Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy

Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy

Integrating a Telemonitoring Device Into the Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML: A Randomized Pilot Study

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.

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).

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).

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.

Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.

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.

Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.

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

Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL.

The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.

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).

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