A qualitative analysis of algorithm-based decision support usability testing for symptom management across the trajectory of cancer care: one size does not fit all.

BACKGROUND: Adults with cancer experience symptoms that change across the disease trajectory. Due to the distress and cost associated with uncontrolled symptoms, improving symptom management is an important component of quality cancer care. Clinical decision support (CDS) is a promising strategy to integrate clinical practice guideline (CPG)-based symptom management recommendations at the point of care. METHODS: The objectives of this project were to develop and evaluate the usability of two symptom management algorithms (constipation and fatigue) across the trajectory of cancer care in patients with active disease treated in comprehensive or community cancer care settings to surveillance of cancer survivors in primary care practices. A modified ADAPTE process was used to develop algorithms based on national CPGs. Usability testing involved semi-structured interviews with clinicians from varied care settings, including comprehensive and community cancer centers, and primary care. The transcripts were analyzed with MAXQDA using Braun and Clarke's thematic analysis method. A cross tabs analysis was also performed to assess the prevalence of themes and subthemes by cancer care setting. RESULTS: A total of 17 clinicians (physicians, nurse practitioners, and physician assistants) were interviewed for usability testing. Three main themes emerged: (1) Algorithms as useful, (2) Symptom management differences, and (3) Different target end-users. The cross-tabs analysis demonstrated differences among care trajectories and settings that originated in the Symptom management differences theme. The sub-themes of "Differences between diseases" and "Differences between care trajectories" originated from participants working in a comprehensive cancer center, which tends to be disease-specific locations for patients on active treatment. Meanwhile, participants from primary care identified the sub-theme of "Differences in settings," indicating that symptom management strategies are care setting specific. CONCLUSIONS: While CDS can help promote evidence-based symptom management, systems providing care recommendations need to be specifically developed to fit patient characteristics and clinical context. Findings suggest that one set of algorithms will not be applicable throughout the entire cancer trajectory. Unique CDS for symptom management will be needed for patients who are cancer survivors being followed in primary care settings.

Concordance between influential adverse treatment outcomes and localized prostate cancer treatment decisions.

BACKGROUND: Although treatment decisions for localized prostate cancer (LPC) are preference-sensitive, the extent to which individuals with LPC receive preference-concordant treatment is unclear. In a sample of individuals with LPC, the purpose of this study was to (a) assess concordance between the influence of potential adverse treatment outcomes and treatment choice; (b) determine whether receipt of a decision aid predicts higher odds of concordance; and (c) identify predictors of concordance from a set of participant characteristics and influential personal factors. METHODS: Participants reported the influence of potential adverse treatment outcomes and personal factors on treatment decisions at baseline. Preference-concordant treatment was defined as (a) any treatment if risk of adverse outcomes did not have a lot of influence, (b) active surveillance if risk of adverse outcomes had a lot of influence, or (c) radical prostatectomy or active surveillance if risk of adverse bowel outcomes had a lot of influence and risk of other adverse outcomes did not have a lot of influence. Data were analyzed using descriptive statistics and logistic regression. RESULTS: Of 224 participants, 137 (61%) pursued treatment concordant with preferences related to adverse treatment outcomes. Receipt of a decision aid did not predict higher odds of concordance. Low tumor risk and age ≥ 60 years predicted higher odds of concordance, while attributing a lot of influence to the impact of treatment on recreation predicted lower odds of concordance. CONCLUSIONS: Risk of potential adverse treatment outcomes may not be the foremost consideration of some patients with LPC. Assessment of the relative importance of patients' stated values and preferences is warranted in the setting of LPC treatment decision making. CLINICAL TRIAL REGISTRATION: NCT01844999 ( www. CLINICALTRIALS: gov ).

Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk.

BACKGROUND: Decision support tools improve decisional conflict and elicit patient preferences related to prostate cancer treatment. It was hypothesized that men using the Personal Patient Profile-Prostate (P3P) would be more likely to pursue guideline-concordant treatment. METHODS: Men from a trial assessing the P3P decision support intervention were identified. The primary exposure was allocation to P3P (vs usual care), and the outcome was appropriate treatment per guidelines (eg, low risk = active surveillance). It was assessed whether providers recommended against any treatment options (ie, restricted). A multivariable model was fit for men with low-risk cancer that estimated the odds of the outcome of interest. RESULTS: This study identified 295 men in the cohort: 113 (38%) had low-risk disease, 119 (40%) had favorable intermediate-risk disease, and 63 (21%) had unfavorable intermediate-risk disease. Among low-risk patients, more men pursued active surveillance after using P3P whether they were given unrestricted (62% vs 54% with usual care; P = .54) or restricted options (71% vs 59% with usual care; P = .34). After adjustments, only Black race (odds ratio [OR], 0.31; 95% CI, 0.11-0.89) and restricted options (OR, 0.23; 95% CI, 0.08-0.65) had an inverse association with the receipt of surveillance for patients with low-risk prostate cancer. An impact associated with P3P versus usual care (OR, 0.89; 95% CI, 0.36-2.20) was not observed. CONCLUSIONS: Among men in a trial assessing a decision support tool, Black race and restricted treatment options were associated with less use of active surveillance for low-risk prostate cancer. Although the P3P instrument ameliorates decisional conflict, its use was not associated with more appropriate alignment of treatment with disease risk.

The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study.

BACKGROUND: Breast cancer patients undergoing mastectomy with reconstruction (TM + R) often experience post-operative discomfort from surgical drains. Despite a variety of garment options for use in the post-operative period, high-quality data assessing the impact of specific garments on post-operative pain are lacking. We report the results of a prospective randomized trial assessing the impact of the Jacki Jacket (JJ), a long-sleeve jacket with inner drain receptacle pockets, on post-discharge pain and quality of life (QOL) after TM + R. METHODS: Breast cancer patients undergoing TM + R at a single institution were randomized post-operatively to receive a JJ or usual care (UC). Participant-reported demographics, pain intensity, and QOL were collected on post-operative day 1 (T1). Following discharge, participants completed a daily pain and medication dairy (T2); on day of drain(s) removal (T3), participants again completed pain and QOL questionnaires. Linear models were used to evaluate associations between JJ use, post-operative pain, and QOL. RESULTS: From 3/8/17 to 12/20/17, 139 women were randomized. All participants completed T1 measures, 102 returned the T2 diary, and 118 (84.9%) completed T3 questionnaires. There was no significant difference in pain scores between JJ and UC arms at any timepoint. Adjusting for surgery type, age, marital status, depression, and obesity, participants randomized to JJ reported significantly better body image scores (estimate = 12.94, p = 0.009). There were no adverse events. CONCLUSIONS: Although JJ garment use did not impact post-operative pain intensity scores, the significant impact of JJ use on body image supports consideration for inclusion of such garments in post-operative care for patients undergoing TM + R. CLINICAL TRIAL REGISTRATION INFORMATION: Registered with ClinicalTrials.gov, NCT number NCT02976103, November 18, 2016.

Correction to: Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy.

...

Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis.

BACKGROUND: The Personal Patient Profile-Prostate (P3P) is a web-based decision support system for men newly diagnosed with localized prostate cancer that has demonstrated efficacy in reducing decisional conflict. Our objective was to estimate willingness-to-pay (WTP) for men's decisional preparation activities. METHODS: In a multicenter, randomized trial of P3P, usual care group participants received typical preparation for decision making plus referral to publicly-available, educational websites. Intervention group participants received the same, plus online P3P educational media specific to the user's personal preferences and values, and a communication coaching component tailored to race\ethnicity, age and language. WTP data were collected one week after physician consultation. An iterative bidding direct contingent valuation survey format was used, randomly assigning participants to high or low starting values (SV). Tobit models were used to explore associations between SV-adjusted WTP and age, education, marital and work-status, insurance, decision-control preference and decision-making stage. RESULTS: Of 392 participants enrolled, 141 P3P and 107 usual care (UC) provided a WTP value. Men were willing to pay a median $25 (IQR $10-100) for P3P in addition to usual care preparation materials. In the final multivariable tobit regression model, SV, marital status, stage of decision making and income were significantly associated with WTP for P3P. Decision control preference was considered marginally significant (p = 0.11). Men were WTP a median $30 (IQR $10-$200) for usual care material alone. In the final multivariable model, SV, education, and stage of decision making were significantly associated with WTP in usual care. CONCLUSION: WTP was similar for UC and for the addition of P3P to UC decision preparation. The WTP values were associated with demographic and preference variables. Findings can help focus decision support on future patients who would benefit most: those without strong support systems, at earlier stages of decision making, and open to a shared-decision style. TRIAL REGISTRATION: NCT NCT01844999 . Registered May 3, 2013.

Decision Support with the Personal Patient Profile-Prostate: A Multicenter Randomized Trial.

PURPOSE: We evaluated the efficacy of the web based P3P (Personal Patient Profile-Prostate) decision aid vs usual care with regard to decisional conflict in men with localized prostate cancer. MATERIALS AND METHODS: A randomized (1:1), controlled, parallel group, nonblinded trial was performed in 4 regions of the United States. Eligible men had clinically localized prostate cancer and an upcoming consultation, and they spoke and read English or Spanish. Participants answered questionnaires to report decision making stage, personal characteristics, concerns and preferences plus baseline symptoms and decisional conflict. A randomization algorithm allocated participants to receive tailored education and communication coaching, generic teaching sheets and external websites plus a 1-page summary to clinicians (intervention) or the links plus materials provided in clinic (usual care). Conflict outcomes and the number of consultations were measured at 1 month. Univariate and multivariable models were used to analyze outcomes. RESULTS: A total of 392 men were randomized, including 198 to intervention and 194 to usual care, of whom 152 and 153, respectively, returned 1-month outcomes. The mean ± SD 1-month decisional conflict scale (score range 0 to 100) was 10.9 ± 16.7 for intervention and 9.9 ± 18.0 for usual care. The multivariable model revealed significantly reduced conflict in the intervention group (-5.00, 95% CI -9.40--0.59). Other predictors of conflict included income, marital or partner status, decision status, number of consultations, clinical site and D'Amico risk classification. CONCLUSIONS: In this multicenter trial the decision aid significantly reduced decisional conflict. Other variables impacted conflict and modified the effect of the decision aid, notably risk classification, consultations and resources. P3P is an effective adjunct for shared decision making in men with localized prostate cancer.

Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy.

BACKGROUND: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia. METHODS: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age. RESULTS: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control. CONCLUSION: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation. TRIAL REGISTRATION: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009.

Psychosocial outcomes of an electronic self-report assessment and self-care intervention for patients with cancer: a randomized controlled trial.

BACKGROUND: The use of Web-based technology to facilitate self-care and communication with health care providers has the potential to improve psychosocial outcomes for patients undergoing cancer treatment. This study reports an analysis of psychosocial outcomes of the electronic self-report assessment for cancer study. METHODS: Adult patients starting cancer therapy were randomized to receive usual education about symptoms and quality of life topics (control) or usual education plus self-care instruction for symptoms and quality of life issues, communication coaching, and the opportunity to track symptoms and quality of life between clinic visits (intervention). Depression (Patient Health Questionnaire-9) and social, emotional, and role functioning (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 subscales) were measured before treatment (T1), 3 to 6 weeks after starting treatment (T2), 2 weeks later (T3), and 2 to 4 weeks after treatment ended or at the next restaging visit for participants who continued to receive treatment (T4). Clinicians received summaries of participant reports at each time point in both groups. RESULTS: In multivariable analysis, the depression scores were significantly lower (P = .04) and there was a trend to higher social and role functioning (P = .07) in the intervention group compared with the control. Working status was significantly associated with lower depression and better social and role functioning. CONCLUSIONS: A patient-centered, Web-based intervention that facilitates self-care and communication can improve psychosocial outcomes in the cancer setting.

Usability Testing the "Personal Patient Profile-Prostate" in a Sample of African American and Hispanic Men.

Shared treatment decision making in a cancer setting requires a patient's understanding of the potential benefits and risks of each treatment option. Graphical display of risk information is one approach to improving understanding. Little is known about how patients engage with infographics in the context of health education materials and whether interactions vary with health literacy levels. We conducted an observational study, using an eye tracker device, of how men with newly diagnosed localized prostate cancer visually engaged with an on-screen infographic depicting risk information in the Personal Patient Profile-Prostate. Health literacy was measured with the Short Assessment of Health Literacy-English. Gaze patterns on an exemplar screens containing infographics about survival were analyzed and explored with respect to sociodemographic and health literacy data. Acceptability of Personal Patient Profile-Prostate was measured with the Acceptability E-scale. Twenty-six English-speaking men participated, and eye tracking data were collected for 12 men on the exemplar page of risk information that we analyzed. We found preliminary evidence of visual scanning and of participants with lower literacy focusing sooner on infographics versus text. Acceptability for Personal Patient Profile-Prostate was high. These findings suggest that infographics may be of higher relative value to participants with low health literacy. Eye trackers may provide valuable information on how people visually engage with infographics and may inform development of health education materials, although care must be taken to minimize data loss.

Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

BACKGROUND: Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness. OBJECTIVE: The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress. METHODS: Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients' homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ≥2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher's exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample. RESULTS: Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group. CONCLUSIONS: The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use. TRIAL REGISTRATION: Clinicaltrials.gov NCT00852852; http://clinicaltrials.gov/ct2/show/NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7).

Usability evaluation and adaptation of the e-health Personal Patient Profile-Prostate decision aid for Spanish-speaking Latino men.

BACKGROUND: The Personal Patient Profile-Prostate (P3P), a web-based decision aid, was demonstrated to reduce decisional conflict in English-speaking men with localized prostate cancer early after initial diagnosis. The purpose of this study was to explore and enhance usability and cultural appropriateness of a Spanish P3P by Latino men with a diagnosis of prostate cancer. METHODS: P3P was translated to Spanish and back-translated by three native Spanish-speaking translators working independently. Spanish-speaking Latino men with a diagnosis of localized prostate cancer, who had made treatment decisions in the past 24 months, were recruited from two urban clinical care sites. Individual cognitive interviews were conducted by two bilingual research assistants as each participant used the Spanish P3P. Notes of user behavior, feedback, and answers to direct questions about comprehension, usability and perceived usefulness were analyzed and categorized. RESULTS: Seven participants with a range of education levels identified 25 unique usability issues in navigation, content comprehension and completeness, sociocultural appropriateness, and methodology. Revisions were prioritized to refine the usability and cultural and linguistic appropriateness of the decision aid. CONCLUSIONS: Usability issues were discovered that are potential barriers to effective decision support. Successful use of decision aids requires adaptation and testing beyond translation. Our findings led to revisions further refining the usability and linguistic and cultural appropriateness of Spanish P3P.

The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial.

BACKGROUND: The electronic self report assessment - cancer (ESRA-C), has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress (SD). METHODS: Patients at two cancer centers were randomized to ESRA-C assessment only (control) or the Web-based ESRA-C intervention delivered to patients' homes or to a tablet in clinic. The intervention allowed patients to self-monitor symptom and quality of life (SxQOL) between visits, receive self-care education and coaching to report SxQOL to clinicians. Summaries of assessments were delivered to clinicians in both groups. Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues, focusing on patients'/caregivers' coached verbal reports of SxQOL severity, pattern, alleviating/aggravating factors and requests for help. Among issues identified as problematic, two measures were defined for each patient: the percent SxQOL reported that included a coached statement, and an index of verbalized coached statements per SxQOL. The Wilcoxon rank test was used to compare measures between groups. Clinician responses to problematic SxQOL were compared. A mediation analysis was conducted, exploring the effect of verbal reports on SD outcomes. RESULTS: 517 (256 intervention) clinic visits were audio-recorded. General discussion of problematic SxQOL was similar in both groups. Control group patients reported a median 75% of problematic SxQOL using any specific coached statement compared to a median 85% in the intervention group (p = .0009). The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group (p = 0.008). Fatigue, pain and physical function issues were reported significantly more often in the intervention group (all p < .05). Clinicians' verbalized responses did not differ between groups. Patients' verbal reports did not mediate final SD outcomes (p = .41). CONCLUSIONS: Adding electronically-delivered, self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone. However, clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients' reports. TRIAL REGISTRATION: NCT00852852; 26 Feb 2009.

Communication about symptoms and quality of life issues in patients with cancer: provider perceptions.

This study used qualitative data collection and analysis methods to describe provider perceptions of addressing patient-initiated communication about common or sensitive symptom and quality of life issues (SQIs) in oncology. Eligible participants were health care providers who had participated in a larger trial testing a patient-centered technology to assess cancer SQIs and support self-care. Audio-recorded vignettes were simulated based on recorded clinic visits from the larger trial and presented during semi-structured cognitive interviews with each participant. Transcripts of the interviews were content analyzed. Twelve providers participated. Participants' responses included four themes: the institutional and clinical context, the complexity of addressing SQIs, strategies used to understand SQIs, and creating a plan to address SQIs. Participants felt that approaching SQIs inside and outside of the clinic required ongoing communication within a multidisciplinary team both to gather information and manage the SQI. Forming a relationship with the patient was one strategy to facilitate assessing SQIs. Most participants expressed a need for guidance about effective SQI communication. Providers perceived approaching SQIs as a routine part of interdisciplinary clinical care. The specific symptom and the complexity of its management influenced the process of assessing and managing SQIs. Findings have implications for institutional processes, training, evaluation, and program development.

Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer.

PURPOSE: In patients with lung cancer, dyspnea is one of the most prevalent and disabling symptoms, for which effective treatments are lacking. We examined the efficacy of a nurse-led brief behavioral intervention to improve dyspnea in patients with advanced lung cancer. METHODS: Patients with advanced lung cancer reporting at least moderate breathlessness (n = 247) were enrolled in a randomized trial of a nurse-led two-session intervention (focused on breathing techniques, postural positions, and fan therapy) versus usual care. At baseline and weeks 8 (primary end point), 16, and 24, participants completed measures of dyspnea (Modified Medical Research Council Dyspnea Scale [mMRCDS]; Cancer Dyspnoea Scale [CDS]), quality of life (Functional Assessment of Cancer Therapy-Lung [FACT-L]), psychological symptoms (Hospital Anxiety and Depression Scale), and activity level (Godin-Shephard Leisure Time Physical Activity Questionnaire). To examine intervention effects, we conducted analysis of covariance and longitudinal mixed effects models. RESULTS: The sample (Agemean = 66.15 years; 55.9% female) primarily included patients with advanced non-small cell lung cancer (85.4%). Compared with usual care, the intervention improved the primary outcome of patient-reported dyspnea on the mMRCDS (difference = -0.33 [95% CI, -0.61 to -0.05]) but not the CDS total score at 8 weeks. Intervention patients also reported less dyspnea on the CDS sense of discomfort subscale (difference = -0.59 [95% CI, -1.16 to -0.01]) and better functional well-being per the FACT-L (difference = 1.39 [95% CI, 0.18 to 2.59]) versus the control group. Study groups did not differ in overall quality of life, psychological symptoms, or activity level at 8 weeks or longitudinally over 24 weeks. CONCLUSION: For patients with advanced lung cancer, a scalable behavioral intervention alleviated the intractable symptom of dyspnea. Further research is needed on ways to enhance intervention effects over the long-term and across additional outcomes.

Designing a Dyad-Based Digital Health Intervention to Reduce Sedentary Time in Black Breast Cancer Survivors and Their First-degree Relatives: Human-Centered Design Study.

BACKGROUND: Breast cancer, the most commonly diagnosed cancer and second leading cause of cancer-related death in women in the United States, disproportionately affects women from minoritized or low socioeconomic backgrounds. The average woman has an approximately 12% lifetime risk of developing breast cancer. Lifetime risk nearly doubles if a woman has a first-degree relative with breast cancer, and the risk increases as multiple family members are affected. Decreasing sedentary behaviors through moving more and sitting less reduces breast cancer risk and improves outcomes for cancer survivors and healthy adults. Digital health solutions, such as mobile apps that are culturally appropriate, designed with input from the target audience, and include social support, are effective at improving health behaviors. OBJECTIVE: This study aimed to develop and evaluate the usability and acceptability of a prototype app designed with a human-centered approach to promote moving more and sitting less in Black breast cancer survivors and their first-degree relatives (parent, child, or sibling). METHODS: This 3-phase study consisted of app development, user testing, and evaluation of user engagement and usability. Key community stakeholders were engaged in the first 2 (qualitative) phases to provide input into developing the prototype app (MoveTogether). After development and user testing, a usability pilot was conducted. Participants were adult breast cancer survivors who identified as Black and agreed to participate with a relative. Participants used the app and a step-tracking watch for 4 weeks. App components included goal setting and reporting, reminders, dyad messaging, and educational resources. Usability and acceptability were assessed with a questionnaire that included the System Usability Scale (SUS) and semistructured interviews. Data were analyzed with descriptive statistics and content analysis. RESULTS: Participants in the usability pilot (n=10) were aged 30 to 50 years (6/10, 60%), not married (8/10, 80%), and college graduates (5/10, 50%). The app was used on average 20.2 (SD 8.9) out of 28 days-SUS score of 72 (range 55-95)-and 70% (7/10) agreed that the app was acceptable, helpful, and gave them new ideas. Additionally, 90% (9/10) found the dyad component helpful and would recommend the app to friends. Qualitative findings suggest that the goal-setting feature was helpful and that the dyad partner (buddy) provided accountability. Participants were neutral regarding the cultural appropriateness of the app. CONCLUSIONS: The MoveTogether app and related components were acceptable for promoting moving more in dyads of breast cancer survivors and their first-degree relatives. The human-centered approach, which involved engaging community members in the development, is a model for future technology development work. Future work should be done to further develop the intervention based on the findings and then test its efficacy to improve sedentary behavior while considering culturally informed strategies for adoption and implementation within the community. TRIAL REGISTRATION: ClinicalTrials.gov NCT05011279; https://clinicaltrials.gov/ct2/show/NCT05011279.

Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer.

BACKGROUND: Men diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group. METHODS: English/Spanish-speaking men diagnosed with LPC (2007-2009) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire. Men were randomized to receive the P3P intervention or standard education plus links to reputable websites. We classified choice as concordant if men were concerned with (a) sexual function and chose external beam radiotherapy or brachytherapy, (b) bowel function and chose prostatectomy, (c) sex, bowel, and/or bladder function and chose active surveillance, or (d) not concerned with any side effect and chose any treatment. Using logistic regression, we calculated odds ratios (OR) and 95% confidence intervals (CI) for the association between the P3P intervention and concordance. RESULTS: Of 448 men, most were <65 years, non-Hispanic white, had multiple physician consultations prior to enrollment, and chose a treatment discordant with concerns about potential side effects. There was no significant difference in concordance between the intervention (45%) and control (50%) group (OR = 0.82; 95%CI = 0.56, 1.2). CONCLUSIONS: The P3P intervention did not improve concordance between potential side effects and treatment choice. Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects. The intervention may be more effective before the first treatment options consultation. TRIAL REGISTRATION: NCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653.

Clinical Decision Support for Symptom Management in Lung Cancer Patients: A Group RCT.

CONTEXT: Clinical guidelines are available to enhance symptom management during cancer treatment but often are not used in the practice setting. Clinical decision support can facilitate the implementation and adherence to clinical guidelines. and improve the quality of cancer care. OBJECTIVES: Clinical decision support offers an innovative approach to integrate guideline-based symptom management into oncology care. This study evaluated the effect of clinical decision support-based recommendations on clinical management of symptoms and health-related quality of life (HR-QOL) among outpatients with lung cancer. METHODS: Twenty providers and 179 patients were allotted in group randomization to attention control (AC) or Symptom Assessment and Management Intervention (SAMI) arms. SAMI entailed patient-report of symptoms and delivery of recommendations to manage pain, fatigue, dyspnea, depression, and anxiety; AC entailed symptom reporting prior to the visit. Outcomes were collected at baseline, two, four and six-months. Adherence to recommendations was assessed through masked chart review. HR-QOL was measured by the Functional Assessment of Cancer Therapy-Lung questionnaire. Descriptive statistics with linear and logistic regression accounting for the clustering structure of the design and a modified chi-square test were used for analyses. RESULTS: Median age of patients was 63 years, 58% female, 88% white, and 32% ≤high school education. Significant differences in clinical management were evident in SAMI vs. AC for all target symptoms that passed threshold. Patients in SAMI were more likely to receive sustained-release opioids for constant pain, adjuvant medications for neuropathic pain, opioids for dyspnea, stimulants for fatigue and mental health referrals for anxiety. However, there were no statistically significant differences in HR-QOL at any time point. CONCLUSION: SAMI improved clinical management for all target symptoms but did not improve patient outcomes. A larger study is warranted to evaluate effectiveness.

Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care.

The performance of the Acceptability E-scale was tested in a sample of 627 adult and older adult patients from various oncology clinics who completed an electronic symptoms survey. The revised Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs in oncology and other health population.