Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Women's Studies, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/7/2019 |
| Start Date: | January 9, 2015 |
| End Date: | February 1, 2020 |
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.
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).
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).
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
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Anna Halpern
Phone: 206-667-6233
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