Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome
- Interventions
- Device: Health TelemonitoringOther: Questionnaire AdministrationOther: Quality-of-Life AssessmentProcedure: Supportive Care
- Registration Number
- NCT02226497
- Lead Sponsor
- Fred Hutchinson Cancer Center
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- Cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (standard outpatient supportive care) Questionnaire Administration Patients receive standard outpatient supportive care after completion of chemotherapy. Arm I (standard outpatient supportive care) Supportive Care Patients receive standard outpatient supportive care after completion of chemotherapy. Arm II (home telemonitoring device) Quality-of-Life Assessment 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). Arm I (standard outpatient supportive care) Quality-of-Life Assessment Patients receive standard outpatient supportive care after completion of chemotherapy. Arm II (home telemonitoring device) Questionnaire Administration 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). Arm II (home telemonitoring device) Health Telemonitoring 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). Arm II (home telemonitoring device) Supportive Care 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Percentage of returned surveys Up to 4 weeks Percentage of returned surveys will be measured as a feasibility outcome.
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.
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.
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.
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).
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States