Barriers and facilitators to taking CDK4/6 inhibitors among patients with metastatic breast cancer: a qualitative study.

PURPOSE: Most studies of adherence to treatment for breast cancer have focused on early-stage patients. Findings from these studies may not generalize to patients with metastatic breast cancer (MBC). The objective of this study was to identify barriers and facilitators of adherence to cyclin-dependent kinase 4/6 (CDK4/6) inhibitors among patients with MBC, guided by the social ecologic model (SEM). METHODS: Patients with MBC (N = 25), their caregivers (N = 9), and oncology providers (N = 13) completed semi-structured qualitative interviews exploring their experiences with CDK4/6 inhibitors. Interviews were audio-recorded, transcribed verbatim, and analyzed by three raters using a combined deductive and inductive approach. RESULTS: Qualitative analysis identified barriers and facilitators of adherence at each SEM level. Intrapersonal and interpersonal factors were most frequently discussed. Intrapersonal factors included knowledge/beliefs about CDK4/6 inhibitors, side effects, and establishing a routine. Interpersonal factors included effective communication with/coordination by the care team, support from family and friends, and information from other patients with MBC. Although less frequently discussed, policy factors (i.e., cost of CDK4/6 inhibitors) were of great concern to patients, caregivers, and providers. CONCLUSION: Barriers to adherence to CDK4/6 inhibitors exist at multiple levels. Our results underscore the potential value of a multilevel intervention (e.g., patient education, evidence-based strategies for symptom management, tips for open and assertive communication with providers, information about financial resources/support available, and so on) to support adherence in this population.

More often than not, we're in sync: patient and caregiver well-being over time in stem cell transplantation.

BACKGROUND: Hematopoietic stem cell transplantation (HSCT) is an aggressive medical procedure which significantly impacts the shared emotional well-being of patients and family caregivers (FC). Prior work has highlighted the significant overlap in well-being among patients and FCs; however, how this interdependence may change over the course of HSCT has received less attention. METHODS: We conducted secondary analyses of a supportive intervention delivered to 154 FCs of HSCT patients and examined relationships at baseline, 6 weeks, 3 and 6 months post-HSCT. Actor Partner Interdependence Modeling examined patient quality of life (QOL) and FC anxiety/depression. RESULTS: The data did not fit a multigroup approach limiting our ability to test intervention effects; however, bivariate analyses indicated FC depression significantly correlated to patient QOL at baseline (r = - .32), 6 weeks (r = - .22) and 6 months post-HSCT (r = - .34; p's < .05); whereas FC anxiety was only correlated with patient QOL at the first two timepoints (p's < .05). There was an unexpected, partner effect such that worse patient QOL at 6-weeks significantly related to lower FC depression at 3-months (B = .193; p = .026) and changed direction with patient QOL at 3-months being related to more FC depression at 6-months (B = - .187; p = .001). CONCLUSIONS: These findings highlight the significant, yet nuanced, interdependence of patient QOL and FC well-being during HSCT. Specifically, greater interdependence was observed between patient QOL and FC depression compared to FC anxiety, suggesting potential treatment targets for patients and their families. Trial was registered at ClinicalTrials.gov Identifier: NCT02037568; first registered: January 16, 2014; https://clinicaltrials.gov/ct2/show/NCT02037568.

A pilot study of mobilized intervention to help caregivers of oncology patients manage distress.

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.

Randomized Trial of a Smartphone Mobile App to Improve Symptoms and Adherence to Oral Therapy for Cancer.

BACKGROUND: Patients with cancer are increasingly prescribed oral therapies, bearing greater responsibility for self-management of treatment adherence and adverse events. We conducted a randomized trial to test the use of a smartphone mobile app to improve symptoms and adherence to oral cancer therapy. MATERIALS AND METHODS: From February 18, 2015, through December 31, 2016, 181 patients with diverse cancers who were prescribed oral therapy were randomized to receive either the smartphone mobile app or standard care. The mobile app included a medication plan with reminders, a symptom-reporting module, and patient education. Primary outcomes were adherence (per electronic pill caps), symptom burden (per MD Anderson Symptom Inventory), and quality of life (per the Functional Assessment of Cancer Therapy-General). Participants also completed self-report measures of medication adherence, anxiety and depression symptoms, social support, quality of care, and healthcare utilization. Linear regression was used to assess intervention effects on adherence and change in self-report outcomes from baseline to week 12, controlling for baseline scores and social support. RESULTS: Study groups did not differ across any outcome measure, with an overall mean adherence of 78.81% (SD, 26.66%) per electronic pill caps. However, moderation analyses showed that intervention effects on the primary adherence measure varied by baseline self-reported adherence and anxiety symptoms. Specifically, adherence rates per electronic pill caps were higher in patients randomized to the mobile app versus standard care within the subsamples of patients who reported baseline adherence problems (mean difference, -22.30%; 95% CI, -42.82 to -1.78; P=.034) and elevated anxiety (mean difference, -16.08%; 95% CI, -31.74 to -0.41; P=.044). CONCLUSIONS: Although the mobile app may not improve outcomes for all patients prescribed oral cancer therapy, the intervention may be beneficial for those with certain risk factors, such as difficulties with adherence or anxiety.

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.

Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life.

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 cancer-related 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 (r= -0.20). 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]=50.53; adjusted R2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (ß= -7.10; SE=0.22). 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.

Pilot study of a multimodal intervention to enhance sexual function in survivors of hematopoietic stem cell transplantation.

BACKGROUND: Although sexual dysfunction is common after hematopoietic stem cell transplantation (HCT), interventions to address sexual function are lacking. METHODS: We conducted a pilot study to assess the feasibility and preliminary efficacy of a multimodal intervention to address sexual dysfunction in allogeneic HCT survivors. Transplant clinicians screened HCT survivors ≥3 months post-HCT for sexual dysfunction causing distress. Those who screened positive attended monthly visits with a trained transplant clinician who: 1) performed an assessment of the causes of sexual dysfunction; 2) educated and empowered the patient to address his or her sexual concerns; and 3) implemented therapeutic interventions targeting the patient's needs. Feasibility was defined as having approximately 75% of patients who screened positive agreeing to participate and 80% attending at least 2 intervention visits. We administered the Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function and satisfaction measure, the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), and the Hospital Anxiety and Depression Scale (HADS) to evaluate sexual function, quality of life (QOL), and mood, respectively, at baseline and 6 months postintervention. RESULTS: Approximately 33.1% of patients (50 of 151 patients) screened positive for sexual dysfunction causing distress and 94.0% (47 of 50 patients) agreed to participate, with 100% attending 2 intervention visits. Participants reported improvements in satisfaction (P<.0001) and interest in sex (P<.0001), as well as orgasm (P<.0001), erectile function (P<.0001), vaginal lubrication (P = .0001), and vaginal discomfort (P = .0005). At baseline, approximately 32.6% of participants were not sexually active, compared with 6.5% after the intervention (P = .0005). Participants reported improvement in their QOL (P<.0001), depression (P = .0002), and anxiety (P = .0019). CONCLUSIONS: A multimodal intervention to address sexual dysfunction integrated within the transplant clinic is feasible with encouraging preliminary efficacy for improving sexual function, QOL, and mood in HCT survivors. Cancer 2018;124:2438-46. © 2018 American Cancer Society.

Design and Development of a Multimodal Digital Intervention (SHIFT App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant (HSCT) Survivors.

Hematopoietic stem cell transplant (HSCT) survivors frequently experience persistent sexual dysfunction, which is associated with impaired quality of life and increased psychological distress. The lack of availability of clinicians with expertise in sexual health limits the capacity to address sexual health concerns in HSCT survivors. Digital health applications may offer a patient-centered and scalable solution to address sexual health concerns in cancer survivors. The objective of this report is to delineate the iterative process of adapting an in-person sexual health intervention into a self-administered digital application called "Sexual Health and Intimacy Following Transplant (SHIFT)" and the refinement of SHIFT using stakeholder feedback. We used a five-step development model to adapt SHIFT that included: (1) implementation of a multimodal bio-psycho-social conceptual framework, (2) development of a comprehensive intervention manual and SHIFT content, (3) translation of the intervention manual into an interactive storyline with a focus on enhancing patient engagement, (4) creation of initial SHIFT wireframes, and (5) refinement of SHIFT through iterative alpha and beta testing. At each step, key stakeholders including HSCT survivors, HSCT clinicians, and experts in sexual health, psychology, and digital health provided iterative feedback. We adapted SHIFT based on our conceptual framework, prior in-person intervention work, and iterative stakeholder feedback in each application development stage. SHIFT incorporates medical information, educational materials, intimacy exercises, and activities to address the multiple etiologies of sexual health concerns in HSCT survivors. SHIFT includes strategies to enhance engagement including gamification, personalization, and incorporation of video from HSCT survivors and clinicians. Based on stakeholder feedback, SHIFT was refined with a focus on inclusivity of gender, sexual orientation, relationship status, and body image concerns. SHIFT is novel, patient-centered digital application to address sexual dysfunction in HSCT survivors. Iterative feedback from key stakeholders including HSCT survivors guided SHIFT adaptation and refinement, to optimize patient engagement and ensure inclusivity. The final prototype of SHIFT was initially acceptable to key stakeholders and is now under further testing in a pilot randomized trial to assess its feasibility and preliminary efficacy for improving sexual health outcomes in HSCT survivors.

Impact of a Mobilized Stress Management Program (Pep-Pal) for Caregivers of Oncology Patients: Mixed-Methods Study.

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).

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups

BACKGROUND: Caregivers 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). OBJECTIVE: The 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. METHODS: We 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). RESULTS: Overall, 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. CONCLUSIONS: Feedback 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.

Correction of: Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups.

[This corrects the article DOI: 10.2196/resprot.7075.].

Treatment Satisfaction and Adherence to Oral Chemotherapy in Patients With Cancer.

PURPOSE: Although patients with cancer overwhelming prefer oral to intravenous chemotherapy, little is known about adherence to oral agents. We aimed to identify the rates and correlates of adherence in patients with diverse malignancies. MATERIALS AND METHODS: Ninety patients with chronic myeloid leukemia or metastatic renal cell carcinoma, non-small-cell lung cancer, or breast cancer enrolled in this prospective, single-group, observational study of medication-taking behaviors. Adherence was measured via self-report and with an electronic pill cap (Medication Event Monitoring System cap). Patients completed surveys regarding symptom distress, mood, quality of life, cancer-specific distress, and satisfaction with clinician communication and treatment at baseline and 12-week follow-up. RESULTS: As measured by the Medication Event Monitoring System, patients took, on average, 89.3% of their prescribed oral chemotherapy over the 12 weeks. One quarter of the sample was less than 90% adherent, and women were more adherent than men (mean difference, 9.59%; SE difference, 4.50%; 95% CI, -18.65 to -0.52; P = .039). Improvements in patient symptom distress (B = -0.79; 95% CI, -1.41 to -0.18), depressive symptoms (B = -1.57; 95% CI, -2.86 to -0.29), quality of life (B = 0.38; 95% CI ,0.07 to 0.68), satisfaction with clinician communication and treatment (B = 0.73; 95% CI, 0.49 to 0.98), and perceived burden to others (B = -1.28; 95% CI, -2.20 to -0.37) were associated with better adherence. In a multivariate model, improved treatment satisfaction (B = 0.71; 95% CI, 0.48 to 0.94) and reduced perceived burden (B = -0.92; 95% CI, -1.76 to -0.09) were the strongest indicators of better adherence. CONCLUSION: 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.

Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development.

BACKGROUND: Oral 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. OBJECTIVE: The 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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: To 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. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management. TRIAL REGISTRATION: ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA).