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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02226497
• Other study ID #: 9105
• Secondary ID: NCI-2014-01680FH
• Status: Terminated
• Phase: N/A
• Start date: January 9, 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2020
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Device:
• Health Telemonitoring
Use home telemonitoring device

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Supportive Care
Receive standard outpatient supportive care

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients willing to use the in-home telemonitoring device	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.	Up to 4 weeks
Primary	Success of data transmission	Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.	Up to 4 weeks
Secondary	Changes in patient conditions	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.	Up to 4 weeks
Secondary	Degree of satisfaction of the patients/caregivers with the telemonitoring intervention	Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.	Up to 4 weeks (at end of study period)
Secondary	Degree of satisfaction of health care professionals with the telemonitoring intervention	Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.	Up to 4 weeks (at end of study period)
Secondary	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.	Up to 4 weeks (at end of study period)
Secondary	Percentage of returned surveys	Percentage of returned surveys will be measured as a feasibility outcome.	Up to 4 weeks
Secondary	Mortality	The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.	Up to 4 weeks
Secondary	Health care resource utilization	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).	Up to 4 weeks