'A good decision is the one that feels right for me': Codesign with patients to inform theoretical underpinning of a decision aid website.

INTRODUCTION: Patient decision aids (PtDA) complement shared decision-making with healthcare professionals and improve decision quality. However, PtDA often lack theoretical underpinning. We are codesigning a PtDA to help people with increased genetic cancer risks manage choices. The aim of an innovative workshop described here was to engage with the people who will use the PtDA regarding the theoretical underpinning and logic model outlining our hypothesis of how the PtDA would lead to more informed decision-making. METHODS: Short presentations about psychological and behavioural theories by an expert were interspersed with facilitated, small-group discussions led by patients. Patients were asked what is important to them when they make health decisions, what theoretical constructs are most meaningful and how this should be applied to codesign of a PtDA. An artist created a visual summary. Notes from patient discussions and the artwork were analysed using reflexive thematic analysis. RESULTS: The overarching theme was: It's personal. Contextual factors important for decision-making were varied and changed over time. There was no one 'best fit' theory to target support needs in a PtDA, suggesting an inductive, flexible framework approach to programme theory would be most effective. The PtDA logic model was revised based on patient feedback. CONCLUSION: Meaningful codesign of PtDA including discussions about the theoretical mechanisms through which they support decision-making has the potential to lead to improved patient care through understanding the intricately personal nature of health decisions, and tailoring content and format for holistic care. PATIENT CONTRIBUTION: Patients with lived experience were involved in codesign and coproduction of this workshop and analysis as partners and coauthors. Patient discussions were the primary data source. Facilitators provided a semi-structured guide, but they did not influence the patient discussions or provide clinical advice. The premise of this workshop was to prioritise the importance of patient lived experience: to listen, learn, then reflect together to understand and propose ideas to improve patient care through codesign of a PtDA.

Psychological distress in pulmonary embolism survivors in a pulmonary embolism response team clinic: Protocol for a prospective observational study.

Background: Pulmonary embolism (PE) is a leading cause of cardiovascular death. Psychological distress in PE is understudied and underrecognized. Objectives: The primary aim of this proposed protocol was to describe the incidence of psychological distress symptoms (anxiety, depression, posttraumatic stress, and fear of recurrence) in the survivors of PE after discharge from hospitalization. The secondary aim was to assess the influence of acute disease, etiology, and treatment of PE on psychological distress. Methods: This is a prospective observational cohort study in a large tertiary care referral center. The participants are adult patients presenting to the hospital with PE fulfilling objective pulmonary embolism response team (PERT) activation criteria. After discharge, patients complete a series of validated measures of psychological distress (anxiety, depression, posttraumatic stress, and fear of recurrence) and quality of life at follow-ups approximately 1, 3, 6, and 12 months after diagnosis and treatment of their PE. Factors influencing each type of distress are evaluated. Conclusion: This protocol aims to identify the unmet needs of patients experiencing psychological distress following PE. It will describe anxiety, depression, fear of recurrence, and posttraumatic symptoms in PE survivors during the first year of outpatient follow-up in a PERT clinic.

Comprehensive Care of Women With Genetic Predisposition to Breast and Ovarian Cancer.

Women at risk for hereditary breast and ovarian cancer syndromes are frequently seen in primary care and gynecology clinics. They present with a distinctive set of clinical and emotional needs that revolve around complex risk management discussions and decision making. The care of these women calls for the creation of individualized care plans that facilitate adjustment to the mental and physical changes associated with their choices. This article provides an update on comprehensive evidence-driven care of women with hereditary breast and ovarian cancer. The aim of this review is to aid clinicians in identifying those at risk for hereditary cancer syndromes and provide practical advice on patient-centered medical and surgical risk management. Topics of discussion include enhanced surveillance, preventive medications, risk-reducing mastectomy and reconstruction, risk-reducing bilateral salpingo-oophorectomy, fertility, sexuality, and menopausal management, with attention to the importance of psychological support. High-risk patients may benefit from a multidisciplinary team that provides realistic expectations with consistent messaging. The primary care provider must be aware of the special needs of these patients and the consequences of their risk management interventions.

Valued Outcomes in the Cancer Experience (VOICE)™: Development and validation of a multidimensional measure of perceived control.

OBJECTIVE: Enhancing cancer patients' sense of control can positively impact psychological well-being. We developed and assessed the psychometric properties of Valued Outcomes in the Cancer Experience (VOICE)TM, a measure of patients' perceived control over key personal priorities within their cancer experience. METHODS: VOICE construction and testing were completed in three phases with separate participant samples: (1) item generation and initial item pool testing (N = 459), (2) scale refinement (N = 623), and (3) confirmatory validation (N = 515). RESULTS: A 21-item measure was developed that captures cancer patients' sense of control in seven key domains: (1) Purpose and Meaning, (2) Functional Capacity, (3) Longevity, (4) Quality Care, (5) Illness Knowledge, (6) Social Support, and (7) Financial Capability. VOICE demonstrated adequate internal consistency (full-scale α = 0.93; factor α = 0.67-0.89) and adequate to strong convergent and discriminatory validity. SIGNIFICANCE OF RESULTS: VOICE measures cancer patients' perceived control across a diverse range of personal priorities, creating a platform for elevating patient perspectives and identifying pathways to enhance patient well-being. VOICE is positioned to guide understanding of the patient experience and aid the development and evaluation of supportive care interventions to enhance well-being.

Cross-sectional clinical cancer genomics community of practice survey analysis of provider attitudes and beliefs regarding the use of deceased family member tissue to guide living family member genetic cancer risk assessment.

Next-generation tumor tissue sequencing techniques may result in the detection of putative germline pathogenic variants (PVs), raising the possibility that germline cancer predisposition could be identified from archival medical tissue samples of deceased relatives. The approach, termed traceback, is designed to inform risk management recommendations for living family members. Provider perspectives regarding traceback testing have not yet been explored, so we conducted a cross-sectional survey of Clinical Cancer Genomics Community of Practice providers regarding their attitudes and beliefs toward traceback testing. Self-reported demographics, provider characteristics, attitudes and perceived barriers were collected. We evaluated responses in the context of whether providers had previous experience with traceback testing. Data were analyzed using chi-square and Fisher's exact testing. Among 207 respondents (of 816 eligible), most were women (89.4%), white (85.5%), and not Hispanic or Latino (89.7%). US-based providers represented the majority of respondents (87.4%). Relatively, few providers 32 of 207 (15.5%) had previous experience with traceback. Among the individuals without experience in traceback, 84.0% thought there would be barriers to implementation; however, only 68.8% of individuals with previous traceback experience agreed (p = .04). Respondents in both groups thought that traceback would be valuable in their practice (82.6%, p = .22) and that they would feel comfortable discussing the concept (83.6%, p = .83), interpreting the results (72.2%, p = .24), and discussing the results with their patients (80.7%, p = .38). Patient interest and cost were seen as less of a barrier by those with experience with traceback testing. Recurrent themes obtained in open-ended responses are also presented. Overall, providers believe that traceback would be a valuable tool in their practice. Individuals with previous experience identified less barriers with implementation of this testing, highlighting an area for future research and education.

Chemoprevention Considerations in Patients with Hereditary Colorectal Cancer Syndromes.

Secondary prevention of colorectal neoplasia with chemoprevention is long-studied area of research and clinical use in patients with the 2 most common hereditary colorectal cancer syndromes including Lynch syndrome and familial adenomatous polyposis. No medication is currently approved for use for the prevention of colorectal polyps or cancer in either the general population or individuals with the hereditary colorectal cancer syndromes. Emerging data in animal models and limited data in humans suggest vaccines may be the next breakthrough for neoplasia prevention in patients with hereditary colorectal cancer. Clinicians must acknowledge chemoprevention is an adjunct and does not supplant endoscopic surveillance.

ACG Clinical Report and Recommendations on Transition of Care in Children and Adolescents With Hereditary Polyposis Syndromes.

Transition of care (TOC) in adolescents and young adults (AYAs) with chronic gastrointestinal disorders has received increased attention, especially in those with inflammatory bowel disease. AYAs with hereditary polyposis syndromes are a heterogeneous group of patients with overlapping and complex medical needs. These patients are particularly vulnerable because of the risk of loss of continuity of care and subsequent poor disease outcomes. The Pediatric Committee of the American College of Gastroenterology commissioned a report with recommendations on TOC in AYAs with hereditary polyposis syndromes. This report aims at achieving best practice by both pediatric and adult gastroenterologists despite the paucity of published evidence in this population reflected in the included PRISMA report. Therefore, the group extrapolated findings from the literature related to other chronic gastrointestinal disorders, and a high degree of expert consensus was scored for all recommendations. The report addresses TOC through identifying shared domains followed by specific recommendations in disease management, including models of care, providers and patient and socioeconomic factors relevant to TOC. Areas of strong emphasis include the need for early planning, flexibility in the transition process to maintain continuity during major surgical procedures, patient and family psychological readiness, liaison among team members addressing transition, and changing insurance coverage in this population.

Using chatbots to screen for heritable cancer syndromes in patients undergoing routine colonoscopy.

BACKGROUND: Hereditary colorectal cancer (HCRC) syndromes account for 10% of colorectal cancers but remain underdiagnosed. This feasibility project tested the utility of an artificial intelligence-based chatbot deployed to patients scheduled for colonoscopy to identify HCRC risk factors, educate participants about HCRC and obtain consent to genetic testing as an extension of genetic counselling of appropriate subjects. Genetic counsellor (GC) and genetic counselling assistant (GCA) time spent per subject was also measured. METHODS: Patients scheduled for colonoscopy at Cleveland Clinic were invited via electronic medical record patient portal or letter prior to colonoscopy with a link to a chatbot administering the Colon Cancer Risk Assessment Tool (CCRAT) to screen for HCRC syndromes. Those with ≥1 positive response to a CCRAT question received chatbot-deployed genetic education and the option to receive genetic testing. An order for a 55-gene pan-cancer panel was placed for those consenting, and the subject had blood drawn on the day of colonoscopy. Results were disclosed by a GC or GCA by telephone. Subject demographics, progression through the chat, responses to CCRAT, personal and family history, genetic test results and communication with the subject were recorded. Descriptive statistics and two-tailed unpaired t-test and Fisher's exact test were used. RESULTS: 506/4254 (11.9%) initiated and 487 (96.2%) completed the chat with the chatbot. 215 (44.1%) answered 'yes' to ≥1 CCRAT question and all completed pretest education. 129/181 (71.3%) subjects who consented completed testing, and 12 (9.3%) were found to have a germline pathogenic variant. Per subject, the GC spent a mean of 14.3 (SD 7.3) and the GCA a mean of 19.2 (SD 9.8) minutes. CONCLUSION: The use of a chatbot in this setting was a novel and feasible method, with the potential of increasing genetic screening and testing in individuals at risk of HCRC syndromes.

From Tear to Fear: Posttraumatic Stress Disorder in Patients With Acute Type A Aortic Dissection.

Background Acute type A aortic dissection presents with abrupt onset of pain that requires emergency surgery. However, minimal research exists on posttraumatic stress disorder (PTSD) in survivors. We aimed to quantify the prevalence and describe characteristics of PTSD in patients following dissection. Methods and Results A total of 295 adult survivors of surgical dissection with an email on file were administered a cross-sectional online survey about their dissection experience; 137 returned questionnaires, and 129 (94%) responded to the 4-item Primary Care PTSD portion of the survey that was part of a larger lifestyle survey designed to study survivors of aortic dissection and surgery. In addition to the PTSD screening, it inquired about current sexual activity, exercise habits, and employment within the preceding 30 days. At a median of 6.8 years (quartile 1=2.6, quartile 3=8.9 years) after dissection, 23% of patients (30/129) screened positive for PTSD, with 44% (57/129) stating that within the past month they felt constantly on guard or watchful or were easily startled. Of those who screened positive and matched to their electronic medical record (n=27), only 2 (7.4%) had been tested and clinically diagnosed with PTSD. Patients who screened positive for PTSD were more likely to report limited current sexual activity than those who did not (odds ratio, 5.3; 95% CI, 1.9-15 [P=0.0006]). Conclusions PTSD is an important mental health consideration in aortic dissection survivors. Physicians should screen these patients for PTSD at follow-up visits to identify those who test positive and refer them for further testing and treatment, such as trauma-focused psychotherapy or medication.

Experience Gained from the Development and Execution of a Multidisciplinary Multi-syndrome Hereditary Colon Cancer Family Conference.

Genetic healthcare professionals provide genetic cancer risk assessment and follow-up care for patients facing hereditary cancers. To meet the needs of those affected by hereditary colorectal cancer, City of Hope and the Hereditary Colon Cancer Foundation collaborated to develop a "Family Day" conference. We describe the development of our conference based upon the Hereditary Colon Cancer Foundation's "Family Day" program model, with refinements completed using the Participatory Action Research theoretical framework, which incorporated input from conference participants and researchers. Thirty-one participants attended the conference, representing patients with, or families, friends, and caregivers of those with, multiple colorectal cancer predisposition syndromes, including Lynch, familial adenomatous polyposis, and juvenile polyposis. Participants who completed the feedback surveys (n = 22) were highly satisfied with the presentation content, ranking the keynote lecture on family communication the highest of the conference events. Participants also provided feedback regarding how to improve future conferences. In conclusion, we share our experience and provide guidance for developing a successful hereditary colon cancer predisposition patient and family conference.

Traceback: A Proposed Framework to Increase Identification and Genetic Counseling of BRCA1 and BRCA2 Mutation Carriers Through Family-Based Outreach.

In May 2016, the Division of Cancer Prevention and the Division of Cancer Control and Population Sciences, National Cancer Institute, convened a workshop to discuss a conceptual framework for identifying and genetically testing previously diagnosed but unreferred patients with ovarian cancer and other unrecognized BRCA1 or BRCA2 mutation carriers to improve the detection of families at risk for breast or ovarian cancer. The concept, designated Traceback, was prompted by the recognition that although BRCA1 and BRCA2 mutations are frequent in women with ovarian cancer, many such women have not been tested, especially if their diagnosis predated changes in testing guidelines. The failure to identify mutation carriers among probands represents a lost opportunity to prevent cancer in unsuspecting relatives through risk-reduction intervention in mutation carriers and to provide appropriate reassurances to noncarriers. The Traceback program could provide an important opportunity to reach families from racial, ethnic, and socioeconomic groups who historically have not sought or been offered genetic counseling and testing and thereby contribute to a reduction in health disparities in women with germline BRCA mutations. To achieve an interdisciplinary perspective, the workshop assembled international experts in genetics, medical and gynecologic oncology, clinical psychology, epidemiology, genomics, cost-effectiveness modeling, pathology, bioethics, and patient advocacy to identify factors to consider when undertaking a Traceback program. This report highlights the workshop deliberations with the goal of stimulating research and providing a framework for pilot studies to assess the feasibility and ethical and logistical considerations related to the development of best practices for implementation of Traceback studies.

Exploration of Male Attitudes on Partnerships and Sexuality with Female BRCA1/2 Mutation Carriers.

Women with BRCA mutations are inundated with decisions about managing cancer risks and childbearing considerations. Decisions become more complicated when women face disclosing their mutation and risk-reduction options to a romantic partner. This study identifies the concerns and perspectives of male romantic partners regarding these unique decisions. Twenty-five male participants completed an online survey posted to cancer support group message boards. Participants reported relationship changes regarding intimacy levels (n = 9), attraction (n = 2), and communication (n = 22) after mutation disclosure. Participants whose partners had not undergone prophylactic mastectomy (n = 14) reported concerns regarding sexual relations (n = 5), post-surgical appearance (n = 2), post-surgical attraction (n = 5), and health/lifespan (n = 9). Participants did not express attitude changes toward childbearing. While mutation disclosure conversations and surgical options are concerns for many BRCA mutation carriers in relationships, male partners share these concerns. Aspects of the relationship may change, but male study participants continued to support their partners. This information can benefit female BRCA mutation carriers, their current or future partners, and genetic counselors working with this particular population.

Psychosocial Health Outcomes for Family Caregivers Following the First Year of Bereavement.

The authors examined psychosocial outcomes following the first year of bereavement, for 51 family caregivers, including both spouses and offspring. Researchers assessed caregivers during palliative care and again during the second year of bereavement, for social functioning, depression, and distress. For all family caregivers, only depression scores declined significantly between T1 and T2 (p < 0.05). Caregiver relationship and gender did not make a difference in recovery. Results demonstrate that poor psychosocial health outcomes exist beyond the first year of bereavement. Early identification of these caregivers is necessary to provide mental health professionals the opportunity to intervene proactively.

Toward a model of continuous care: A necessity for caregiving partners.

OBJECTIVE: Caregiving partners constitute a unique group, who provide both physical and emotional care for patients. There has been extensive research conducted on caregivers during either the caregiving or bereavement phase; however, these phases are often treated as separate entities rather than as part of a continuum. METHOD: In this paper, utilizing relevant literature and clinical observations, we map the emotional journey and lived experience of caregivers moving from disease progression, to the end of life, to the dying process itself, and then through life after the death of a partner. Along this journey, we identify the links between pre-death caregiving and bereavement. RESULTS: Our illustration raises awareness regarding the unmet needs experienced by caregiving partners across the continuum and provides an alternative framework through which clinicians can view this course. SIGNIFICANCE: of Results We bolster arguments for improved palliative care services and early interventions with distressed caregiving partners by emphasizing continuity of care both before and after a patient's death.

'The BRCA clock is ticking!': negotiating medical concerns and reproductive goals in preimplantation genetic diagnosis.

Despite research on BRCA1/2 mutation carriers attitudes towards preimplantation genetic diagnosis (PGD), considerably less is known about individuals' experience with its use. Through case reports of BRCA1/2 mutation carriers' thoughts on, and use of, PGD, this paper highlights how the option of PGD is experienced and negotiated in the context of reproductive and life-course goals. Drawing on qualitative interviews with 38 BRCA1/2 mutation carriers, this article focuses on a subsample of 10 interviewees who sought consultation for, and/or attempted, PGD, with in-depth reports of 3 cases and summary decisions of the remaining 7. Three couples decided against PGD, and one was deciding at the time of the interview. Interviewees discuss key aspects of their experience prior to, and going through, PGD for BRCA1/2, including potential challenges of becoming pregnant through PGD and of heightened pressure to achieve their reproductive goals more quickly. Despite considerable focus on ethical issues in screening embryos for mutations associated with adult-onset cancer risk, less attention has been paid to the technical, logistical, and related psychosocial issues. Narrative case reports may help individuals develop appropriate expectations of PGD for BRCA prepare for possibly challenging decisions and outcomes, and ultimately determine whether it is compatible with their reproductive goals.

Talking about familial breast cancer risk: topics and strategies to enhance mother-daughter interactions.

A hereditary cancer predisposition can rattle families, creating dysfunctional interactions. Families need assistance navigating conversations about risk. Because mothers and daughters uniquely share breast cancer experiences and risk, there is a particular need for practitioners to assist them with communication. Three focus groups were conducted with 11 mothers with an elevated cancer risk (with adolescent daughters) receiving genetic counseling. We explored three inquiries to capture mother-daughter communication: emergent challenging topics (e.g., health-promotion behavior, daughter's risk, mother's risk of death), factors complicating discussions (e.g., balancing what to share and when, guilt and blaming, confusion about risk and prevention), and strategies enhancing conversations initiated by mothers (e.g., paying attention to daughter's cues) or practitioners (e.g., inviting daughters to appointments). Findings suggested that mothers struggle to balance eliciting daughters' concerns, providing them with support, and imparting knowledge without overwhelming them. We offer mothers and practitioners guidance to help facilitate these conversations.

Chest and upper body morbidity following immediate postmastectomy breast reconstruction.

OBJECTIVE: The performance of a mastectomy for the treatment or prophylaxis of breast cancer may have long-term implications for both physical and mental well-being in women. The development of breast numbness and phantom breast sensations following mastectomy is well-known; however, relatively little is known about physical morbidity following postmastectomy breast reconstruction. The primary objective of this study was to evaluate the level of physical morbidity experienced following three surgical approaches: mastectomy alone, postmastectomy tissue expander/implant reconstruction, and postmastectomy autogenous tissue reconstruction. METHODS: We conducted a cross-sectional survey of a sample of women who had undergone mastectomy with or without reconstruction. Chest and upper body morbidity were evaluated using the BREAST-Q. Physical well-being was compared across three types of breast surgery. RESULTS: In total, 308 of 452 women who received a questionnaire booklet returned completed questionnaires. There was an overall difference in physical morbidity attributable to surgical treatment (P < 0.001). Patients who underwent autogenous tissue reconstruction had the highest (i.e., best) mean physical well-being score. Women who underwent expander/implant reconstruction also had less chronic physical morbidity than women who underwent mastectomy alone (P < 0.05). CONCLUSIONS: Our findings suggest that women who undergo immediate autogenous tissue reconstruction experience significantly less chest and upper body morbidity than those who undergo either mastectomy with implant-based reconstruction or mastectomy alone. This information can be used to facilitate clinical decision-making, to validate individual experiences of breast cancer survivors, and to inform future innovations to decrease the long-term physical morbidity associated with breast cancer surgery.

A prospective study of quality of life in patients undergoing pelvic exenteration: interim results.

OBJECTIVE: Little prospective data exist on quality of life (QOL) after pelvic exenteration (PE). This ongoing study prospectively examines the QOL changes following this radical procedure using a comprehensive battery of psychological instruments. METHODS: Since 2005, enrolled patients were interviewed (EORTC QLQ-C30, EORTC QLQ-CR38, EORTC QLQ-BLM30, BFI, BPI-SF, IADL, CES-D, IES-R) preoperatively and at 3, 6, and 12 months after PE for physical/psychological symptoms. Data were examined using repeated measure ANOVA. RESULTS: Sixteen women (3 anterior, 1 posterior, and 12 total PEs), with more than 1 year of follow-up, completed all scheduled interviews. Median age was 58 years (range, 28-76 years). Overall QOL (F = 6.3, p < 0.02), ability to perform instrumental daily activities (F = 6.8, p < 0.02), body image (F = 11.9, p < 0.00), and sexual function (F = 8.0, p < 0.01) all declined at 3 months but were near baseline by 12 months after PE. Although, overall, physical function followed a similar trend (F = 14.8, p < 0.00), it did not return to baseline. At the 12-month interview, patients reported increased gastrointestinal symptoms (F = 8.9, p < 0.01) but significantly less stress-related ideation (F = 6.1, p < 0.03) compared to baseline. Pain levels did not change significantly during the study period (F = 0.4, p < 0.74). CONCLUSIONS: Although patients report lingering gastrointestinal symptoms and some persistent decline in physical function after PE, most adjust well, returning to almost baseline functioning within a year. Providers can counsel patients that many, though not all, symptoms in the first 3 months following exenteration are likely to improve as they adapt to their changed health status. These preliminary results await confirmation of a larger analysis.

Development and preliminary evaluation of a training workshop for the collection of patient-reported outcome (PRO) interview data by research support staff.

This paper describes the development and initial evaluation of a didactic curriculum to prepare research support staff with the core knowledge and skills required to collect patient-reported outcomes (PROs) via interviews. Research support staff members (N = 77) were recruited for eight separate workshops, each consisting of a didactic presentation followed by role-play scenarios with trained actors depicting common scenarios they may encounter as part of patient interaction. Trainees were observed and received feedback on their performance from trained facilitators and peers. In comparison to their pre-training assessment, trainees showed significant improvement in their confidence to conduct a research interview, handle a distressed participant, manage a wandering interview, ask participants sensitive questions, and handle irritated patients. Training research support staff in the effective collection of PROs via patient interviews can improve the confidence of these individuals in interacting with patients, which can ultimately lead to increased accuracy of data collection.