Thresholds in PROMIS Scores Anchored to Subsequent Unscheduled Health Service Use Among People Diagnosed With Cancer.

PURPOSE: To establish thresholds in the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference, physical function, fatigue, and depression scores on the basis of their association with subsequent use of the emergency department (ED) or urgent care by people diagnosed with cancer. METHODS: Retrospective data from 952 people seen at Henry Ford Cancer and insured through the Health Alliance Plan were analyzed using generalized linear mixed-effects models. The log odds of ED or urgent care use during 14 or 30 days after each patient-reported outcome (PRO) assessment were related to PRO scores, while adjusting for comorbidity, sociodemographic, and tumor characteristics. RESULTS: Pain interference and physical function were associated with subsequent ED or urgent care visits, but fatigue and depression were not, and the results for 14- and 30-day visits were similar. Thresholds anchored in the likelihood of these visits differed according to cancer stage. For people with advanced cancer, a pain interference score of 60 or higher (odds ratio [OR] 3.75, [95% CI, 1.53 to 7.87]) and a physical function score lower than 40 (OR 2.94, [95% CI, 1.22 to 7.06]) produced the largest ORs with narrowest CIs for 30-day visits. For people with nonadvanced cancer, the thresholds of 65 for pain interference (OR 2.64, [95% CI, 1.40 to 5.01]) and 35 for physical function (OR 1.87, [95% CI, 1.01 to 3.45]) produced largest ORs with narrowest CIs for 30-day visits. CONCLUSION: These anchor-based thresholds in PROMIS scores can inform clinicians' actions with the goal of preventing ED or urgent care visits.

Effects of chronotype-tailored bright light intervention on post-treatment symptoms and quality of life in breast cancer survivors.

PURPOSE: Bright light therapy holds promise for reducing common symptoms, e.g., fatigue, experienced by individuals with cancer. This study aimed to examine the effects of a chronotype-tailored bright light intervention on sleep disturbance, fatigue, depressive mood, cognitive dysfunction, and quality of life among post-treatment breast cancer survivors. METHODS: In this two-group randomized controlled trial (NCT03304587), participants were randomized to receive 30-min daily bright blue-green light (12,000 lx) or dim red light (5 lx) either between 19:00 and 20:00 h or within 30 min of waking in the morning. Self-reported outcomes and in-lab overnight polysomnography sleep study were assessed before (pre-test) and after the 14-day light intervention (post-test). RESULTS: The sample included 30 women 1-3 years post-completion of chemotherapy and/or radiation for stage I to III breast cancer (mean age = 52.5 ± 8.4 years). There were no significant between-group differences in any of the symptoms or quality of life (all p > 0.05). However, within each group, self-reported sleep disturbance, fatigue, depressive mood, cognitive dysfunction, and quality of life-related functioning showed significant improvements over time (all p < 0.05); the extent of improvement for fatigue and depressive mood was clinically relevant. Polysomnography sleep findings showed that a number of awakenings significantly decreased (p = 0.011) among participants who received bright light, while stage 2 sleep significantly increased (p = 0.015) among participants who received dim-red light. CONCLUSION: The findings support using light therapy to manage post-treatment symptoms in breast cancer survivors. The unexpected symptom improvements among dim-red light controls remain unexplained and require further investigation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03304587, October 19, 2017.

Effects of Chronotype-tailored Bright Light Intervention on Symptoms and Quality of Life in Breast Cancer Survivors.

Purpose: Bright light therapy holds promise for reducing common symptoms, e.g., fatigue, experienced by individuals with cancer. This study aimed to examine the effects of a chronotype-tailored bright light intervention on sleep disturbance, fatigue, depressive mood, cognitive dysfunction, and quality of life among post-treatment breast cancer survivors. Methods: In this two-group randomized controlled trial (NCT03304587), participants were randomized to receive 30-min daily bright blue-green light (12,000 lux) or dim red light (5 lux) either between 19:00-20:00 h or within 30 min of waking in the morning. Self-reported outcomes and in-lab overnight polysomnography sleep study were assessed before (pre-test) and after the 14-day light intervention (post-test). Results: The sample included 30 women 1-3 years post-completion of chemotherapy and/or radiation for stage I to III breast cancer (mean age = 52.5 ± 8.4 years). There were no significant between-group differences in any of the symptoms or quality of life (all p > 0.05). However, within each group, self-reported sleep disturbance, fatigue, and depressive mood, and quality of life-related functioning showed significant improvements over time (all p < 0.01); the extent of improvement for fatigue and depressive mood was clinically relevant. Polysomnography sleep findings showed that number of awakenings significantly decreased (p = 0.011) among participants received bright light, while stage 2 sleep significantly increased (p = 0.015) among participants received dim-red light. Conclusion: The findings provide some evidence to support using chronotype-tailored light therapy to manage sleep disturbance, fatigue, depressive mood in post-treatment breast cancer survivors. The unexpected symptom improvements among dim-red light controls remain unexplained and requires further investigation. ClinicalTrialsgov Identifier: NCT03304587 Study was registered on October 19, 2017.

Patient Reported Outcomes and Unscheduled Health Services use During Oral Anti-Cancer Treatment.

CONTEXT: People on oral anti-cancer agents must self-manage their symptoms with less interaction with oncology providers compared to infusion treatments. Symptoms and physical function are key patient-reported outcomes (PROs) and may lead to unscheduled health services uses (urgent care and emergency department [ED] visits, hospitalizations), which in turn lead to increased health care costs. OBJECTIVES: To evaluate the prediction of unscheduled health services uses using age, sex, and comorbidity, then determine the extent to which PRO data (symptoms and functioning) improve that prediction. METHODS: This post-hoc exploratory analysis was based on data from the control group of a trial of medication adherence reminder and symptom self-management intervention for people starting a new oral anti-cancer agent (n = 117 analyzed). Severity and interference with daily life for 18 symptoms, physical function, and depressive symptoms were assessed at intake (oral agent start), and four, eight, and 12 weeks later. Unscheduled health services use during three four-week periods after the start of oral agents was analyzed using generalized mixed effects models in relation to age, sex, comorbidity, and PROs at the beginning of each time period. RESULTS: The summed severity index of 18 symptoms and physical function were significant predictors of hospitalizations in the four weeks following PRO assessment. The addition of PROs improved areas under the receiver operating characteristic curves to be over .70 in most time periods. CONCLUSION: Monitoring of PROs has the potential of reducing unscheduled health services use if supportive care interventions are deployed based on their levels.

A literature review of coping strategies and health-related quality of life among patients with heart failure.

AIMS: To identify and provide clarity on factors that influence coping and the type of coping strategies used by patients with heart failure (HF) to improve health-related quality of life (HRQoL). METHODS AND RESULTS: The Arksey and O'Malley template framed this scoping review guided by the stress and coping model. Five databases were explored: PubMed, Web of Science, Cochrane, CINAHL, and PsycINFO. Keywords included HF, quality of life, coping, and influencing factors. Eligibility criteria involved patients with HF, reported on coping strategies and HRQoL, and published in English. Thirty-five studies were included (4 randomized controlled trials, 27 cross-sectional, and 4 qualitative/mixed methods). Active emotional coping (e.g. acceptance) and problem-focused (e.g. seeking social support) coping strategies were linked to better HRQoL, while avoidant emotional coping (e.g. denial) was linked to worse HRQoL. In the presence of the stressor of HF severity, key factors that influenced the types of the coping strategy included sex, age, social support, income, education, spiritual beliefs, and illness duration. However, the evidence on the effectiveness of the type of coping on HRQoL remains inadequate due to the majority of studies being cross-sectional. CONCLUSION: Problem-focused and active emotional coping strategies are associated with improved HRQoL. However, their effect is inconclusive due to the lack of experimental studies. Additional predictive studies will enhance the understanding of coping among HF patients.

The effects of SmartCare© on neuro-oncology family caregivers' distress: a randomized controlled trial.

PURPOSE: Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS: Family caregivers scoring ≥ 6 on a depressive symptoms inventory were randomized to three groups: ECAU plus self-guided CBT and SmartCare©; ECAU plus SmartCare©; ECAU only. Primary outcomes (depressive symptoms; caregiving-specific distress) and secondary outcomes (anxiety, caregiver mastery, and caregiver burden) were assessed online. Intention to treat (ITT) and per protocol (PP) analyses of covariance corrected for baseline scores were performed for outcomes at 4 months. RESULTS: In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n = 80) and compared to ECAU (n = 40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (ITT: p = 0.01, partial ɳ2 = 0.08; PP: p = 0.02, partial ɳ2 = 0.08). A trend towards improvement in mastery for the intervention group compared with ECAU was identified (ITT: p = 0.08, partial ɳ2 = 0.04; PP: p = 0.07, partial ɳ2 = 0.05). CONCLUSIONS: SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis. TRIAL REGISTRATION NUMBER: NCT02058745; 10 February 2014.

The Added Value of Family Caregivers' Level of Mastery in Predicting Survival of Glioblastoma Patients: A Validation Study.

BACKGROUND: Glioblastoma multiforme (GBM) is an aggressive brain tumor. Patients commonly rely on family caregivers for physical and emotional support. We previously demonstrated that caregiver mastery measured shortly after diagnosis was predictive of GBM patient survival, corrected for known predictors of survival (n = 88). OBJECTIVE: The aims of this study were to verify the contribution of caregiver mastery and investigate the added value of mastery over other predictors to predict 15-month survival. METHODS: Data collected for a longitudinal study (NCT02058745) were used. Multivariable Cox regression analyses were performed for models with known clinical predictors (patient age, Karnofsky Performance Status, type of surgery, O6-methylguanine-DNA-methyltransferase promotor methylation status), with and without adding caregiver mastery to predict mortality. The added value of each model in discriminating between patients with the lowest and highest chances of survival at 15 months was investigated through Harrell's concordance index. RESULTS: In total, 41 caregiver-patient dyads were included. When evaluating solely clinical predictors, Karnofsky Performance Status and patient age were significant predictors of mortality (hazard ratio [HR], 0.974; 95% confidence interval [CI], 0.949-1.000; and HR, 1.045; 95% CI, 1.002-1.091, respectively). Adding caregiver mastery, these clinical predictors remained statistically significant, and mastery showed an HR of 0.843 (95% CI, 0.755-0.940). The discriminative value improved from C = 0.641 (model with known clinical predictors) to C = 0.778 (model with mastery), indicating the latter is superior. CONCLUSIONS: We confirm that caregiver mastery is associated with GBM patient survival. IMPLICATIONS FOR PRACTICE: Incorporating support and guidance for caregivers into standard care could lead to benefits for caregiver well-being and patient outcomes.

Factors affecting medication beliefs among patients newly prescribed oral oncolytic agents.

BACKGROUND: Prescribing oral oncolytic agents (OAs) for advanced cancers is increasing. AIMS: To explore changes in medication beliefs and the effects of symptom severity, cognitive effectiveness and depressive symptoms on medication beliefs over 12 weeks. METHODS: Secondary analysis of a randomized controlled trial, testing an intervention to promote symptom management and adherence [N = 230]. Questionnaires evaluated medication beliefs, symptom severity, depressive symptoms, and cognitive effectiveness. Linear mixed effects models were used for analyses. RESULTS: OA Necessity beliefs increased over time (mean difference 0.0112, SE = 0.055, p 0.04). Concern beliefs did not change and were lower for advanced cancers (-0.193, SE = 0.067, p < 0.01).Depressive symptoms were related to decreased Necessity beliefs (-0.012, SE = 0.005, p = 0.02), but not Concern beliefs. Medication beliefs were not associated with symptom severity or cognitive effectiveness. CONCLUSION: Patients with advanced cancer hold different medication beliefs compared to earlier staged cancers, lending insight into potential outcomes beyond adherence.

Supportive health education reduces health care utilization and costs in Latinas with breast cancer and their caregivers.

PURPOSE: To compare costs and relative cost savings from reductions in unscheduled health services use for two 8-week psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE]) delivered by telephone to Latinas with breast cancer and their informal caregivers. Cost information is required before adopting supportive care interventions as part of routine care. There is limited information on costs of producing supportive care interventions or their impact on service use. METHODS: Latinas and their caregivers were randomized to either TIPC or SHE. At baseline and month 4, hospitalizations and urgent care and emergency department (ED) visits in the previous month were recorded. These were compared by trial arm for 181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline. RESULTS: Total cost per 100 survivors was $28,695 for SHE and $27,399 for TIPC. Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [0.12, 0.88], p = .03). For hospitalizations, OR for SHE versus TIPC was 0.59, 95% CI [0.26, 1.37], p = .07. There were no differences between trial arms for caregiver health services use. Cost savings for SHE versus TIPC from reductions in health services use per 100 survivors ranged from $800 for urgent care to $17,000 for ED visits and $13,000 for hospitalizations. CONCLUSIONS: Based on this evidence, SHE can be a cost-saving supportive care solution that benefits not only survivors and caregivers, but also oncology practices reimbursed through episodes of care.

Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes.

BACKGROUND: Self-management of symptoms related to cancer and its treatment is important for maintaining treatment regimens and improving outcomes. PURPOSE: To determine factors associated with engagement in a symptom self-management intervention among patients initiating oral anticancer treatment. METHODS: This secondary analysis included 127 patients randomized to the medication adherence reminder and symptom management intervention in a recently completed trial. Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms. During eight automated telephone weekly calls, patients were asked to use the Toolkit to manage elevated symptoms. Toolkit use and symptoms were tracked weekly, and generalized linear mixed-effects models were used to determine factors predictive of Toolkit use. General linear modeling was used to relate the Toolkit use during intervention to postintervention symptom severity. RESULTS: Better cognitive function at intake into the trial and higher symptom burden were predictive of the patients' initial decision to try the Toolkit during Week 1. In subsequent weeks, Toolkit use in the previous week and worsening of symptoms were associated with greater odds of Toolkit use. The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks. CONCLUSIONS: Patients make realistic decisions regarding when to use a self-directed approach to self-management and are likely to use strategies when their symptoms are higher and to forego use once symptoms subside. CLINICAL TRIAL REGISTRATION: NCT02043184.

How adverse events and permanent medication stoppages affect changes in patients' beliefs about oral antineoplastic agents.

BACKGROUND: Patients with advanced cancer often experience adverse events related to oral antineoplastic agents (OAAs) and permanent OAA medication stoppages, yet it is unknown how these factors impact medication beliefs. Such beliefs about OAA therapy may lend insight into decisions about continued cancer treatment near the end of life. PURPOSE: To explore relationships that adverse events and permanent OAA stoppages have on medication beliefs during the first 12 weeks following new OAA initiation. DESIGN: A secondary data analysis from a National Cancer Institute-funded randomized controlled trial testing an intervention to promote symptom management and OAA adherence. SETTING/SUBJECTS: Patients ≥ 21 years of age initiating a new course of OAA medication were recruited from six United States Comprehensive Cancer Centers. This analysis was based on a subset of patients with advanced disease (N = 60). MEASUREMENTS: Beliefs about Medicine Questionnaire, Common Terminology Criteria for Adverse Events, and medical records of permanent OAA stoppages. RESULTS: Significant decline in beliefs regarding the necessity of OAA medications existed between patients experiencing three or more adverse events and those experiencing a permanent OAA stoppage. CONCLUSIONS: Beliefs about the necessity of OAA medication change when physicians stop OAA medication or the patient experiences three or more adverse events. Concern regarding OAA medication did not change in response to medication stoppage or adverse events for this sample. Perhaps, patients with advanced cancers may be more accepting of adverse events that occur along the treatment trajectory and are not concerned about OAA medication once it is stopped. Findings suggest the importance of physicians' discussions of adverse events and decisions to permanently stop OAA medication as a means of transitioning to a new phase of cancer care that may include palliative or hospice considerations, given that beliefs about medication necessity are changing during these threats to cancer treatment.

Family Caregiving for Cancer Patients: the State of the Literature and a Direction for Research to Link the Informal and Formal Care Systems to Improve Quality and Outcomes.

OBJECTIVES: Based on recent shifts in reimbursement for cancer treatment from fee-for-service to bundled and value-based payment, this concluding article summarizes data from these papers and the large body of literature on caregiving to suggest how caregiving research might be redirected to link the formal with the informal systems to achieve higher-quality and lower-cost care. Caregiver dyads, the tasks of care, and strategies for training are presented. DATA SOURCES: Articles in this issue of Seminars in Oncology Nursing, the larger body of caregiving literature, and the Oncology Care Model driving bundled payments and value-based care. CONCLUSION: Research on informal caregiving for cancer patients should begin to reframe the rich body of evidence available toward a focus on caregivers reactions to the tasks of care, the training necessary for caregivers to perform them, and how each contributes to quality care at lower costs and appropriate outcomes given patients' stage of disease and goals of treatment. IMPLICATIONS FOR NURSING PRACTICE: Oncology systems must take a more active role in including patients and their families as partners to manage treatments and side effects to achieve the best possible patient outcomes. They must be able to evaluate the patient and the caregiver to determine what tasks they will be able to perform, and then make sure they have the training and resources to carry out those tasks. Training could be done by social media and through communication using patient portals that could be expanded through the electronic medical records to include caregiver portals, enabling caregiver questions and reports of patients' conditions.

Maximizing New Technologies to Treat Depression.

In an era of rapid technological evolution, mental healthcare providers are tapping into technology that offers feasible and effective alternatives to reach patients who suffer from depression. This paper provides a brief history and description of current technologies, frequently used taxonomies, and specific applications for the assessment and treatment of depression. These include online healthcare communities and social media, automated screening, wearable technology, and virtual reality therapy. A review of a secondary analysis that incorporated technology used with patients experiencing depressive symptoms is provided and future trends in mHealth or cellular-based technologies to treat depression are explored.

Conceptualisation of medication beliefs among patients with advanced cancer receiving oral oncolytic agents using a theory derivation approach.

OBJECTIVE: This paper describes a derived model that provides a conceptual framework for understanding medication beliefs among patients with advanced cancer receiving oral oncolytic agents. METHODS: Theory derivation was used to (a) examine the phenomenon of medication beliefs in cross-disciplinary research; (b) select a parent theory for derivation; (c) identify parent theory concepts and/or structure to use in derivation; and (d) redefine parent theory concepts and structure to create a derived model. RESULTS: Medication beliefs are shaped by previous experiences, including cognitive and emotional factors, past health and illness encounters, and medication-taking behaviours. Medication beliefs are defined within a larger mental model of illness representation for which medication was prescribed. Individuals independently hold both positive and negative medication beliefs at the same time. This distinction is critical to understanding how dichotomous components of medication beliefs change over time as they are influenced by varying treatment-related factors. CONCLUSION: This paper contributes to conceptual knowledge regarding the phenomenon of medication beliefs and their impact on health behaviour. Findings can support oncology interventions to improve patient outcomes including medication adherence.

Latent Transition Analysis of the Symptom Experience of Cancer Patients Undergoing Chemotherapy.

BACKGROUND: Symptom clusters reflect the person's experience of multiple cooccurring symptoms. Although a variety of statistical methods are available to address the clustering of symptoms, latent transition analysis (LTA) characterizes patient membership in classes defined by the symptom experience and captures changes in class membership over time. OBJECTIVES: The purposes of this article are to demonstrate the application of LTA to cancer symptom data and to discuss the advantages and disadvantages of LTA relative to other methods of managing and interpreting data on multiple symptoms. METHODS: Data from a total of 495 adult cancer patients who participated in randomized clinical trials of two symptom management interventions were analyzed. Eight cancer- and treatment-related symptoms reflected the symptom experience. Latent transition analysis was employed to identify symptom classes and evaluate changes in symptom class membership from baseline to the end of the interventions. RESULTS: Three classes, "A (mild symptoms)," "B (physical symptoms)," and "C (physical and emotional symptoms)," were identified. Class A patients had less comorbidity, better physical and emotional role effect, and better physical function than the other classes did. The number of symptoms, general health perceptions, and social functioning were significantly different across the three classes and were poorest in Class C. Emotional role functioning was poorest in Class C. Older adults were more likely to be in Class B than younger adults were. Younger adults were more likely to be in Class C (p < .01). Among patients in Class C at baseline, 41.8% and 29.0%, respectively, transitioned to Classes A and B at the end of the interventions. DISCUSSION: These results demonstrate that symptom class membership characterizes differences in the patient symptom experience, function, and quality of life. Changes in class membership represent longitudinal changes in the course of symptom management. Latent class analysis overcomes the problem of multiple statistical testing that separately addresses each symptom.

Effects of depressive symptomatology on cancer-related symptoms during oral oncolytic treatment.

OBJECTIVE: This manuscript assesses association between depressive symptoms and symptoms from cancer and its treatment during the first 12 weeks of a new oral oncolytic treatment. METHODS: This secondary analysis used data from a recently completed trial of an intervention to improve adherence to oral oncolytic treatment and manage symptoms. Following the initiation of the new oral oncolytic medication, 272 patients were interviewed at intake and weeks 4, 8, and 12 to assess depressive symptoms, and symptoms from cancer and its treatment. Depressive symptoms were measured using the Center for Epidemiologic Studies-Depression (CES-D20). The summed index of 18 cancer-related and treatment-related symptoms as well as the number of symptoms above threshold at intake, weeks 4, 8, and 12 were related to intake and time-varying CES-D20 using linear mixed effects models. RESULTS: Depressive symptomatology was a significant predictor of cancer-related and treatment-related symptoms at all-time points, but the strength of this relationship was greatest at the time of oral oncolytic agent initiation and at week 4. The strength of this relationship was the same for both summed symptom severity index and the number of symptoms above threshold, and using either intake or time-varying CES-D20. CONCLUSION: Introducing strategies to treat and manage symptoms of depression along with other symptoms might have added benefits among patients who start a new oral oncolytic treatment and report modest to higher levels of depressive symptoms. Assessments for the impact of strategies to lower depressive symptoms can be taken within the first 4 weeks.

An Automated Intervention Did Not Improve Adherence to Oral Oncolytic Agents While Managing Symptoms: Results From a Two-Arm Randomized Controlled Trial.

CONTEXT: An increasing number of oral cancer treatments require patient adherence and symptom self-management. OBJECTIVES: The report presents the effects of a medication reminder and symptom management intervention directed at patients initiating new oral oncolytic agents. METHODS: Patients (N = 272) were recruited at six comprehensive cancer centers, interviewed over the telephone after oral agent initiation, and randomized to either standard care or a medication reminder and symptom management intervention. In the intervention arm, the automated system called patients daily to remind them about taking their medications and weekly to assess 18 symptoms and refer patients to a printed Medication Management and Symptom Management Toolkit. Severity of 18 symptoms was also assessed during telephone interviews at Week 4 (midintervention), Week 8 (postintervention), and Week 12 (follow-up). Adherence was measured using the relative dose intensity, the ratio of dose taken by patient out of dose prescribed by the oncologist, and assessed using pill counts at Weeks 4, 8, and 12 and prescribing information from medical records. RESULTS: The relative dose intensity was high and did not differ by trial arm. Symptom severity was significantly lower (P < 0.01) in the experimental arm at Week 8 but not at Weeks 4 or 12. CONCLUSION: Adherence may be less of a problem than originally anticipated, and intervention was not efficacious possibly because of already high rates of patient adherence to oral oncolytic medication during first 12 weeks. Longer follow-up in future research may identify subgroups of patients who need interventions to sustain adherence.

Challenges to the design and testing supportive interventions for cancer patients treated with oral oncolytic agents.

Conducting research into supportive care for patients as they initiate treatment with oral oncolytic agents poses numerous new challenges. Some of these medications have very complex dosing schedules and produce symptoms that patients need to manage at home with less reliance on oncology clinicians. We describe lessons learned from a multi-site trial designed to improve adherence to these medications and self-management of symptoms among patients newly prescribed oral oncolytic agents. Identifying these challenges can assist researchers to improve the integrity of their future supportive care trials.