Acute Myeloid LeukemiaNCT02226497
Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy
A study testing Health Telemonitoring, Quality-of-Life Assessment and Questionnaire Administration in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Health Telemonitoring, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2015to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- Health Telemonitoring, Quality-of-Life Assessment, Questionnaire Administration, Supportive Care
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health TelemonitoringDevice
Use home telemonitoring device
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive standard outpatient supportive care
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard outpatient supportive care) | Active comparator | Patients receive standard outpatient supportive care after completion of chemotherapy. Receives: 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). Receives: Device: Health Telemonitoring; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 4 weeks
Secondary outcomes (7)
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.
Measured: Up to 4 weeks
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.
Measured: Up to 4 weeks (at end of study period)
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.
Measured: 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
Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL.
Measured: Up to 4 weeks (at end of study period)
Percentage of returned surveys
Percentage of returned surveys will be measured as a feasibility outcome.
Measured: Up to 4 weeks
Mortality
The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.
Measured: Up to 4 weeks
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).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study start9 Jan 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Halpern, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226497
- Sponsor's protocol ID
- 9105
- Other IDs
- NCI-2014-01680, FHCRC #9105, 9105, P30CA015704
- Status last verified
- Jan 2020
- First submitted
- 21 Aug 2014
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02226497
- Acronym / sponsor ID
- 9105
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient staff
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jan 2015 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard outpatient supportive care) | Active comparator | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Supportive CarePatients receive standard outpatient supportive care after completion of chemotherapy. |
| Arm II (home telemonitoring device) | Experimental | Device: Health Telemonitoring, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Supportive CarePatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health TelemonitoringUse home telemonitoring device | Device | Arm II (home telemonitoring device) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (standard outpatient supportive care), Arm II (home telemonitoring device) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard outpatient supportive care), Arm II (home telemonitoring device) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive standard outpatient supportive care | Procedure or surgery | Arm I (standard outpatient supportive care), Arm II (home telemonitoring device) |
Primary outcome
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.
7 secondary outcomes
Changes in patient conditions
Time frame: Up to 4 weeks
Degree of satisfaction of the patients/caregivers with the telemonitoring intervention
Time frame: Up to 4 weeks (at end of study period)
Degree of satisfaction of health care professionals with the telemonitoring intervention
Time frame: 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
Time frame: Up to 4 weeks (at end of study period)
Percentage of returned surveys
Time frame: Up to 4 weeks
Mortality
Time frame: Up to 4 weeks
Health care resource utilization
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Halpern principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Telemonitoring, Quality-of-Life Assessment and Questionnaire Administration in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients willing to use the in-home telemonitoring device (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.