Five Dimensions of Needs for Help: The Efficacy of a Technology-Based Intervention Among Asian American Breast Cancer Survivors.

Cancer survivors including Asian American breast cancer survivors have reported their high needs for help during their survivorship process. With the COVID-19 pandemic, the necessity of technology-based programs to address their needs for help without face-to-face interactions has been highlighted. The purpose of this randomized intervention study was to determine the efficacy of a technology-based program in reducing various types of needs for help among this specific population. This was a randomized clinical trial with repeated measures. A total of 199 participants were included in the data analysis. The recruitment settings included both online and offline communities/groups for Asian Americans. The needs for help were assessed using the Support Care Needs Survey-34 Short Form (SCNS) subscales measuring psychological, information, physical, support, and communication needs. Data analysis was conducted through an intent-to-treat approach. In the mixed effect models, psychological needs, information needs, physical needs, and communication needs decreased over time (P < .001). However, there were no significant group * time effects. Social support significantly mediated the effects of a technology-based intervention on psychological, information, and support needs at the pre-test and the post-1 month. This study supported significant decreases in the needs for help of Asian American breast cancer survivors by a technology-based intervention. Further studies are needed with other racial/ethnic groups of cancer survivors to confirm the efficacy of a technology-based intervention in reducing cancer survivors' needs for help during their survivorship process.

Informed Consent among Clinical Trial Participants with Different Cancer Diagnoses.

IMPORTANCE: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials. OBJECTIVE: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type. DESIGN AND SETTING AND PARTICIPANTS: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334). MAIN OUTCOME MEASURES: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type. RESULTS: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT. CONCLUSIONS AND RELEVANCE: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

A randomized controlled trial testing a virtual program for Asian American women breast cancer survivors.

A culturally tailored virtual program could meet the survivorship needs of Asian American women breast cancer survivors (AABC). This study aims to determine the efficacy of a culturally tailored virtual information and coaching/support program (TICAA) in improving AABC's survivorship experience. A randomized clinical trial (NCT02803593) was conducted from January 2017 to June 2020 among 199 AABC. The intervention group utilized TICAA and the American Cancer Society [ACS] website while the control group used only ACS website for 12 weeks. The outcomes were measured using the SCNS-34SF (needs; primary), the MSAS-SF (symptoms; secondary), and the FACT-B (quality of life; secondary). The data were analyzed using an intent-to-treat approach. The intervention group showed significant reductions in their needs from the baseline (T0) to post 4 weeks (T1) and to post 12 weeks (T2). Although the changes were not statistically significant, the intervention group had decreased symptoms from T0 to T2 while the control group had an increase in their symptoms. The intervention group had a significant increase in their quality of life from T0 to T2. A culturally tailored virtual program could therefore improve quality of life in AABC patients. Trial Registration: To Enhance Breast Cancer Survivorship of Asian Americans (TICAA), NCT02803593, https://clinicaltrials.gov/ct2/show/NCT02803593?titles=TICAA&draw=2&rank=1.

Assessing and Understanding Reactance, Self-Exemption, Disbelief, Source Derogation and Information Conflict in Reaction to Overdiagnosis in Mammography Screening: Scale Development and Preliminary Validation.

PURPOSE: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet some people may react to overdiagnosis with doubt and skepticism. The present research assessed 4 related reactions to overdiagnosis: reactance, self-exemption, disbelief, and source derogation (REDS). The degree to which the concept of overdiagnosis conflicts with participants' prior beliefs and health messages (information conflict) was also assessed as a potential antecedent of REDS. We developed a scale to assess these reactions, evaluated how those reactions are related, and identified their potential implications for screening decision making. METHODS: Female participants aged 39 to 49 years read information about overdiagnosis in mammography screening and completed survey questions assessing their reactions to that information. We used a multidimensional theoretical framework to assess dimensionality and overall domain-specific internal consistency of the REDS and Information Conflict questions. Exploratory and confirmatory factor analyses were performed using data randomly split into a training set and test set. Correlations between REDS, screening intentions, and other outcomes were evaluated. RESULTS: Five-hundred twenty-five participants completed an online survey. Exploratory and confirmatory factor analyses identified that Reactance, Self Exemption, Disbelief, Source Derogation, and Information Conflict represent unique constructs. A reduced 20-item scale was created by selecting 4 items per construct, which showed good model fit. Reactance, Disbelief, and Source Derogation were associated with lower intent to use information about overdiagnosis in decision making and the belief that informing people about overdiagnosis is unimportant. CONCLUSIONS: REDS and Information Conflict are distinct but correlated constructs that are common reactions to overdiagnosis. Some of these reactions may have negative implications for making informed screening decisions. HIGHLIGHTS: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet when provided information about overdiagnosis, some people are skeptical.This research developed a measure that assessed different ways in which people might express skepticism about overdiagnosis (reactance, self-exemption, disbelief, source derogation) and also the perception that overdiagnosis conflicts with prior knowledge and health messages (information conflict).These different reactions are distinct but correlated and are common reactions when people learn about overdiagnosis.Reactance, disbelief, and source derogation are associated with lower intent to use information about overdiagnosis in decision making as well as the belief that informing people about overdiagnosis is unimportant.

Estimating Pack-Year Eligibility for Lung Cancer Screening Using 2 Yes or No Questions.

This cross-sectional study describes the development and testing the accuracy of using 2 yes or no questions to estimate pack-year eligibility for lung cancer screening.

Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

Importance: Guidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice. Objective: To evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake. Design, Setting, and Participants: This randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Milwaukee, Wisconsin; and West Haven, Connecticut, from March 18, 2019, to September 29, 2021, with follow-up through July 18, 2022. Individuals aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate. Individuals with LCS within 15 months were excluded. Of 1047 individuals who were sent a recruitment letter or had referred themselves, 140 were enrolled. Intervention: A web-based patient- and clinician-facing LCS decision support tool vs an attention control intervention. Main Outcome and Measures: The primary outcome was decisional conflict at 1 month. Secondary outcomes included decisional conflict immediately after intervention and 3 months after intervention, knowledge, decisional regret, and anxiety immediately after intervention and 1 and 3 months after intervention and LCS by 6 months. Results: Of 140 enrolled participants (median age, 64.0 [IQR, 61.0-69.0] years), 129 (92.1%) were men and 11 (7.9%) were women. Of 137 participants with data available, 75 (53.6%) were African American or Black and 62 (44.3%) were White; 4 participants (2.9%) also reported Hispanic or Latino ethnicity. Mean decisional conflict score at 1 month did not differ between the LCSDecTool and control groups (25.7 [95% CI, 21.4-30.1] vs 29.9 [95% CI, 25.6-34.2], respectively; P = .18). Mean LCS knowledge score was greater in the LCSDecTool group immediately after intervention (7.0 [95% CI, 6.3-7.7] vs 4.9 [95% CI, 4.3-5.5]; P < .001) and remained higher at 1 month (6.3 [95% CI, 5.7-6.8] vs 5.2 [95% CI, 4.5-5.8]; P = .03) and 3 months (6.2 [95% CI, 5.6-6.8] vs 5.1 [95% CI, 4.4-5.8]; P = .01). Uptake of LCS was greater in the LCSDecTool group at 6 months (26 of 69 [37.7%] vs 15 of 71 [21.1%]; P = .04). Conclusions and Relevance: In this randomized clinical trial of an LCSDecTool compared with attention control, no effect on decisional conflict occurred at 1 month. The LCSDecTool used in the primary care setting did not yield a significant difference in decisional conflict. The intervention led to greater knowledge and LCS uptake. These findings can inform future implementation strategies and research in LCS shared decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT02899754.

Association of Diet Patterns and Post-Operative Tympanostomy Tube Otorrhea: A Pilot Study.

OBJECTIVE: The objective of this study was to explore diet patterns in children with tympanostomy tube placement (TTP) complicated by postoperative tympanostomy tube otorrhea. STUDY DESIGN: Cross-sectional survey and retrospective cohort study. METHODS: Caregivers of children (0-12 years old), at a tertiary-care pediatric hospital who underwent TTP within 6 months to 2 years prior to enrollment were included. Children with a history of Down syndrome, cleft palate, craniofacial syndromes, known immunodeficiency, or a non-English-speaking family were excluded. Our primary outcome variable was the number of otorrhea episodes. The primary predictor was diet patterns, particularly dessert intake, which was captured through a short food questionnaire. RESULTS: A total of 286 participants were included in this study. The median age was 1.8 years (IQR, 1.3, 2.9). A total of 174 (61%) participants reported at least one episode of otorrhea. Children who consumed dessert at least two times per week had a higher risk of otorrhea compared to children who consumed one time per week or less (odds ratio [OR], 3.22, 95% Confidence Interval [CI]: 1.69, 6.12). The odds ratio increase continued when considering more stringent criteria for otorrhea (multiple episodes or one episode occurring 4 weeks after surgery), with a 2.33 (95% CI: 1.24, 4.39) higher odds of otorrhea in children with dessert intake at least 2 times per week. CONCLUSIONS: Our pilot data suggest that episodes of otorrhea among children with TTP were associated with more frequent dessert intake. Future studies using prospectively administered diet questionnaires are necessary to confirm these findings. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:3575-3581, 2023.

Association of Perceived Benefit or Burden of Research Participation With Participants' Withdrawal From Cancer Clinical Trials.

Importance: Attrition in cancer clinical trials (CCTs) can lead to systematic bias, underpowered analyses, and a loss of scientific knowledge to improve treatments. Little attention has focused on retention, especially the role of perceived benefits and burdens, after participants have experienced the trial. Objectives: To examine the association between patients' perceived benefits and burdens of research participation and CCT retention. Design, Setting, and Participants: This survey study was conducted at a National Cancer Institute-designated comprehensive cancer center in the Northeast region of the US. The sample included adult patients with a cancer diagnosis participating in cancer therapeutic trials. Data were collected from September 2015 to June 2019. Analysis of study data was ongoing since November 2019 through October 2022. Exposures: Self-reported validated survey instrument with a list of 22 benefits and 23 burdens of research participation that can be rated by patients with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Main Outcomes and Measures: A primary outcome was actual withdrawal from the CCT, and a composite outcome was composite withdrawal that included both actual withdrawal and thoughts of withdrawing. Bivariate and multivariable logistic regressions were used. Results: Among the 334 participants in the sample, the mean (SD) age was 61.9 (11.5) years and 174 women (52.1%) were included. Top-cited benefits included both aspirational and action-oriented goals, including helping others (94.2%), contributing to society (90.3%), being treated respectfully (86.2%), and hoping for a cure (86.0%). Worry over receiving a placebo (61.3%), rearranging one's life (41.9%), and experiencing bothersome adverse effects (41.6%) were notable burdens. An increased burden score was associated with a higher probability of actual withdrawal (adjusted odds ratio [OR], 1.86; 95% CI, 1.1-3.17; P = .02) or composite withdrawal (adjusted OR, 3.44; 95% CI, 2.09-5.67; P < .001). An increased benefit score was associated with lower composite withdrawal (adjusted OR, 0.40; 95% CI, 0.24-0.66; P < .001). For participants who reported the benefits as being equal to or greater than the burdens, 13.4% withdrew. For those who perceived the benefits as being less than the burdens, 33.3% withdrew (adjusted OR, 3.38; 95% CI, 1.13-10.14; P = .03). The risk of withdrawal was even higher for the composite outcome (adjusted OR, 7.70; 95% CI, 2.76-21.48; P < .001). Conclusions and Relevance: This survey study found that patients perceived important benefits from CCT participation, and this perception was associated with trial retention, even among those who also perceived substantial burdens. A broader dialogue among stakeholders can inform an ethical and patient-centric focus on benefits throughout the course of a CCT to increase retention.

Colorectal Cancer Screening During the COVID-19 Pandemic.

Shared decision-making (SDM) can help patients make good decisions about preventive health interventions such as cancer screening. We illustrate the use of SDM in the case of a 53-year-old man who had a new patient visit with a primary care physician and had never been screened for colorectal cancer (CRC). The patient had recently recovered from a serious COVID-19 infection requiring weeks of mechanical ventilation. When the primary care physician initially offered a screening colonoscopy, the man expressed great reluctance to return to the hospital for the exam. The PCP then offered a stool test, which could be completed at home, but emphasized that if it were positive, a colonoscopy would be required. He agreed to complete the stool test, and unfortunately, it was positive. He then agreed to undergo colonoscopy, which uncovered a large rectal cancer. The carcinoma had invaded the mesorectal fat but there were no metastases. After undergoing neoadjuvant chemotherapy followed by a low anterior resection of the tumor, he has no evidence of recurrence so far. Many clinicians favor colonoscopy for CRC screening, but evidence suggests that patients who are offered more than one reasonable option are more likely to undergo screening. If screening had been delayed in this patient until he was willing to accept a screening colonoscopy, there was the potential the cancer may have been more advanced when diagnosed, with a worse outcome. Shared decision-making was a key approach to understanding the patient's feelings related to this screening decision and making a decision consistent with his preferences.

Intensity of end-of-life care for gynecologic cancer patients by primary oncologist specialty.

OBJECTIVE: The association of primary oncologist specialty, medical oncology versus gynecologic oncology, on intensity of care at the end of life in elderly patients with gynecologic cancer is unclear. METHODS: This retrospective cohort study used Surveillance, Epidemiology and End Results-Medicare (SEER-M) data. Subjects were fee-for-service Medicare enrollees aged 65 years and older who died of a gynecologic cancer between January 2006 and December 2015. The primary outcome was a composite score for high-intensity care received in the last month of life. Secondary outcomes included invasive procedures and Medicare spending in the last month of life. Simple and multivariable linear and logistic regression analyses evaluated differences in outcomes by primary oncologist specialty. Linear regressions were repeated after creating a more similar control group through nearest-neighbor propensity score matching. RESULTS: Of 12 189 patients, 7705 (63%) had a medical primary oncologist in the last year of life. In adjusted analyses, patients with a gynecologic versus medical primary oncologist received lower rates of high-intensity end-of-life care (53.9% vs 56.6%; p=0.018). Results were similar for the propensity score-matched cohorts. However, having a gynecologic versus medical primary oncologist was associated with higher rates of invasive procedures in the last month of life (43% vs 41%; p=0.014) and higher Medicare spending ($83 859 vs $74 849; p=0.004). CONCLUSIONS: Both specialties engage in overall high levels of intense end-of-life care, with differences by specialty in aspects of aggressive care and spending at the end of life. Physician-level training could be a target for educational or quality improvement initiatives to improve end-of-life cancer care delivery.

A Veteran-Centric Web-Based Decision Aid for Lung Cancer Screening: Usability Analysis.

BACKGROUND: Web-based tools developed to facilitate a shared decision-making (SDM) process may facilitate the implementation of lung cancer screening (LCS), an evidence-based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that affect the benefits and potential harms of LCS and thus may value a veteran-centric LCS decision tool (LCSDecTool). OBJECTIVE: This study aims to conduct usability testing of an LCSDecTool designed for veterans receiving care at a Veteran Affairs medical center. METHODS: Usability testing of the LCSDecTool was conducted in a prototype version (phase 1) and a high-fidelity version (phase 2). A total of 18 veterans and 8 clinicians participated in phase 1, and 43 veterans participated in phase 2. Quantitative outcomes from the users included the System Usability Scale (SUS) and the End User Computing Satisfaction (EUCS) in phase 1 and the SUS, EUCS, and Patient Engagement scale in phase 2. Qualitative data were obtained from observations of user sessions and brief interviews. The results of phase 1 informed the modifications of the prototype for the high-fidelity version. Phase 2 usability testing took place in the context of a pilot hybrid type 1 effectiveness-implementation trial. RESULTS: In the phase 1 prototype usability testing, the mean SUS score (potential range: 0-100) was 81.90 (SD 9.80), corresponding to an excellent level of usability. The mean EUCS score (potential range: 1-5) was 4.30 (SD 0.71). In the phase 2 high-fidelity usability testing, the mean SUS score was 65.76 (SD 15.23), corresponding to a good level of usability. The mean EUCS score was 3.91 (SD 0.95); and the mean Patient Engagement scale score (potential range 1 [low] to 5 [high]) was 4.62 (SD 0.67). The median time to completion in minutes was 13 (IQR 10-16). A thematic analysis of user statements documented during phase 2 high-fidelity usability testing identified the following themes: a low baseline level of awareness and knowledge about LCS increased after use of the LCSDecTool; users sought more detailed descriptions about the LCS process; the LCSDecTool was generally easy to use, but specific navigation challenges remained; some users noted difficulty understanding medical terms used in the LCSDecTool; and use of the tool evoked veterans' struggles with prior attempts at smoking cessation. CONCLUSIONS: Our findings support the development and use of this eHealth technology in the primary care clinical setting as a way to engage veterans, inform them about a new cancer control screening test, and prepare them to participate in an SDM discussion with their provider.

Designing a Cancer Prevention Collaborative Goal-Setting Mobile App for Non-Hispanic Black Primary Care Patients: An Iterative, Qualitative Patient-Led Process.

BACKGROUND: There remains a need to engage at-risk primary care populations in cancer prevention behaviors, yet primary care physicians often lack the time or resources to discuss these behaviors with their patients. OBJECTIVE: The objective of this study is to evaluate the content, usability, and acceptability of a mobile app that leverages insights from goal-setting and social network literature to facilitate cancer prevention goal setting, tracking, and sharing between non-Hispanic Black primary care patients and their social ties. METHODS: We recruited eligible non-Hispanic Black primary care patients (aged ≥18 years) from 2 practice sites in West Philadelphia, using nonprobabilistic purposive sampling. We conducted semistructured interviews with 5 to 7 participants over 3 weeks to solicit feedback on paper mock-ups of the app, iteratively adapting these mock-ups after each set of interviews. Thereafter, and informed by initial feedback, we created an electronic beta version of the app and sought acceptability and usability feedback from a different set of participants. Then, we conducted content analysis of all user responses to search for unifying themes on acceptability and usability of both the initial mock-ups and beta version of the app. We further assessed app usability using questions derived from the System Usability Scale. RESULTS: A total of 33 non-Hispanic Black primary care patients participated in this study. The mean age was 49 (SD 13) years, and 26 (79%) out of 33 participants identified as female. Semistructured interviews revealed three primary generalizable insights from our target population: the framing of each goal and its relevance to cancer impacted the likelihood that the goal would be chosen, participants thought that sharing health goals with others facilitates health behaviors, and most participants found it motivating to see other users' goal progress, while still collaborating with these users on their health goals. An overarching insight that permeated across each theme was the participants' desire to customize and personalize the app. Usability testing revealed that 100% (33/33) of participants found the app easy to use, and 76% (25/33) of participants reported that they would like to use this app frequently. CONCLUSIONS: Cancer prevention in the modern era must include options that are accessible to all, but this does not mean that all options must be universal. This study's iterative process led to the development of a cancer prevention mobile app that non-Hispanic Black primary care patients deemed usable and acceptable and yielded noteworthy insights about what intended end users value in setting and accomplishing health goals.

Racial Disparities in Adherence to Annual Lung Cancer Screening and Recommended Follow-Up Care: A Multicenter Cohort Study.

Rationale: Black patients receive recommended lung cancer screening (LCS) follow-up care less frequently than White patients, but it is unknown if this racial disparity persists across both decentralized and centralized LCS programs. Objectives: To determine adherence to American College of Radiology Lung Imaging Reporting and Data System (Lung-RADS) recommendations among individuals undergoing LCS at either decentralized or centralized programs and to evaluate the association of race with LCS adherence. Methods: We performed a multicenter retrospective cohort study of patients receiving LCS at five heterogeneous U.S. healthcare systems. We calculated adherence to annual LCS among patients with a negative baseline screen (Lung-RADS 1 or 2) and recommended follow-up care among those with a positive baseline screen (Lung-RADS 3, 4A, 4B, or 4X) stratified by type of LCS program and evaluated the association between race and adherence using multivariable modified Poisson regression. Results: Of the 6,134 total individuals receiving LCS, 5,142 (83.8%) had negative baseline screens, and 992 (16.2%) had positive baseline screens. Adherence to both annual LCS (34.8% vs. 76.1%; P < 0.001) and recommended follow-up care (63.9% vs. 74.6%; P < 0.001) was lower at decentralized compared with centralized programs. Among individuals with negative baseline screens, a racial disparity in adherence was observed only at decentralized screening programs (interaction term, P < 0.001). At decentralized programs, Black race was associated with 27% reduced adherence to annual LCS (adjusted relative risk [aRR], 0.73; 95% confidence interval [CI], 0.63-0.84), whereas at centralized programs, no effect by race was observed (aRR, 0.98; 95% CI, 0.91-1.05). In contrast, among those with positive baseline screens, there was no significant difference by race for adherence to recommended follow-up care by type of LCS program (decentralized aRR, 0.95; 95% CI, 0.81-1.11; centralized aRR, 0.81; 95% CI, 0.71-0.93; interaction term, P = 0.176). Conclusions: In this large multicenter study of individuals screened for lung cancer, adherence to both annual LCS and recommended follow-up care was greater at centralized screening programs. Black patients were less likely to receive annual LCS than White patients at decentralized compared with centralized LCS programs. Our results highlight the need for further study of healthcare system-level mechanisms to optimize longitudinal LCS care.

Patient-Physician Concordance for Quantitative Formats and Treatment Options and the Relationship with State Anxiety.

Patient-physician concordance about topics discussed in a clinic visit is essential for effective communication but may be difficult to achieve in cancer care. We conducted a multicenter, observational study at two Midwestern oncology clinics. A sample of 48 English-speaking or Spanish-speaking women with newly diagnosed stage 0-3 breast cancer completed surveys before and after a visit with an oncologist. Patient-physician dyads were coded as concordant if both patient and physician follow-up self-reports agreed whether (or not) specific treatments were discussed (i.e., treatment option concordance; mastectomy, lumpectomy, hormone therapy, neoadjuvant, and adjuvant chemotherapy) and whether risk was described using certain quantitative formats (i.e., quantitative format concordance; percentages, proportions out of 100 and 1000, graphs, pictures, evidence from clinical studies, cancer stage). Agreement was determined using percent agreement and prevalence-adjusted bias-adjusted kappa (PABAK). Pearson's correlations were used to determine relationships between anxiety and each measure concordance. Percent concordance was higher for treatment concordance (73.3%) compared to quantitative format concordance (64.5%), and PABAK scores tended to be higher for treatment options (PABAK = .21-.78). Both treatment and quantitative format concordance were negatively associated with pre-visit state anxiety, but only treatment concordance was statistically significant (treatment: r = - .504, p = .001; quantitative format: r = - .096, p = .523). Our study indicates moderate patient-physician concordance in early breast cancer care communication and that patient anxiety may impact the ability for patients and physicians to agree on the content communicated in a clinic visit.

Willingness to Travel for Cellular Therapy: The Influence of Follow-Up Care Location, Oncologist Continuity, and Race.

PURPOSE: Patients weigh competing priorities when deciding whether to travel to a cellular therapy center for treatment. We conducted a choice-based conjoint analysis to determine the relative value they place on clinical factors, oncologist continuity, and travel time under different post-treatment follow-up arrangements. We also evaluated for differences in preferences by sociodemographic factors. METHODS: We administered a survey in which patients with diffuse large B-cell lymphoma selected treatment plans between pairs of hypothetical options that varied in travel time, follow-up arrangement, oncologist continuity, 2-year overall survival, and intensive care unit admission rate. We determined importance weights (which represent attributes' value to participants) using generalized estimating equations. RESULTS: Three hundred and two patients (62%) responded. When all follow-up care was at the center providing treatment, plans requiring longer travel times were less attractive (v 30 minutes, importance weights [95% CI] of -0.54 [-0.80 to -0.27], -0.57 [-0.84 to -0.29], and -0.17 [-0.49 to 0.14] for 60, 90, and 120 minutes). However, the negative impact of travel on treatment plan choice was mitigated by offering shared follow-up (importance weights [95% CI] of 0.63 [0.33 to 0.93], 0.32 [0.08 to 0.57], and 0.26 [0.04 to 0.47] at 60, 90, and 120 minutes). Black participants were less likely to choose plans requiring longer travel, regardless of follow-up arrangement, as indicated by lower value importance weights for longer travel times. CONCLUSION: Reducing travel burden through shared follow-up may increase patients' willingness to travel to receive cellular therapies, but additional measures are required to facilitate equitable access.

Adapting the design of a Web-based decision support clinical trial during the COVID-19 pandemic.

BACKGROUND: The public health crises that emerged in the COVID-19 pandemic significantly impacted the provision of medical care and placed sudden restrictions on ongoing clinical research. Patient-facing clinical research confronted unique challenges in which recruitment and study protocols were halted and then adapted to meet safety procedures during the pandemic. Our study protocol included the use of a Lung Cancer Screening Decision Tool (LCSDecTool) in the context of a primary care visit and was considerably impacted by the pandemic. We describe our experience adapting a multi-site clinical trial of the LCSDecTool within the Department of Veterans Affairs Health Care System. We conducted a randomized controlled trial (RCT) comparing the LCSDecTool to a control intervention. Outcomes included lung cancer screening (LCS) knowledge, shared decision-making, and uptake and adherence to LCS protocol. We identified three strategies that led to the successful adaptation of the study design during the pandemic: (1) multi-level coordination and communication across the organization and study sites, (2) flexibility and adaptability in research during a time of uncertainty and changes in regulation, and (3) leveraging technology to deliver the intervention and conduct study visits, which raised issues concerning equity and internal and external validity. CONCLUSION: Our experience highlights strategies successfully employed to adapt an intervention and behavioral research study protocol during the COVID-19 pandemic. This experience will inform clinical research moving forward both during and subsequent to the constraints placed on research and clinical care during the COVID-19 pandemic.

Promoting Collaborative Goal Setting for Cancer Prevention Among Primary Care Patients Through mHealth: Mixed Methods Evaluation of a New App.

BACKGROUND: Many newly diagnosed cancers are associated with modifiable lifestyle behaviors, such as diet, exercise, smoking cessation, and maintaining a healthy weight. However, primary care providers rarely discuss cancer prevention behaviors with their patients. OBJECTIVE: This study aims to assess the usability, acceptability, and user engagement of the Healthier Together mobile app, which is designed to promote cancer prevention behaviors among non-Hispanic Black primary care patients, by using social networks and goal-setting theories of behavior change. METHODS: In an 8-week pilot study, we enrolled primary care patients (N=41) and provided them with a cancer prevention mobile app that allowed them to select, track, and share progress on cancer prevention goals with other users. App usability was assessed using the System Usability Scale. We assessed the app's acceptability by qualitatively analyzing open-ended responses regarding participants' overall experience with the app. We assessed participants' engagement by analyzing the built-in data capture device, which included the number of times participants checked in (out of a maximum of 8) during the study. RESULTS: The mean age of the 41 participants was 51 years (SD 12), and 76% (31/41) were women. App use data were captured from all participants, and 83% (34/41) completed the exit survey and interview. The mean System Usability Scale score was 87 (SD 12; median 90; IQR 78-95). The analysis of open-ended responses revealed several key themes, and participants complemented the app's ease of use and health behavior-promoting features while also commenting on the need for more feedback and social interactions through the app. On average, participants checked in 5.7 times (SD 2.7) out of 8 possible opportunities. Of the 41 participants, 76% (31/41) checked in during at least 4 of the 8 weeks. Secondary analyses revealed that participants often accomplished their set goals (mean 5.1, SD 2.7) for each week. The qualitative analysis of comments given by participants within the app after each weekly check-in revealed several themes on how the app assisted participants in behavioral change, highlighting that some participants created exercise programs, ate healthier foods, lost a significant amount of weight, and stopped smoking during this study. CONCLUSIONS: The implementation of a mobile cancer prevention goal-setting app in a primary care setting was feasible, and the app achieved high usability, acceptability, and engagement among participants. User feedback revealed an influence on health behaviors. These findings suggest the promise of the Healthier Together app in facilitating behavioral change to reduce cancer risk among non-Hispanic Black primary care patients.

When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes.

BACKGROUND: A shared decision-making (SDM) process for lung cancer screening (LCS) includes a discussion between clinicians and patients about benefits and potential harms. Expert-driven taxonomies consider mortality reduction a benefit and consider false-positives, incidental findings, overdiagnosis, overtreatment, radiation exposure, and direct and indirect costs of LCS as potential harms. OBJECTIVE: To explore whether patients conceptualize the attributes of LCS differently from expert-driven taxonomies. DESIGN: Cross-sectional study with semistructured interviews and a card-sort activity. PARTICIPANTS: Twenty-three Veterans receiving primary care at a Veterans Affairs Medical Center, 55 to 73 y of age with 30 or more pack-years of smoking. Sixty-one percent were non-Hispanic African American or Black, 35% were non-Hispanic White, 4% were Hispanic, and 9% were female. APPROACH: Semistructured interviews with thematic coding. MAIN MEASURES: The proportion of participants categorizing each attribute as a benefit or harm and emergent themes that informed this categorization. KEY RESULTS: In addition to categorizing reduced lung cancer deaths as a benefit (22/23), most also categorized the following as benefits: routine annual screening (8/9), significant incidental findings (20/23), follow-up in a nodule clinic (20/23), and invasive procedures (16/23). Four attributes were classified by most participants as a harm: false-positive (13/22), overdiagnosis (13/23), overtreatment (6/9), and radiation exposure (20/22). Themes regarding the evaluation of LCS outcomes were 1) the value of knowledge about body and health, 2) anticipated positive and negative emotions, 3) lack of clarity in terminology, 4) underlying beliefs about cancer, and 5) risk assessment and tolerance for uncertainty. CONCLUSIONS: Anticipating discordance between patient- and expert-driven taxonomies of the benefits and harms of LCS can inform the development and interpretation of value elicitation and SDM discussions.