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
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|ClinicalTrials.gov Identifier: NCT04774744|
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : September 23, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Chronic Lymphocytic Leukemia||Other: Educational Intervention Other: Questionnaire Administration Other: Supportive Care||Not Applicable|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating the Effect of a Digital Coaching Program on Self-Efficacy and Patient Reported Outcomes of Individuals With Acute and Chronic Leukemia|
|Actual Study Start Date :||March 17, 2020|
|Estimated Primary Completion Date :||July 30, 2023|
|Estimated Study Completion Date :||July 30, 2023|
Experimental: 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.
Other: Educational Intervention
Receive digital health coaching program
Other: Questionnaire Administration
Active Comparator: 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.
Other: Questionnaire Administration
Other: Supportive Care
Receive standard of care support services
- 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.
- 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
- 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
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774744
|Contact: Courtney DiNardofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Courtney DiNardo 713-794-1141|
|Principal Investigator: Courtney DiNardo|
|Principal Investigator:||Courtney DiNardo||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2020-07406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0806 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||March 1, 2021 Key Record Dates|
|Last Update Posted:||September 23, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases