Clinical trial 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
Official title: Evaluating the Effect of a Digital Coaching Program on Self-Efficacy and Patient Reported Outcomes of Individuals With Acute and Chronic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Able to read, speak and consent in English
* 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 are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
* 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

Primary outcomes:
measure: Change in Cancer Behavior Inventory (CBI) score
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Physiologic and psychosocial outcomes
timeFrame: Up to 3 months
measure: Symptom experience
timeFrame: Up to 3 months
measure: Perceived financial toxicity
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Courtney DiNardo
role: PRINCIPAL_INVESTIGATOR
References: