Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
Brief summary
This randomized pilot clinical trial studies a home telemonitoring device in managing the care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are discharged from the hospital following chemotherapy. After treatment and hospital discharge, patients typically need extensive care to deal with the side effects of chemotherapy, keep up with medications, and obtain medical assistance. A home telemonitoring device would allow patients to monitor vital signs, symptoms, and use of medications, communicate with healthcare providers, and access educational material. A telemonitoring device may allow patients to be managed more effectively than standard outpatient care after being discharged from the hospital.
Detailed description
PRIMARY OBJECTIVES: I. To determine the feasibility of home telemonitoring for adult patients following intensive induction, re-induction/salvage, or consolidation chemotherapy for myelodysplastic syndrome (MDS) or non-acute promyelocytic leukemia (APL) acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. To estimate the impact of the telemonitoring intervention on mortality, duration of hospital stay, use of emergency services, visits to primary care physicians and to specialists, home visits, and telephone calls (health care resource utilization). II. To evaluate the telemonitoring procedure in economic terms compared to usual care through a cost-effectiveness analysis. III. To estimate the impact on the quality of life of study participating. IV. To assess the degree of satisfaction of the patients/caregivers and health care professionals with the telemonitoring intervention. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (CONTROL): Patients receive standard outpatient supportive care after completion of chemotherapy. ARM II (INTERVENTION): Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).
Interventions
DEVICEHealth Telemonitoring
Use home telemonitoring device
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESupportive Care
Receive standard outpatient supportive care
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of MDS or AML other than APL with t(15;17)(q22;q12), (promyelocytic leukemia\[PML\]/retinoic acid receptor \[RAR\]), or variants according to the 2008 World Health Organization (WHO) classification * Patient is currently undergoing AML-like intensive induction, re-induction/salvage, or consolidation chemotherapy, or planned to start such therapy within 1 week * Willingness to have close follow-up and treatment at the Clinic at the Seattle Cancer Care Alliance (SCCA) or at a local facility; typically, patients will be seen at least 3 times per week as per standard practice, including at least once weekly at the SCCA * Permanent or temporary housing available within a 60 minute (min) commute from the SCCA * Available caregiver * Willingness and ability to use the telemonitoring device * Provision of written informed consent
Exclusion criteria
* Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients willing to use the in-home telemonitoring device | Up to 4 weeks | Exploratory, descriptive and observational methods will be used to determine enrollment and retention issues in AML/MDS patients who are discharged early after intensive chemotherapy. |
| Success of data transmission | Up to 4 weeks | Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of satisfaction of health care professionals with the telemonitoring intervention | Up to 4 weeks (at end of study period) | Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms. |
| Quality of life (QOL) as assessed by the M.D. Anderson Symptom Inventory Core items and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 | Up to 4 weeks (at end of study period) | Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL. |
| Changes in patient conditions | Up to 4 weeks | Researchers' ability to use the transmitted data to support patients in recognizing changes in their conditions and managing the changes or getting appropriate medical assistance will be estimated between study arms using exploratory, descriptive, and observational methods. |
| Mortality | Up to 4 weeks | The impact of the telemonitoring intervention on mortality compared to the control group will be estimated. |
| Health care resource utilization | Up to 4 weeks | Descriptive and observational methods will be used to estimate the impact of the telemonitoring intervention with regard to health care resource utilization, and data on rehospitalization (frequency, duration, resource use, and need for intensive care unit-level care). |
| Percentage of returned surveys | Up to 4 weeks | Percentage of returned surveys will be measured as a feasibility outcome. |
| Degree of satisfaction of the patients/caregivers with the telemonitoring intervention | Up to 4 weeks (at end of study period) | Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms. |
Countries
United States
Outcome results
None listed