NCT04774744

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

Evaluating the Effect of a Digital Coaching Program on Self-Efficacy and Patient Reported Outcomes of Individuals With Acute and Chronic Leukemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the effect of a digital health coaching program on self-efficacy and patient reported outcomes of patients with acute myeloid leukemia or chronic lymphocytic leukemia that is newly diagnosed. A digital health coaching program may help leukemia patients report information about their health while receiving treatment, which may lead to improvement in overall health.

Detailed description

PRIMARY OBJECTIVE: 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

• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
OTHER	Educational Intervention	Receive digital health coaching program
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Supportive Care	Receive standard of care support services

Timeline

• Start date: 2020-03-17
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2021-03-01
• Last updated: 2023-09-18

Locations

1 site across 1 country: United States