Integrating a Telemonitoring Device Into the Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML: A Randomized Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Proportion of patients willing to use the in-home telemonitoring device
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Arm I (standard outpatient supportive care)
Patients receive standard outpatient supportive care after completion of chemotherapy.
Intervention: Quality-of-Life Assessment (Other)
Arm I (standard outpatient supportive care)
Patients receive standard outpatient supportive care after completion of chemotherapy.
Intervention: Questionnaire Administration (Other)
Arm I (standard outpatient supportive care)
Patients receive standard outpatient supportive care after completion of chemotherapy.
Intervention: Supportive Care (Procedure)
Arm II (home telemonitoring device)
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).
Intervention: Health Telemonitoring (Device)
Arm II (home telemonitoring device)
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).
Intervention: Quality-of-Life Assessment (Other)
Arm II (home telemonitoring device)
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).
Intervention: Questionnaire Administration (Other)
Arm II (home telemonitoring device)
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).
Intervention: Supportive Care (Procedure)
Outcomes
Primary Outcomes
Proportion of patients willing to use the in-home telemonitoring device
Time Frame: 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
Time Frame: Up to 4 weeks
Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.
Secondary Outcomes
- 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))
- Percentage of returned surveys(Up to 4 weeks)
- Changes in patient conditions(Up to 4 weeks)
- Mortality(Up to 4 weeks)
- Degree of satisfaction of the patients/caregivers with the telemonitoring intervention(Up to 4 weeks (at end of study period))
- Degree of satisfaction of health care professionals with the telemonitoring intervention(Up to 4 weeks (at end of study period))
- Health care resource utilization(Up to 4 weeks)