Clinical trial NCT02226497: Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy
Official title: Integrating a Telemonitoring Device Into the Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients willing to use the in-home telemonitoring device
timeFrame: Up to 4 weeks
measure: Success of data transmission
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Changes in patient conditions
timeFrame: Up to 4 weeks
measure: Degree of satisfaction of the patients/caregivers with the telemonitoring intervention
timeFrame: Up to 4 weeks (at end of study period)
measure: Degree of satisfaction of health care professionals with the telemonitoring intervention
timeFrame: Up to 4 weeks (at end of study period)
measure: 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
timeFrame: Up to 4 weeks (at end of study period)
measure: Percentage of returned surveys
timeFrame: Up to 4 weeks
measure: Mortality
timeFrame: Up to 4 weeks
measure: Health care resource utilization
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Anna Halpern
role: PRINCIPAL_INVESTIGATOR
References: