Effect of Digital Health Coaching Program on Self-efficacy and Patient Reported Outcomes of Patients With Newly Diagnosed Acute Myeloid Leukemia or Chronic Lymphocytic Leukemia
NCT ID: NCT04774744
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2020-03-17
2023-09-13
Brief Summary
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Detailed Description
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I. To evaluate the effect of digital health coaching on self-efficacy among two cohorts of individuals with acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), respectively, as measured by the Cancer Behavior Inventory (CBI version \[v.\] 3).
SECONDARY OBJECTIVES:
I. To evaluate the relationship between self-efficacy and patient reported outcomes among individuals with and without digital health coaching, specifically:
Ia. The physiologic and psychosocial outcomes of individuals with AML and CLL as measured by the Functional Assessment of Cancer Therapy-Leukemia Questionnaire (FACT-Leu).
Ib. The symptom experience of individuals with AML and CLL as measured by the MD Anderson Symptom Inventory (MDASI).
Ic. The financial toxicity of individuals with AML and CLL as measured by the Comprehensive Score for Financial Toxicity (COST).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive the PACK Health digital health coaching program over 3 months consisting of communication initiated by either the PACK Health coach or the patient through either text, e-mail, or phone call, to provide education and support related to a specific topic such as fatigue, nutrition, or exercise.
GROUP II: Patients receive standard of care support services consisting of a telephone triage line that patients may call when experiencing physical or psychological concerns, or with any other questions related to their disease or treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (digital health coaching program)
Patients receive the PACK Health digital health coaching program over 3 months consisting of communication initiated by either the PACK Health coach or the patient through either text, e-mail, or phone call, to provide education and support related to a specific topic such as fatigue, nutrition, or exercise.
Educational Intervention
Receive digital health coaching program
Questionnaire Administration
Ancillary studies
Group II (standard of care support services)
Patients receive standard of care support services consisting of a telephone triage line that patients may call when experiencing physical or psychological concerns, or with any other questions related to their disease or treatment.
Questionnaire Administration
Ancillary studies
Supportive Care
Receive standard of care support services
Interventions
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Educational Intervention
Receive digital health coaching program
Questionnaire Administration
Ancillary studies
Supportive Care
Receive standard of care support services
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals newly diagnosed with either acute myelogenous (AML) or chronic lymphocytic leukemia (CLL), defined as within three months of diagnosis
* Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments
* Individuals with a prior history of myelodysplastic syndrome (MDS) will be allowed to enroll
Exclusion Criteria
* Individuals who have undergone treatment for previous diagnoses of leukemia
* Individuals for whom there is documentation of inability to provide consent in the medical record
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Courtney DiNardo
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2020-07406
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0806
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0806
Identifier Type: -
Identifier Source: org_study_id
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