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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07406 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0806 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive digital health coaching program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic and psychosocial outcomes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney DiNardo | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Questionnaire Administration | Other | Ancillary studies |
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| Supportive Care | Other | Receive standard of care support services |
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| Up to 3 months |
| Symptom experience | 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 | Up to 3 months |
| Perceived financial toxicity | 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 | Up to 3 months |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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