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.

BackgroundOral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management.ObjectiveThe objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer.MethodsWe used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial.ResultsWe incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps.ConclusionsTo our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Fo...

Women and patients who reported increased treatment satisfaction and reduced burden to others were more adherent to oral chemotherapy. Interventions that help patients improve communication with clinicians and reduce burden may optimize oral chemotherapy adherence.

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.

Background: Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL). Materials and Methods: From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression. Results: At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancerrelated symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r5 20.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F [10, 146]550.53; adjusted R 2 50.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (b5 27.10; SE50.22). Conclusions: Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.

Objective Caregivers of patients with advanced cancer experience significant anxiety, depression, and distress. Caregivers have barriers to accessing in‐person treatment to manage stress. Technology allows for the dissemination of evidence‐based interventions in a convenient way. This study examined usage rates of Pep‐Pal (an evidence‐based mobilized intervention to help caregivers of patients with advanced cancer manage distress) and estimates of efficacy on anxiety, depression, stress, and sexual dysfunction. Methods Fifty‐six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either Pep‐Pal (a mobilized psychoeducation and skills‐based intervention for caregivers, n = 26) or treatment as usual (TAU; n = 30). All were screened for moderate anxiety on the Hospital Anxiety and Depression Scale–Anxiety screening assessment (A ≥ 8) at baseline. Results Participants randomized to Pep‐Pal experienced greater reductions in perceived stress (PSS; F = 3.91, p = .05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU. Of Pep‐Pal participants, only 10 (38.5%) watched at least 7/9 full‐length sessions. The a priori hypothesis and criterion that participants would watch at least 75% full‐length sessions were not met. Conclusions A brief, easily disseminated mobile intervention showed poor adherence, but had limited estimates of efficacy for secondary outcomes; perceived stress, learning stress management skills, and sexual functioning (women only). Future directions are discussed.

BackgroundCaregivers of cancer patients experience significant burden and distress including depression and anxiety. We previously demonstrated the efficacy of an eight session, in-person, one-on-one stress management intervention to reduce distress in caregivers of patients receiving allogeneic hematopoietic stem cell transplants (allo-HSCT).ObjectiveThe objective of this study was to adapt and enhance the in-person caregiver stress management intervention to a mobilized website (eg, tablet, smartphone, or computer-based) for self-delivery in order to enhance dissemination to caregiver populations most in need.MethodsWe used an established approach for development of a mhealth intervention, completing the first two research and evaluation steps: Step One: Formative Research (eg, expert and stakeholder review from patients, caregivers, and palliative care experts) and Step Two: Pretesting (eg, Focus Groups and Individual Interviews with caregivers of patients with autologous HSCT (auto-HSCT). Step one included feedback elicited for a mock-up version of Pep-Pal session one from caregiver, patients and clinician stakeholders from a multidisciplinary palliative care team (N=9 caregivers and patient stakeholders and N=20 palliative care experts). Step two included two focus groups (N=6 caregivers) and individual interviews (N=9 caregivers) regarding Pep-Pal’s look and feel, content, acceptability, and potential usability/feasibility. Focus groups and individual interviews were audio-recorded. In addition, individual interviews were transcribed, and applied thematic analysis was conducted in order to gain an in-depth understanding to inform the development and refinement of the mobilized caregiver stress management intervention, Pep-Pal (PsychoEducation and skills for Patient caregivers).ResultsOverall, results were favorable. Pep-Pal was deemed acceptable for caregivers of patients receiving an auto-HSCT. The refined Pep-Pal program consisted of 9 sessions (Introduction to Stress, Stress and the Mind Body Connection, How Thoughts Can Lead to Stress, Coping with Stress, Strategies for Maintaining Energy and Stamina, Coping with Uncertainty, Managing Changing Relationships and Communicating Needs, Getting the Support You Need, and Improving Intimacy) delivered via video instruction through a mobilized website.ConclusionsFeedback from stakeholder groups, focus groups, and individual interviews provided valuable feedback in key areas that was integrated into the development of Pep-Pal with the goal of enhancing dissemination, engagement, acceptability, and usability.

Background Caregivers of patients with advanced diseases are known to have high levels of distress, including depression and anxiety. Recent research has focused on recognizing caregivers in need of psychosocial support to help them manage their distress. Evidenced-based technological interventions have the potential to aid caregivers in managing distress. Objective The objective of our study was to describe caregiver perceptions of the usability and acceptability, and their suggestions for future adaptations, of a mobilized psychoeducation and skills-based intervention. Methods This study was a part of a larger trial of a mobilized psychoeducation and skills-based intervention (Psychoeducation and Skills-Based Mobilized Intervention [Pep-Pal]) for caregivers of patients with advanced illness. This substudy used a mixed-methods analysis of quantitative data from all 26 intervention participants and qualitative data from 14 intervention caregivers who completed the Pep-Pal intervention. The qualitative semistructured individual interviews, which we conducted within the first 4 weeks after participants completed the intervention, assessed the acceptability and usability of Pep-Pal. Additionally, the qualitative interviews provided contextual evidence of how the intervention was helpful to interviewees in unanticipated ways. We conducted applied thematic analysis via independent review of transcripts to extract salient themes. Results Overall, caregivers of patients with advanced cancer deemed Pep-Pal to be acceptable in all Web-based sessions except for Improving Intimacy. Caregivers perceived the program to be of use across the areas they needed and in others that they had not anticipated. Caregiver recommendations of key changes for the program were to include more variety in caregiver actors in sessions, change the title of Improving Intimacy to Improving Relationships, provide an audio-only option in addition to video, and change the format of the mobilized website program to a stand-alone mobile app. Conclusions The valuable feedback in key areas from individual interviews will be integrated into the final version of Pep-Pal that will be tested in a fully powered randomized clinical trial. Trial Registration ClinicalTrials.gov NCT03002896; https://clinicaltrials.gov/ct2/show/NCT03002896 (Archived by WebCite at http://www.webcitation.org/76eThwaei)