Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive digital health coaching program

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Other

Receive standard of care support services

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. Change in Cancer Behavior Inventory (CBI) score

    Time frame: Baseline to 3 months

    The Cancer Behavior Inventory (CBI) is 27-item instrument that measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 7-point response scale ranging from 1 "Not at all confident" to 7 "Confident" (higher score equals greater efficacy for coping).

    • Minimum Score-27, max- 189
    • Will be calculated along with 95% confidence intervals.

Secondary outcomes

  1. Physiologic and psychosocial outcomes

    Time frame: Up to 3 months

    Linear mixed models (LMMs) will be created to assess the correlation between self-efficacy, using the Cancer behavior inventory (CBI), and physiologic and psychosocial outcomes (as measured by the Functional Assessment of Cancer Therapy-Leukemia Questionnaire).

    The Functional Assessment of Cancer Therapy with Leukemia Questionnaire (FACT-Leu) is a 44-item measure of quality of life associated with leukemia treatment. It consists of 4 defined domains: physical, social, emotional, and functional, as well as 17 items related to additional disease and treatment related concerns. Responses are measured on a five-point scale ranging from 0 (not at all) to 4 (very much).

    • Minimum Score -0, Maximum Score - 176

  2. Symptom experience

    Time frame: Up to 3 months

    Linear mixed models will be created to assess the correlation between self-efficacy (CBI) and symptom experience (as measured by the MD Anderson Symptom Inventory).

    The MD Anderson Symptom Inventory (MDASI) is a multiple-symptom measure of the severity of cancer-related symptoms and the functional interference caused by symptoms that is sensitive to disease and treatment changes. Patients rate the severity of 13 physical, affective, and cognitive symptoms on 0-10 numeric scales, ranging from "not present" to "as bad as you can imagine." The MDASI also assesses 6 items related to symptom interference with functioning, also a 0-10 numeric scale ranging from "did not interfere" to "interfere completely." The MDASI takes less than five minutes to complete.

    • Minimum Score - 0, Maximum Score - 190

  3. Perceived financial toxicity

    Time frame: Up to 3 months

    LMMs will be created to assess the correlation between self-efficacy (CBI) and perceived financial toxicity (as measured by the Comprehensive Score for Financial Toxicity).

    Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL. The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

    • Minimum Score - 12, Maximum Score - 28

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.