Randomized trial of a smartphone mobile app for adherence to oral chemotherapy

10055 Background: As patients with cancer are increasingly prescribed oral chemotherapy, they share greater responsibility for ensuring adherence and monitoring side effects. The aim of this study was to test the effect of a smartphone mobile app to improve adherence and symptom management in patients prescribed oral chemotherapy. Methods: From 2/15 to 12/16, 181 patients with diverse cancers prescribed oral chemotherapy were randomized to receive either the smartphone mobile app or standard care. The mobile app included a medication treatment plan with alerts, symptom reporting module, education library, and cancer-specific resources. The primary outcome was adherence, measured by electronic pill cap (MEMS) and self-report (Morisky Medication Adherence Scale; MMAS). To assess symptoms, mood, and satisfaction with care, participants completed the MD Anderson Symptom Inventory, Hospital Anxiety & Depression Scale (HADS); and Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction (FACIT-TS) at baseline and 12 weeks. General linear models were used to assess intervention effects on patient outcomes. Results: Study groups did not differ across outcome measures from baseline to week 12. Secondary analyses showed that baseline adherence (MMAS) and anxiety (HADS) were moderators of intervention effects on adherence and treatment satisfaction. Among patients who reported adherence problems, those assigned to the mobile app had better average MEMS adherence (Mean Diff = 19.30, 95% CI = 0.09-38.51, p = .05) and satisfaction with clinician explanations per the FACIT-TS (Mean Diff = 1.69, 95% CI = 0.25-3.13, p = .02) compared to standard care. Also, among patients with higher anxiety, those in the mobile app group reported better adherence on the 12-week MMAS (95.2% vs. 68.0%, OR = 0.11, 95% CI = 0.01, 0.94, p = .04) and satisfaction with interpersonal treatment per the FACIT-TS (Mean Diff = 0.76, 95% CI = 0.13-1.39, p = .02) compared to standard care. Conclusions: Although potentially not for everyone taking oral chemotherapy, a smartphone mobile app to improve adherence and treatment satisfaction may be useful for patients with certain risk factors, such as those struggling with adherence or anxiety. Clinical trial information: NCT02157519

Randomized trial of a cognitive-behavioral therapy mobile app for anxiety in patients with incurable cancer

10022 Background: Patients with incurable cancer often experience marked anxiety that is associated with poor quality of life (QOL), high symptom burden, and complications with medical treatment. The aim of this study was to test the efficacy of a mobile app-based cognitive-behavioral therapy (CBT) intervention to treat anxiety symptoms in patients with incurable cancer. Methods: From 2/15 to 8/16, 145 patients with incurable cancers (e.g., advanced lung, breast, GI/GU, sarcoma, melanoma) who screened positive for at least mild anxiety symptoms (Hospital Anxiety & Depression Scale-Anxiety subscale, HADS-A > 7) were randomized 1:1 at two cancer centers to receive either the CBT mobile app for anxiety or a mobile health education program (control), delivered via tablet computers. The CBT app included 7 modules teaching skills to relax the body, reduce worry, stay present-focused, improve communication, and plan/pace activities, which patients completed over 12 weeks. To assess anxiety, mood, and QOL, we administered the Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), HADS, and Functional Assessment of Cancer Therapy-General at baseline and 12 weeks. General linear models were used to assess the effect of the intervention on patient outcomes over time. Results: The sample was predominantly female (73.8%) and white (91.7%), with a mean age of 56.45 ( SD= 11.30) years. Both study groups reported significant improvements in anxiety, depression, and QOL from baseline to post-assessment (all p-values≤002), with no differences in the improved outcomes between groups. Secondary analyses showed interaction effects on anxiety between the intervention and baseline HAM-A scores. Among patients with higher baseline anxiety, those randomized to the CBT app had greater improvements on the HAM-A ( p= .043), CGI ( p= .048), and HADS-A ( p= .001) compared to the health education control group. Conclusions: Patients with incurable cancer who received either a CBT mobile app intervention or mobile health education program reported improvements in anxiety, depression, and QOL. However, the CBT mobile app had better outcomes than health education for patients with higher baseline anxiety. Clinical trial information: NCT02286466

Randomized trial of a cognitive-behavioral therapy mobile app for anxiety in patients with incurable cancer

175 Background: Patients with incurable cancer often experience marked anxiety that is associated with poor quality of life (QOL), high symptom burden, and complications with medical treatment. The aim of this study was to test the efficacy of a mobile app-based cognitive-behavioral therapy (CBT) intervention to treat anxiety symptoms in patients with incurable cancer. Methods: From 2/15 to 8/16, 145 patients with incurable cancers (e.g., advanced lung, breast, GI/GU, sarcoma, melanoma) who screened positive for at least mild anxiety symptoms (Hospital Anxiety & Depression Scale-Anxiety subscale, HADS-A > 7) were randomized 1:1 at two cancer centers to receive either the CBT mobile app for anxiety or a mobile health education program (control), delivered via tablet computers. The CBT app consisted of 7 modules teaching skills to relax the body, reduce worry, stay present-focused, improve communication, and plan/pace activities, which patients completed over 12 weeks. To assess anxiety, mood, and QOL, we administered the Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), HADS, and Functional Assessment of Cancer Therapy-General at baseline and 12 weeks. General linear models were used to assess the effect of the intervention on patient outcomes over time. Results: The sample was predominantly female (73.8%) and white (91.7%), with a mean age of 56.45 ( SD= 11.30) years. Both study groups reported significant improvements in anxiety, depression, and QOL from baseline to post-assessment (all p-values < .002), with no differences in the improved outcomes between groups. Secondary analyses revealed interaction effects on anxiety between the intervention and baseline HAM-A scores. Among patients with higher baseline anxiety, those randomized to the CBT app had greater improvements on the HAM-A ( p= .043), CGI ( p= .048), and HADS-A ( p= .001) compared to the health education control group. Conclusions: Patients with incurable cancer who received either a CBT mobile app intervention or mobile health education program reported improvements in anxiety, depression, and QOL. However, the CBT mobile app had better outcomes than health education for patients with higher baseline anxiety. Clinical trial information: NCT02286466

Randomized trial of a smartphone mobile app for adherence to oral chemotherapy

230 Background: As patients with cancer are increasingly prescribed oral chemotherapy, they share greater responsibility for ensuring adherence and monitoring side effects. The aim of this study was to test the effect of a smartphone mobile app to improve adherence and symptom management in patients prescribed oral chemotherapy. Methods: From 2/15 to 12/16, 181 patients with diverse cancers prescribed oral chemotherapy at an urban cancer center were randomized to receive either the smartphone mobile app or standard care. The mobile app included a medication treatment plan with alerts, symptom reporting module, education library, and cancer-specific resources. The primary outcome was adherence, measured by electronic pill cap (MEMS) and self-report (Morisky Medication Adherence Scale; MMAS). To assess symptoms, mood, and quality of life, participants completed the MD Anderson Symptom Inventory, Hospital Anxiety & Depression Scale (HADS); and Functional Assessment of Cancer Therapy-General (FACT-G) at baseline and 12 weeks. General linear models were used to assess intervention effects on patient outcomes. Results: Study groups did not differ across outcome measures from baseline to week 12, except patients in the mobile app group had less of a reduction in social well-being (FACT-G) over time (Mean Diff = 1.67, 95% CI = -3.12, -0.21, p = .025). Secondary analyses showed that baseline adherence (MMAS) and anxiety (HADS) were moderators of intervention effects on self-reported and electronically monitored adherence. Among patients who reported adherence problems, those assigned to the mobile app had better average MEMS adherence (Mean Diff = -22.30, 95% CI = -42.82, -1.78, p = .034) compared to standard care. Similarly, among patients with higher baseline anxiety, those in the mobile app group had better average MEMS adherence (Mean Diff = -16.08, 95% CI = -31.74, -0.41, p = .044) and reported fewer adherence problems on the MMAS at 12 weeks (4.3% vs 32%, OR = 0.06, 95% CI = 0.003, 0.96, p = .047) compared to standard care. Conclusions: A patient-centered, smartphone mobile app designed to improve adherence to oral chemotherapy may be especially useful for patients with certain risk factors, such as those struggling with adherence or anxiety. Clinical trial information: NCT02157519

Randomized Trial of a Tailored Cognitive‐Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer

Background The aim of this study was to test the efficacy of a tailored cognitive‐behavioral therapy (CBT) mobile application (app) to treat anxiety in patients with incurable cancer. Materials and Methods Patients with incurable cancers (n = 145) who reported elevated anxiety symptoms at two cancer centers were randomized to receive either the CBT mobile app for anxiety or a mobile health education program (control) delivered via tablet computers, which patients self‐administered over 12 weeks. To assess anxiety, depression symptoms, and quality of life (QOL), we used the Hamilton Anxiety Rating Scale (HAM‐A, primary outcome), Clinical Global Impression Scale, Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire‐9, and Functional Assessment of Cancer Therapy‐General at baseline and 12 weeks. Analysis of covariance models were calculated to assess intervention effects on patient outcomes. Results Patients (73.8% female; 91.0% white; mean age = 56.45 years, SD = 11.30) in both study groups reported improvements in anxiety, depression symptoms, and QOL from baseline to postassessment, with no significant differences in any outcome measure between groups. Secondary analyses showed that, among the subgroup of patients with severe baseline anxiety, those randomized to the CBT app had greater improvements on the HAM‐A (Mean Difference = 7.44, standard error [SE] = 3.35, p = .037) and HADS‐Anxiety Subscale (Mean Difference = 4.44, SE = 1.60, p = .010) compared with the control group. Conclusion Both the tailored CBT app for anxiety and the health education program were associated with improvements in anxiety, mood, and QOL, but these outcomes did not differ between study groups. The CBT app was more beneficial than health education for patients with severe baseline anxiety. Implications for Practice A cognitive‐behavioral therapy mobile application tailored to treat anxiety in patients with advanced cancer helps improve access to evidence‐based supportive care in a convenient, private, and timely manner. Many patients with advanced cancer report clinically significant anxiety symptoms. Cognitive behavioral therapy (CBT) is a treatment for anxiety that has been shown to be successful. This study tested the efficacy of a CBT intervention that was adapted to a mobile application that could be self‐administered, comparing its use to the use of a health education program administered similarly