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

NCT02226497 | Terminated

• 4 other identifiers: 9105NCI-2014-01680FHCRC #9105P30CA015704
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Changes in patient conditions

  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)

• 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

Study Arms (2)

Arm I (standard outpatient supportive care)

ACTIVE COMPARATOR

Patients receive standard outpatient supportive care after completion of chemotherapy.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care

Arm II (home telemonitoring device)

EXPERIMENTAL

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).

Device: Health Telemonitoring; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care

Interventions

Health Telemonitoring DEVICE

Use home telemonitoring device

Arm II (home telemonitoring device)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (standard outpatient supportive care); Arm II (home telemonitoring device)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard outpatient supportive care); Arm II (home telemonitoring device)

Supportive Care PROCEDURE

Receive standard outpatient supportive care

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm I (standard outpatient supportive care); Arm II (home telemonitoring device)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anna Halpern

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 27, 2014
• Study Start: January 9, 2015
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

US (1)