Effect of Digital Health Coaching on Self-Efficacy and Patient-Reported Outcomes in Individuals with Acute Myeloid and Chronic Lymphocytic Leukemia: A Pilot Randomized Controlled Trial

Abstract

Introduction: Promotion of self-efficacy can enhance engagement with health care and treatment adherence in patients with cancer. We report the outcomes of a pilot trial of a digital health coach intervention in patients with leukemia with the aim of improving self-efficacy.

Methods: Adult patients with newly diagnosed acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL) were randomized 1:1 to a digital health coach intervention or standard of care. The primary outcome of self-efficacy was measured by the Cancer Behavior Inventory (CBI) score.

Results: A total of 147 patients (37 AML, 110 CLL) were enrolled from July 2020 to December 2022. In the AML cohort, there was a mean increase in CBI score of 7.03 in the digital health coaching arm compared to a mean decrease of -3.57 in the control arm at 30 days (p = 0.219). There were no significant associations between the intervention and other patient-reported outcomes for patients with CLL.

Conclusion: There were numerical, but not statistically significant increases in self-efficacy metrics in AML patients who received digital health coaching. Although this trial was underpowered due to enrollment limitations during a pandemic, digital health coaching may provide benefit to patients with hematologic malignancy and warrants further investigation.

Introduction: Promotion of self-efficacy can enhance engagement with health care and treatment adherence in patients with cancer. We report the outcomes of a pilot trial of a digital health coach intervention in patients with leukemia with the aim of improving self-efficacy.

Methods: Adult patients with newly diagnosed acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL) were randomized 1:1 to a digital health coach intervention or standard of care. The primary outcome of self-efficacy was measured by the Cancer Behavior Inventory (CBI) score.

Results: A total of 147 patients (37 AML, 110 CLL) were enrolled from July 2020 to December 2022. In the AML cohort, there was a mean increase in CBI score of 7.03 in the digital health coaching arm compared to a mean decrease of -3.57 in the control arm at 30 days (p = 0.219). There were no significant associations between the intervention and other patient-reported outcomes for patients with CLL.

Conclusion: There were numerical, but not statistically significant increases in self-efficacy metrics in AML patients who received digital health coaching. Although this trial was underpowered due to enrollment limitations during a pandemic, digital health coaching may provide benefit to patients with hematologic malignancy and warrants further investigation.

Keywords: Acute myeloid leukemia; Chronic lymphocytic leukemia; Clinical trial; Digital health coach; Self-efficacy.

Fig. 1.

CONSORT Diagram. A total of 823 patients met the trial’s strict inclusion and exclusion criteria. Out of these, 305 patients were interested in receiving the informed consent. A total of 157 participants signed consent, 10 of which did not complete the baseline surveys and therefore were removed from the study. Ultimately, 37 patients with AML and 110 patients with CLL were independently randomized to the control or digital health coach intervention arms. Twenty-six of the 37 patients with AML did not complete the final study instruments at the completion of the study on day 90. Twenty-nine of the 110 patients with CLL did not complete the final study instruments.

Fig. 2.

Box plots of mean change in CBI scores at 30 days in the AML cohort. The CBI is a validated 27-item instrument filled out by patients that measures self-efficacy in coping with cancer across seven major domains using a 7-point response scale ranging from 1 “Not confident at all” to 7 “Confident.” Higher scores indicate higher self-efficacy. CBI scores were measured at baseline and at 30 days post-intervention. Box and whisker plots were constructed to show a mean change in CBI score in both the intervention and control groups. a demonstrates a change in total CBI score, whereas b demonstrates the change in each individual domain of CBI score in patients with AML. The control group is shown in black (n = 14) and the digital health coach intervention group (n = 10) in blue. Dots indicated outliers.

Fig. 3.

Box plots of mean change in CBI scores at 30 days in the CLL cohort. The CBI is a validated 27-item instrument filled out by patients that measures self-efficacy in coping with cancer across seven major domains using a 7-point response scale ranging from 1 “Not confident at all” to 7 “Confident.” Higher scores indicate higher self-efficacy. CBI scores were measured at baseline and at 30 days post-intervention. Box and whisker plots were constructed to show a mean change in CBI score in both the intervention and control groups. a demonstrates a change in total CBI score, whereas b demonstrates the change in each individual domain of CBI score in patients with AML. The control group is shown in black (n = 48) and the digital health coach intervention group (n = 44) in blue. Dots indicated outliers.