Acute cancer-related symptoms and concerns among patients receiving chemotherapy: current state of the science.

PURPOSE: This study provides an updated evaluation of the prevalence and severity of acute cancer-related symptoms and quality of life (QOL) concerns among patients treated with emetogenic chemotherapy. METHODS: Patients were recruited to a larger, multi-site observational study prior to starting chemotherapy. Participants completed sociodemographic questionnaires and clinical data were abstracted via medical record review. Symptoms and QOL were assessed 5 days after starting moderately or highly emetogenic chemotherapy. Functional Assessment of Cancer Therapy - General assessed QOL concerns. Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events evaluated symptoms. Symptoms were considered severe when participants responded "severe" or "very severe." RESULTS: Participants (N = 1174) were on average 58 ± 13 years, mostly female (73%), non-Hispanic (89%), and White (87%). Most participants were diagnosed with breast (38.1%), gynecological (20%), and gastrointestinal (17.1%) cancer. The most common QOL concerns of any severity were fatigue (94%), anhedonia (89%), dissatisfaction with QOL (86%), and sleep disturbance (86%). The most common severe QOL concerns were anhedonia (44%), fatigue (40%), and inability to work (38%). Decreased appetite (74%), pain (71%), and constipation (70%) were the most common symptoms of any severity, as well as most common severe symptoms (13%, 18%, and 18%, respectively). CONCLUSION: Herein, updates are provided in regard to QOL concerns and symptoms reported by patients in the days after chemotherapy and demonstrates that concerns and symptoms have shifted in the last decade.

Exploring Patients' Understanding of Chemotherapy-Induced Peripheral Neuropathy.

Little quantitative evidence exists surrounding patients' level of understanding of chemotherapy-induced peripheral neuropathy (CIPN) symptoms (numbness, tingling, pain in the hands/feet) and consequences (e.g., negatively affect physical functioning or chemotherapy dosing) at the beginning of chemotherapy. The purpose of this cross-sectional, secondary analysis was to describe CIPN knowledge and education patterns among adults early in a course of neurotoxic chemotherapy for the treatment of cancer (< three infusions). Following consent, participants completed an electronic questionnaire about their perceptions of CIPN symptoms, incidence, and education. Participants (N = 92) were mainly female (76%), white (91%), and diagnosed with breast (46%) or gastrointestinal (40%) cancers. Most participants without CIPN (n = 48) did not expect to develop CIPN (45%) or were unaware of CIPN as a side-effect (30%). Furthermore, 71% of participants without CIPN (n = 31) estimated CIPN to occur in ≤ 30% of patients receiving neurotoxic chemotherapy. Overall, participants learned about CIPN from their doctor or nurse prior to beginning chemotherapy (90%). Clinicians delivered education about CIPN symptoms (75%), but less frequently delivered education about CIPN management (14%), or the impact of CIPN on the ability to continue chemotherapy (16%) or physical functioning (24%). Finally, participants reported that a discussion with their doctor/nurse would be the best way to learn about CIPN (92%). Results revealed that participants without CIPN were largely unaware of the adverse consequences or incidence of CIPN during treatment. Further research is needed to investigate optimal methods to promote patient-clinician communication about CIPN during chemotherapy to enhance patients' retention of CIPN information and activation in their care.

Communicating is analogous to caring: A systematic review and thematic synthesis of the patient-clinician communication experiences of individuals with ovarian cancer.

OBJECTIVE: To systematically review and synthesize the patient-clinician communication experiences of individuals with ovarian cancer. METHODS: The CINAHL, Embase, MEDLINE, PsycINFO, and Web of Science databases were reviewed for articles that described (a) original qualitative or mixed methods research, (b) the experiences of individuals with ovarian cancer, and (c) findings related to patient-clinician communication. Relevant data were extracted from study results sections, then coded for descriptive and analytical themes in accordance with Thomas and Harden's approach to thematic synthesis. Data were coded by two authors and discrepancies were resolved through discussion. RESULTS: Of 1,390 unique articles, 65 met criteria for inclusion. Four descriptive themes captured participants' experiences communicating with clinicians: respecting me, seeing me, supporting me, and advocating for myself. Findings were synthesized into three analytical themes: communication is analogous to caring, communication is essential to personalized care, and communication may mitigate or exacerbate the burden of illness. SIGNIFICANCE OF RESULTS: Patient-clinician communication is a process by which individuals with ovarian cancer may engage in self-advocacy and appraise the extent to which they are seen, respected, and supported by clinicians. Strategies to enhance patient-clinician communication in the ovarian cancer care setting may promote patient perceptions of patient-centered care.

Metagenomics and chemotherapy-induced nausea: A roadmap for future research.

Uncontrolled chemotherapy-induced nausea and vomiting can reduce patients' quality of life and may result in premature discontinuation of chemotherapy. Although nausea and vomiting are commonly grouped together, research has shown that antiemetics are clinically effective against chemotherapy-induced vomiting (CIV) but less so against chemotherapy-induced nausea (CIN). Nausea remains a problem for up to 68% of patients who are prescribed guideline-consistent antiemetics. Despite the high prevalence of CIN, relatively little is known regarding its etiology independent of CIV. This review summarizes a metagenomics approach to the study and treatment of CIN with the goal of encouraging future research. Metagenomics focuses on genetic risk factors and encompasses both human (ie, host) and gut microbial genetic variation. Little work to date has focused on metagenomics as a putative biological mechanism of CIN. Metagenomics has the potential to be a powerful tool in advancing scientific understanding of CIN by identifying new biological pathways and intervention targets. The investigation of metagenomics in the context of well-established demographic, clinical, and patient-reported risk factors may help to identify patients at risk and facilitate the prevention and management of CIN.

The Evolving Story of Mesh Mid Urethral Slings: The Surgeon's Perspective.

PURPOSE: The objective of this study was to obtain the perspectives of surgeons who treat female stress urinary incontinence (SUI) and better understand their range of experiences with mesh mid urethral sling (MUS) surgery. MATERIALS AND METHODS: This qualitative study recruited gynecologic and urological surgeons who treat SUI. Surgeons were interviewed by phone and in person using a standardized interview guide. Interviews were transcribed, de-identified, and analyzed by 2 independent researchers. The transcripts were coded and summarized using the principles of thematic analysis. The research team came to consensus that a saturation of ideas representing a diverse demographic of surgeons had been achieved. RESULTS: Twenty-four interviews of surgeons from diverse geographic locations and practice types were performed. Many surgeons described MUS surgery as rewarding and favorably impactful for women with SUI, while others grappled with the serious risks associated with MUS surgery. Those who had treated women with life-altering pain after MUS recounted impactful patient stories. Many stated that recognition, acknowledgement, and appropriate referral of complications were fundamental to responsible and ethical care. Some surgeons expressed frustration and concern about the raised level of controversy and anxiety regarding the MUS landscape. All participants expressed that there was substantial room for improvement in multiple domains. Participants also shared their optimal strategies relevant to MUS surgery. CONCLUSIONS: Despite diverse views regarding the role of the MUS, there was agreement among surgeons that the surgeon-patient relationship, thorough informed consent and patient counseling, and accountability are essential when implanting MUSs.

How does patient-centered communication in ovarian cancer care enhance patient well-being? A mixed methods study.

OBJECTIVE: Greater perceived patient-centered communication (PCC) is associated with better health-related quality of life (HRQoL) in patients with ovarian cancer. Quantitative measures of PCC and HRQoL do little to explain this association. We interviewed patients with high and low ratings of PCC to understand how it is associated with HRQoL. METHODS: Explanatory sequential mixed methods study. Participants were English-speaking U.S. adults with ovarian cancer. We assessed PCC with the Patient-Centered Communication - Cancer (PCC-Ca)-36 (possible score range 1-5; higher scores represent greater patient-centeredness), and purposively sampled 14 participants with total scores in the top and bottom quartiles. Participants completed individual, semi-structured interviews about their communication experiences. Guided by the National Cancer Institute Framework for PCC in Cancer Care, we analyzed interview transcripts using directed content analysis. We integrated survey and interview findings in a joint display. RESULTS: Among 176 survey respondents, PCC-Ca-36 total scores ranged from 1.7 to 5.0. Participants with scores in the top quartile (4.8-5.0) perceived clinicians as proactive and attentive to psychosocial concerns. Those with scores in the bottom quartile (1.7-3.5) described not feeling known as an individual and receiving limited support for self-management. CONCLUSIONS: The association between PCC and QoL may be partially explained by differences in perceived support for psychosocial concerns and self-management. PCC may facilitate receipt of proactive, personalized care.

Diet quality indices and changes in cognition during chemotherapy.

PURPOSE: No evidence-based prevention strategies currently exist for cancer-related cognitive decline (CRCD). Although patients are often advised to engage in healthy lifestyle activities (e.g., nutritious diet), little is known about the impact of diet on preventing CRCD. This secondary analysis evaluated the association of pre-treatment diet quality indices on change in self-reported cognition during chemotherapy. METHODS: Study participants (n = 96) completed the Block Brief Food Frequency Questionnaire (FFQ) before receiving their first infusion and the PROMIS cognitive function and cognitive abilities questionnaires before infusion and again 5 days later (i.e., when symptoms were expected to be their worst). Diet quality indices included the Dietary Approaches to Stop Hypertension (DASH), Alternate Mediterranean Diet (aMED), and a low carbohydrate diet index and their components. Descriptive statistics were generated for demographic and clinical variables and diet indices. Residualized change models were computed to examine whether diet was associated with change in cognitive function and cognitive abilities, controlling for age, sex, cancer type, treatment type, depression, and fatigue. RESULTS: Study participants had a mean age of 59 ± 10.8 years and 69% were female. Although total diet index scores did not predict change in cognitive function or cognitive abilities, higher pre-treatment ratio of aMED monounsaturated/saturated fat was associated with less decline in cognitive function and cognitive abilities at 5-day post-infusion (P ≤ .001). CONCLUSIONS: Higher pre-treatment ratio of monounsaturated/saturated fat intake was associated with less CRCD early in chemotherapy. Results suggest greater monounsaturated fat and less saturated fat intake could be protective against CRCD during chemotherapy.

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 ).

Functional Goals and How Palliative Patients With Cancer Managed Pain.

BACKGROUND: High rates of pain impede quality of life for persons with advanced cancer. Research has identified barriers to cancer pain control. Little has been written, however, about the unique motivating goals and individual pain management behaviors of persons with cancer-related pain. AIMS: To describe motivating factors and pain management behaviors used. DESIGN: Quantitative content analysis. SETTINGS: Outpatient palliative care Participants: 27 persons with cancer pain. METHODS: We analyzed deidentified audio recordings from participants who had completed motivational interviewing interventions to discuss functional pain goals. We organized data into a priori conceptual categories: (1) Pain as an Obstacle, (2) Life with Controlled Pain, (3) What Helped Pain Before, (4) Suggestions Used to Control Pain, and (5) Patient Help-Seeking. Unique behaviors, attitudes, and personal states were counted and organized categorically. RESULTS: Medians for discussed concepts ranged from 0.5-3 occurrences across a sample of 108 interviews. The least discussed concept was Help-Seeking and the most frequently discussed was Controlled Pain based on personal motivations. CONCLUSIONS: Current cancer pain assessment tools do not capture the unique complexities of cancer pain motivating behaviors, or personal functional goals, and thus hinder nurses' capacity to provide tailored care across patient encounters. Until a measure with specificity to capture unique patient goals is developed, nurses must rely on their own skills to comprehend if and how motivating factors could benefit individual cancer pain management plans.

Self-Reported Severity, Characteristics, and Functional Limitations of Chemotherapy-Induced Peripheral Neuropathy.

BACKGROUND: The early identification of chemotherapy-induced peripheral neuropathy (CIPN) (e.g., numbness or tingling in the fingers or toes) is important due to its frequency and the few effective treatment options available. The identification of common patient-reported CIPN characteristics and associated functional limitations may help to facilitate patient-clinician discussions of CIPN in practice. AIMS: To quantify the severity, duration, location, characteristics, and associated functional limitations of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. DESIGN: Exploratory secondary analysis of a prospective, two-phase study SETTING: Breast, gastrointestinal, and multiple myeloma clinics at Dana-Farber Cancer Institute. PARTICIPANTS: 142 individuals who planned to receive at least three more cycles of neurotoxic chemotherapy after consent. METHODS: Participants self-reported CIPN using standardized measures (i.e., PRO-CTCAE™ Numbness and Tingling Items or 0-10 numerical rating scale of worst CIPN pain intensity) and/or study team generated follow up questions about CIPN location, duration, characteristics, and functional limitations prior to three consecutive clinic visits (T1, T2, T3). Participants' responses to the CIPN self-report questionnaires were described by chemotherapy type and age. RESULTS: Over approximately 36.5 days (T1-T3), the percentage of participants reporting at least mild CIPN increased from 59.3% to 71%. At T3, patients with non-painful (n = 98) or painful neuropathy (n = 34) frequently reported symptoms in the fingers (non-painful = 83.5%, painful = 76.5%) or toes (non-painful = 49.5%, painful = 41.2%) and characterized symptoms as numbness (non-painful = 54.1%, painful = 50%) or tingling (non-painful = 68.4%, painful = 82.4%). Self-reported CIPN functional limitations (n = 55) included difficulties with buttoning a shirt (38.2%) or walking (25.5%). Paclitaxel-related CIPN (n = 33) was frequently characterized as "continuous" (30.3%), whereas oxaliplatin-related CIPN (n = 51) was frequently characterized as "intermittent" (41.2%). Young adults (15-39 years old, n = 15) frequently reported moderate-severe non-painful CIPN (46.7%), painful CIPN (40%), and CIPN interference (33.3%). CONCLUSIONS: Consistent with qualitative research, participants frequently described CIPN as numbness and/or tingling in the fingers and/or toes.

Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic.

With the rise in telehealth due to the COVID-19 pandemic, further research is needed to determine how to optimize virtual delivery of existing integrative oncology interventions for cancer treatment-related symptoms. The purpose of this qualitative analysis was to explore cancer survivors' perspectives of the acceptability and satisfaction of an 8-week, virtual yoga intervention for cancer survivors with chronic chemotherapy-induced peripheral neuropathy pain. Fourteen participants with chronic chemotherapy-induced peripheral neuropathy pain who completed the virtual yoga intervention were interviewed using a semistructured interview guide. Themes were derived from the data using inductive content analysis methods. Main findings from the interviews included the following: (1) participants were willing to try new nonpharmacological treatments for chemotherapy-induced peripheral neuropathy due to the high symptom burden and prior lack of success with medications; (2) participants highly rated the flexibility offered by the virtual format, but desired the social support potentially offered by practicing in-person yoga; and (3) the impact of virtual yoga on chemotherapy-induced peripheral neuropathy severity was unclear. There were several barriers to participants' use of virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain (eg, technology, lack of space/equipment). The results may be used to improve the design and delivery of future trials testing virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain.

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.

Exploring the impact of a decision support algorithm to improve clinicians' chemotherapy-induced peripheral neuropathy assessment and management practices: a two-phase, longitudinal study.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) negatively affects physical function and chemotherapy dosing, yet, clinicians infrequently document CIPN assessment and/or adhere to evidence-based CIPN management in practice. The primary aims of this two-phase, pre-posttest study were to explore the impact of a CIPN clinician decision support algorithm on clinicians' frequency of CIPN assessment documentation and adherence to evidence-based management. METHODS: One hundred sixty-two patients receiving neurotoxic chemotherapy (e.g., taxanes, platinums, or bortezomib) answered patient-reported outcome measures on CIPN severity and interference prior to three clinic visits at breast, gastrointestinal, or multiple myeloma outpatient clinics (n = 81 usual care phase [UCP], n = 81 algorithm phase [AP]). During the AP, study staff delivered a copy of the CIPN assessment and management algorithm to clinicians (N = 53) prior to each clinic visit. Changes in clinicians' CIPN assessment documentation (i.e., index of numbness, tingling, and/or CIPN pain documentation) and adherence to evidence-based management at the third clinic visit were compared between the AP and UCP using Pearson's chi-squared test. RESULTS: Clinicians' frequency of adherence to evidence-based CIPN management was higher in the AP (29/52 [56%]) than the UCP (20/46 [43%]), but the change was not statistically significant (p = 0.31). There were no improvements in clinicians' CIPN assessment frequency during the AP (assessment index = 0.5440) in comparison to during the UCP (assessment index = 0.6468). CONCLUSIONS: Implementation of a clinician-decision support algorithm did not significantly improve clinicians' CIPN assessment documentation or adherence to evidence-based management. Further research is needed to develop theory-based implementation interventions to bolster the frequency of CIPN assessment and use of evidence-based management strategies in practice. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03514680 . Registered 21 April 2018.

Perceived patient-centered communication, quality of life, and symptom burden in individuals with ovarian cancer.

OBJECTIVE: To describe perceptions of patient-centered communication (PCC); assess whether physician specialty, patient characteristics, or health system characteristics are associated with PCC; and identify associations between PCC, health-related quality of life (HRQoL), and symptom burden among individuals with ovarian cancer. METHODS: Cross-sectional, descriptive survey of English-speaking adults with ovarian cancer. PCC, HRQoL, and ovarian cancer symptom burden were assessed with the PCC-Ca-36, the FACT-G, and the FOSI-18, respectively. PCC-Ca-36 scores were summarized using descriptive statistics. Predictors of PCC-Ca-36, FACT-G, and FOSI-18 scores were identified using multiple linear regression. RESULTS: Participants (n = 176) had a mean age of 59.4 years (SD = 12.1). The majority (65.9%) had advanced-stage disease, while 42.0% were receiving treatment. The mean PCC-Ca-36 total score was 4.09 (SD = 0.78) out of a possible 5, indicating participants often perceived that clinicians engaged in PCC. Among the PCC functions, participants reported that clinicians least often enabled patient self-management (M = 3.65, SD = 0.99), responded to emotions (M = 3.84, SD = 1.04), and managed uncertainty (M = 3.91, SD = 0.93). In multivariable analyses, neither physician specialty nor patient and health system characteristics were significantly associated with overall PCC. Greater overall PCC predicted better overall HRQoL; better social/family, emotional, and functional well-being; and lower overall and physical symptom burden (all p ≤ 0.05). CONCLUSION: Greater PCC is significantly associated with better HRQoL and lower symptom burden among individuals with ovarian cancer. PRACTICE IMPLICATIONS: Promotion of PCC is a promising strategy to improve patient-reported outcomes in the ovarian cancer care setting.

Nurse-Led Motivational Interviewing for Setting Functional Cancer Pain Goals.

PURPOSE: Persons with advanced cancers experience high rates of pain. Nursing interventions for pain, which are tailored to the individual patient, may support motivation to engage in self-management and should include setting of realistic functional goals. For patients with advanced cancer, functional pain goals include personally important activities, measurable across clinical encounters. However, limited evidence exists regarding nursing assessment of functional pain goals. To address this gap, we piloted use of a motivational interviewing intervention. Motivational interviewing is a clinical technique for clarifying goals and related impediments, such as cognitive and emotional factors underlying pain management behaviors. DESIGN: Pilot feasibility testing. METHODS: Palliative care patients with cancer-related pain completed up to four intervention sessions, the Pain Self-Efficacy Questionnaire, and an author-developed acceptability questionnaire. Feasibility success was determined by 60% of participants completing at least two interventions. Fidelity to the intervention was assessed using the Motivational Interviewing Skills for Healthcare Encounters tool. RESULTS: Sixty-seven percent completed two interventions. Participants reported that interventions were helpful, worthwhile, and recommended. Mean pain self-efficacy scores (0-60 possible) rose from 31.5 (SD = 11.2) at intervention 1 to 35.5 (SD = 13) after intervention 4. Intervention fidelity was maintained. CONCLUSIONS: Participants were willing to engage in multiple motivational interviewing conversations focused on pain management behaviors related to functional goals. Based on these findings about motivational interviewing for functional goals and patient willingness to set them, these conversations may have a place in clinical care as an element of pain assessment and intervention tailoring.

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.

Threats of Bots and Other Bad Actors to Data Quality Following Research Participant Recruitment Through Social Media: Cross-Sectional Questionnaire.

BACKGROUND: Recruitment of health research participants through social media is becoming more common. In the United States, 80% of adults use at least one social media platform. Social media platforms may allow researchers to reach potential participants efficiently. However, online research methods may be associated with unique threats to sample validity and data integrity. Limited research has described issues of data quality and authenticity associated with the recruitment of health research participants through social media, and sources of low-quality and fraudulent data in this context are poorly understood. OBJECTIVE: The goal of the research was to describe and explain threats to sample validity and data integrity following recruitment of health research participants through social media and summarize recommended strategies to mitigate these threats. Our experience designing and implementing a research study using social media recruitment and online data collection serves as a case study. METHODS: Using published strategies to preserve data integrity, we recruited participants to complete an online survey through the social media platforms Twitter and Facebook. Participants were to receive $15 upon survey completion. Prior to manually issuing remuneration, we reviewed completed surveys for indicators of fraudulent or low-quality data. Indicators attributable to respondent error were labeled suspicious, while those suggesting misrepresentation were labeled fraudulent. We planned to remove cases with 1 fraudulent indicator or at least 3 suspicious indicators. RESULTS: Within 7 hours of survey activation, we received 271 completed surveys. We classified 94.5% (256/271) of cases as fraudulent and 5.5% (15/271) as suspicious. In total, 86.7% (235/271) provided inconsistent responses to verifiable items and 16.2% (44/271) exhibited evidence of bot automation. Of the fraudulent cases, 53.9% (138/256) provided a duplicate or unusual response to one or more open-ended items and 52.0% (133/256) exhibited evidence of inattention. CONCLUSIONS: Research findings from several disciplines suggest studies in which research participants are recruited through social media are susceptible to data quality issues. Opportunistic individuals who use virtual private servers to fraudulently complete research surveys for profit may contribute to low-quality data. Strategies to preserve data integrity following research participant recruitment through social media are limited. Development and testing of novel strategies to prevent and detect fraud is a research priority.

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation.

For women who are unaffected carriers of a pathogenic BRCA mutation, cancer risk management requires ongoing education, counseling, and support from an interdisciplinary team of medical specialists, genetic counselors, and nurses specializing in genomics. The purpose of this study was to develop and pilot test an educational, patient-focused decision aid to facilitate shared decision making. A steering committee developed the prototype aid after an extensive review of the literature. The aid was designed at the ninth-grade reading level, to be consistent with internationally accepted clinical guidelines and inclusive of all risk management options and psychosocial issues important to cancer risk management decision making. The aid was tested with 23 participants: eight experts and 15 end users. Eleven survey items were asked related to organization, clarity, usefulness, comprehensiveness, ease of understanding, and relevance to the cancer risk management decision-making process. Mean scores were 3 or higher on Likert scales of 1-4 (high) for each of the 11 items. Two open-ended questions elicited general comments and suggestions for additions, deletions, or revisions to the decision aid. The steering committee made final revisions to the aid based on participant feedback and committee consensus.

Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Item response theory analysis and properties of decisional conflict scales: findings from two multi-site trials of men with localized prostate cancer.

BACKGROUND: Decisional conflict is associated with decision quality and may affect decision outcomes. In the health sciences literature, the Decisional Conflict Scale is widely used to measure decisional conflict, yet limited research has described the psychometric properties of the Decisional Conflict Scale subscales and of the low literacy version of the scale. The purpose of this secondary data analysis was therefore to examine properties of the original (DCS-12) and low literacy (LL DCS-10) Decisional Conflict Scales using Classical Measurement Theory and Item Response Theory. METHODS: Data from two multi-site trials of men with prostate cancer were used to analyze the DCS-12, LL DCS-10, and an aggregated DCS-12 dataset in which five response options were aggregated into three. Internal consistency was estimated with Cronbach's alphas. Subscale correlations were evaluated with Pearson's correlation coefficient. Item difficulty, item discrimination, and test information were evaluated using Graded Response Modeling (GRM). The likelihood ratio test guided model selection. RESULTS: Cronbach's alphas for the total scales and three of four subscales were ≥ 0.85. Alphas ranged from 0.34-0.57 for the support subscales. Subscale correlations ranged from 0.42-0.71 (P < 0.001). Items on the DCS-12 exhibited the widest range of difficulty. Two items on the support subscale had low to moderate discrimination and contributed little information. Only the DCS-12 was informative across the full range of decisional conflict values. CONCLUSIONS: Lack of precision in the support subscale raises concerns about subscale validity. The DCS-12 is most capable of discriminating between respondents with high and low decisional conflict. Evaluation of interventions to reduce decisional conflict must consider the above findings.