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

NCT04774744 | Completed

• 2 other identifiers: 2018-0806NCI-2020-07406
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Change in Cancer Behavior Inventory (CBI) score

  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.

  Baseline to 3 months

Secondary Outcomes (3)

• Physiologic and psychosocial outcomes

  Up to 3 months

• Symptom experience

  Up to 3 months

• Perceived financial toxicity

  Up to 3 months

Study Arms (2)

Group I (digital health coaching program)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Questionnaire Administration

Group II (standard of care support services)

ACTIVE COMPARATOR

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.

Other: Questionnaire Administration; Other: Supportive Care

Interventions

Educational Intervention OTHER

Receive digital health coaching program

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (digital health coaching program)

Questionnaire Administration OTHER

Ancillary studies

Group I (digital health coaching program); Group II (standard of care support services)

Supportive Care OTHER

Receive standard of care support services

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Group II (standard of care support services)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Early Intervention, Educational; Educational Status; Methods; Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient Care; Therapeutics

Study Officials

• Courtney DiNardo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: March 1, 2021
• Study Start: March 17, 2020
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

US (1)