunteers generally agreed in their preference ranking of chemotherapy-associated states, with lowest rankings being given to febrile neutropenia, grades 3-4 fatigue, and grades 3-4 nausea/vomiting. For 55% of chemotherapy-associated health states, the average utility assigned was higher for patients than for volunteers. CONCLUSIONS: This study establishes societal preferences for a number of health states related to screening, diagnosis and treatment of ovarian cancer that can be used for assessing the cost-effectiveness of different ovarian cancer screening and treatment regimens.