Academic Physician Specialists' Approaches to Counseling Patients Interested in Unproven Stem Cell and Regenerative Therapies-A Qualitative Analysis.

OBJECTIVE: To explore the experiences, approaches, and challenges of physicians consulting patients about experimental stem cell and regenerative medicine interventions (SCRIs). PARTICIPANTS AND METHODS: From August 21, 2018, through July 30, 2019, semistructured interviews of 25 specialists in cardiology, ophthalmology, orthopedics, pulmonology, and neurology were conducted and qualitatively analyzed using modified grounded theory. RESULTS: All specialists used informational approaches to counsel patients, especially orthopedists. Informational approaches included explaining stem cell science, sharing risks, and providing principles. Several specialists also used relational counseling approaches including emphasizing that physicians want what is best for patients, acknowledging suffering, reassuring continued care, empathizing with patients and families, and underscoring that patients have the final decision. Many specialists reported being comfortable with the conversation, although some were less comfortable and several noted challenges in the consultation including wanting to support a patient's decision but worrying about harms from unproven SCRIs, navigating family pressure, and addressing stem cell hype and unrealistic expectations. Specialists also desired that additional resources be available for them and patients. CONCLUSION: Physicians relied more heavily on providing patients with information about SCRIs than using relational counseling approaches. Efforts should be directed at helping physicians address the informational and relational needs of patients, including providing tools and resources that inform physicians about the unproven SCRI industry, building skills in empathic communication, and the creation and dissemination of evidence-based resources to offer patients.

PERSPECTIVES: Stroke survivors' views on the design of an early-phase cell therapy trial for patients with chronic ischaemic stroke.

BACKGROUND: Stem cell research holds the potential for a paradigm shift in the management of diseases such as stroke. Patient and public involvement in research (PPIR) can bring a focus to issues of clinical relevance and accelerate translation to real-world clinical practice. OBJECTIVE: A qualitative thematic analysis of the perspectives of stroke survivors regarding the conduct and design aspects of a proposed phase I clinical cell therapy study in stroke. DESIGN: Twelve stroke survivors were purposively recruited in July 2016-August 2017 and participated in semi-structured, face-to-face interviews for input into the design of a proposed phase I clinical study of autologous dental pulp stem cells. Concurrent thematic analysis was conducted until data saturation was achieved. DISCUSSION AND CONCLUSIONS: Participants conveyed that the most relevant outcomes to them were regaining participation, decreased dependence on caregivers and improvement in cognition, memory, mood, pain and fatigue. The perception of risk vs. benefit was likely influenced by the time elapsed since stroke, with participants being more willing to accept a higher level of risk early in the post-stroke disease course. They believed that all stroke survivors should be given an opportunity to participate in research, irrespective of their cognitive capacity. A relatively small sample population of 12 stroke survivors was studied as thematic saturation was achieved. PERSPECTIVES study applied principles of PPIR to early-phase cell research. Incorporation of outcomes relevant to patients' need within the study design is critical to generate data that will enable personalized application of regenerative medicine in stroke.

Stakeholder views and attitudes towards prenatal and postnatal transplantation of fetal mesenchymal stem cells to treat Osteogenesis Imperfecta.

The Boost Brittle Bones Before Birth (BOOSTB4) clinical trial is investigating the safety and efficacy of transplanting fetal derived mesenchymal stromal cells (MSCs) prenatally and/or in early postnatal life to treat severe Osteogenesis Imperfecta (OI). This study aimed to explore stakeholder views to understand perceived benefits or concerns, identify ethical issues and establish protocols for support and counselling. Semi-structured qualitative interviews were conducted with three groups; 1. Adults affected with OI, with and without children, and parents of children affected with OI; 2. Health professionals who work with patients with OI; 3. Patient advocates from relevant patient support groups. Interviews were digitally recorded, transcribed verbatim and analysed using thematic analysis. Interviews with 56 participants revealed generally positive views towards using fetal MSC transplantation to treat OI. Early treatment was considered advantageous for preventing fractures and reducing severity and could bring psychological benefits for parents. Common concerns were procedure safety, short/long-term side effects and whether transplantation would be effective. Difficulties inherent in decision-making were frequently discussed, as treatment efficacy is unknown and, by necessity, parents will make decisions at a time when they are vulnerable. Support needs may differ where there is a family history of OI compared to an unexpected diagnosis of OI. Explaining fetal MSC transplantation in a way that all parents can understand, clear expectation setting, psychological support and time for reflection during the decision-making process will be crucial to allow parents to make informed decisions about participation in the BOOSTB4 clinical trial.

Resilience, trust, and civic engagement in the post-CCSVI era.

BACKGROUND: Scientific and financial investments in chronic cerebrospinal venous insufficiency (CCSVI) research have been made to address both the hope for and scepticism over this interventional strategy for MS. Despite limited evidence in support of the CCSVI hypothesis, the funding of clinical research was responsive to a demand by the public rarely seen in the history of medicine. We characterize patient perspectives about the CCSVI research trajectory, with particular attention to its impact on other non-pharmaceutical areas of MS research with a focus on stem cell interventions. METHODS: Semi-structured interviews with 20 MS patients across Canada who did not have CCSVI interventions. Interviews were analysed for recurring themes and individual variations using the constant comparative approach. RESULTS: Participants had a critical view of the divestment of funds from longstanding research to support CCSVI trials. They retain a sense of optimism, however, about emerging evidence for stem cell interventions for MS, and highlight the need for greater caution and conscientious communication of advances in medicine and science. CONCLUSIONS: The unrealized hopes for CCSVI challenged but did not undermine the resilience of patient communities. The narrative that unfolded highlights the importance of drawing a socially-minded space for public participation in science.

Longitudinal examination of family efficacy following pediatric stem cell transplant.

OBJECTIVE: Pediatric stem cell transplant (pSCT) is emotionally demanding for families. Yet, we know little of how the family unit responds to the adversity of pSCT within the first year after transplant. Family efficacy, an indicator of family resilience, is linked to positive parent, child, and family adjustment. Better understanding the factors that promote family efficacy during this difficult time could inform modifiable intervention targets and improve child and parent adjustment. The primary objectives were to examine patterns of family efficacy beliefs and identify factors that promote or hinder family efficacy. METHODS: Ninety caregivers (71% white, 7% black, 3% Hispanic, 4% Asian, 14% multiple ethnicities) of children receiving pSCT completed demographic forms, the Psychosocial Assessment Tool, and the Filial Parental and Collective Family Efficacy Beliefs scale prior to the family's discharge, and 1, 3, 6, and 9 months post-discharge. Latent growth curve modeling was used to examine family efficacy across time. Parent, child, and sibling distress, social support, and demographic factors served as predictors. RESULTS: Latent growth curve modeling demonstrated that family efficacy was stable for 9 months post pSCT discharge. Social support was positively related to family efficacy beliefs. No other variables predicted family efficacy. CONCLUSION: Most families perceive themselves as resilient following pSCT. Social relationships and support are critical in maintaining a family's sense of efficacy during the arduous pSCT course.

Follow the Yellow Brick Road: Self-management by Adolescents and Young Adults After a Stem Cell Transplant.

BACKGROUND: Stem cell transplant (SCT) is a major life event that can have long-term psychosocial consequences for the entire family. It is unknown the degree to which the psychosocial characteristics associated with SCT influence self-management behaviors and health outcomes in adolescents and young adults (AYAs). OBJECTIVE: The study had the following aims: (1) to describe how AYAs manage their care regimen post-SCT and (2) to explore self-management facilitators, barriers, processes, and behaviors within individual, family, community, and healthcare system domains. INTERVENTIONS/METHODS: A grounded theory study was conducted to understand the process AYAs use to manage their care after SCT. Semistructured individual interviews were conducted, digitally recorded, and transcribed verbatim. Data were coded to consensus and analyzed using constant comparison methods. RESULTS: A sample of 17 AYAs (13-25 years old at transplant) and 13 caregivers (dyads) participated in the study. Initially, the participants experienced a tornado of activities, information, and emotions. Support from family, friends, and healthcare providers empowered families to manage their care, maintain a positive attitude, and approach a "normal" life. CONCLUSIONS: Monotony, managing symptoms, and isolation were the hardest obstacles for AYAs throughout the process. Families discussed managing their care activities by developing routines that got easier with time. IMPLICATIONS FOR PRACTICE: Nurses play an instrumental role in AYA self-management practices by providing information, education, and social support. Psychosocial issues were prominent in the self-management process and should be addressed in future research and interventions with AYAs and caregivers.

Hormonal Changes and Sexual Dysfunction.

Sexual dysfunction is a common concern for many patients with cancer after treatment. Hormonal changes as a result of cancer-directed therapy can affect both male and female sexual health. This has the potential to significantly impact patients' quality of life, but is underreported and undertreated in the oncology setting. This review discusses commonly reported sexual issues and the role that hormonal changes play in this dysfunction. Although medical and psychosocial intervention strategies exist, there is a clear need for further research to formally develop programming that can assist people whose sexual health has been impacted by cancer treatment.

Stories and Music for Adolescent/Young Adult Resilience During Transplant Partnerships: Strategies to Support Academic-Clinical Nurse Collaborations in Behavioral Intervention Studies.

Evidence-based nursing is in the forefront of healthcare delivery systems. Federal and state agencies, academic institutions, and healthcare delivery systems recognize the importance of nursing research. This article describes the mechanisms that facilitate nursing partnerships yielding high-level research outcomes in a clinical setting. A phase-II multicenter behavioral intervention study with pediatric stem cell transplant patients was the context of this academic/clinical research partnership. Strategies to develop and maintain this partnership involved a thorough understanding of each nurse's focus and barriers. A variety of communication plans and training events maximized preexisting professional networks. Academic/clinical nurses' discussions identified barriers to the research process, the most significant being role conflict. Communication and validation of benefits to each individual and institution facilitated the research process during challenging times. Establishing strong academic/clinical partnerships should lead to evidence-based research outcomes for the nursing profession, healthcare delivery systems, and patients and families.

Personal resilience resources predict post-stem cell transplant cancer survivors' psychological outcomes through reductions in depressive symptoms and meaning-making.

This longitudinal study examined whether post-transplant cancer survivors (N = 254, 9 months to 3 years after stem cell transplant treatment) with greater personal resilience resources demonstrated better psychological outcomes and whether this could be attributed to reductions in depressive symptoms and/or four meaning-making processes (searching for and finding reasons for one's illness; searching for and finding benefit from illness). Hierarchical linear regression analyses examined associations of survivors' baseline personal resilience resources (composite variable of self-esteem, mastery, and optimism), which occurred an average of 1.7 years after transplant, and 4-month changes in psychological outcomes highly relevant to recovering from this difficult and potentially traumatic treatment: post-traumatic stress disorder (PTSD) symptoms and purpose in life. Boot-strapped analyses tested mediation. Greater personal resilience resources predicted decreases in PTSD stress symptoms (b = -0.07, p = 0.005), mediated by reductions in depressive symptoms (b = -0.01, 95% CI: -0.027, -0.003) and in searching for a reason for one's illness (b = -0.01, 95% CI: -0.034, -0.0003). In addition, greater resilience resources predicted increases in purpose in life (b = 0.10, p < 0.001), mediated by reductions in depressive symptoms (b = 0.02, 95% CI: 0.003, 0.033). Having greater personal resilience resources may promote better psychological adjustment after a difficult cancer treatment, largely because of improvements in depressive symptoms, although decreased use of a potentially maladaptive form of meaning-making (searching for a reason for one's illness) was also important for reducing PTSD symptoms.

Attitudes to Stem Cell Therapy Among Ischemic Stroke Survivors in the Lund Stroke Recovery Study.

Preclinical studies suggest that stem cell therapy (SCT) may improve poststroke recovery, and clinical trials investigating safety are ongoing. However, knowledge about patients' attitudes to SCT in stroke is limited. We evaluated the knowledge and attitudes to this therapeutic approach as well as possible factors influencing this among stroke patients potentially suitable for SCT. Consecutive first-ever acute ischemic stroke patients aged 20-75 years with NIH stroke scale scores 1-18 were included. Exclusion criteria were severe comorbidities or infratentorial stroke. Clinical follow-up after 3-5 years assessed severity of residual stroke symptoms, cognitive function, functional status, patient-reported outcome, and comorbidity, and after receiving standardized information, the participants also completed an eight-item questionnaire on knowledge and attitudes about SCT. The relationships between clinical variables and positive attitude to SCT were assessed with logistic regression analyses. Of 108 patients included at baseline, 84 participated at follow-up and completed the questionnaire. In total, 12% had prior knowledge of SCT. When informed, 63% were positive toward it and 36% reported willingness to participate in SCT trials. Only 5%-8% expressed ethical considerations regarding different stem cell sources. Positive attitudes to SCT were associated with male gender (OR: 3.74; 95% CI: 1.45-9.61; P < 0.01) and better patient-reported outcome (OR: 1.02; 95% CI: 1.00-1.04; P < 0.05). In conclusion, stroke patients had limited prior knowledge of SCT, yet attitudes were positive among the majority after receiving standardized and neutral information. Gender and degree of stroke recovery may influence attitudes to SCT, indicating a need for targeted information to improve knowledge about SCT.

'Well, It's the Risk of the Unknown Right?': A Qualitative Study of Perceived Risks and Benefits of HIV Cure Research in the United States.

INTRODUCTION: Biomedical research towards an HIV cure is advancing in the United States and elsewhere, yet little is known about perceptions of risks and benefits among potential study participants and other stakeholders. We conducted a qualitative study to explore perceived risks and benefits of investigational HIV cure research among people living with HIV (PLWHIV), biomedical HIV cure researchers, policy-makers and bioethicists. METHODS: We conducted a qualitative research study using in-depth interviews with a purposive sample of PLWHIV, biomedical HIV cure researchers, policy-makers and bioethicists in 2015-2016. We analysed interview transcripts using thematic analysis anchored in grounded theory. RESULTS: We conducted and analyzed 36 key informant interviews. Qualitative analysis revealed four main findings. 1) Potential HIV cure study volunteers noted needing more information and education about the potential risks of HIV cure research. 2) Biomedical HIV cure researchers, policy-makers and bioethicists showed less awareness of social and financial risks of HIV cure research than PLWHIV. 3) Most respondents across the different categories of informants identified some risks that were too great to be acceptable in HIV cure research, although a subset of PLWHIV did not place an upper limit on acceptable risk. 4) PLWHIV showed a better awareness of potential psychological benefits of participating in HIV cure research than other groups of stakeholders. CONCLUSION: Our research suggests that PLWHIV have a variable understanding of the individual risks, sometimes substantial, associated with participating in biomedical HIV cure research studies. Community engagement and increased research literacy may help improve community understanding. Intensive informed consent procedures will be necessary for ethical study implementation. The current state of HIV cure research offers greater potential benefits to society than to participants. There is likely to be disagreement among regulators, researchers, clinicians, and potential participants about what constitutes acceptable risk for HIV cure studies.

Group-Based Trajectory Modeling of Distress and Well-Being Among Caregivers of Children Undergoing Hematopoetic Stem Cell Transplant.

Objective: To examine the trajectories of caregiver psychological responses in the year following their child's hematopoetic stem cell transplant (HSCT), and whether cognitive and social processing strategies differentiated between trajectories. Method: One hundred and eight caregivers randomized to the control condition of a cognitive-behavioral intervention study completed measures of distress, coping, and social support at baseline, 1 month, 6 months, and 1 year post HSCT of their child. Results: The majority reported moderate or low anxiety, depression, or distress that decreased over time, but a small group demonstrated high anxiety, depression, or distress that persisted or increased over time. Maladaptive coping was highest among caregivers in the high-persistent distress subgroup compared with the moderate-decreasing and low-stable groups. Adaptive coping was minimally associated with trajectory subgroups. Conclusions: Screening HSCT caregivers for distress and maladaptive coping may be useful in identifying caregivers likely to experience persistently high distress who may benefit from psychological intervention.

Factors Associated With Post-Traumatic Growth, Quality of Life, and Spiritual Well-Being in Outpatients Undergoing Bone Marrow Transplantation: A Pilot Study.

PURPOSE/OBJECTIVES: To examine the relationships between spiritual, religious, and sociodemographic factors and post-traumatic growth, quality of life, and spiritual well-being in outpatients undergoing bone marrow and/or stem cell transplantation (BMSCT).
. DESIGN: Cross-sectional, descriptive, exploratory.
. SETTING: Outpatient bone marrow transplantation clinic at the Tom Baker Cancer Centre in Calgary, Alberta, Canada.
. SAMPLE: 100 patients (21 pre-BMSCT and 79 post-BMSCT) accrued consecutively via non-probability sampling.
. METHODS: Study participants completed the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT), the Post-Traumatic Growth Inventory (PTGI), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), and a demographic questionnaire. Data analysis included descriptive statistics, t tests, and correlational analyses.
. MAIN RESEARCH VARIABLES: Demographic variables, FACT-BMT scores, PTGI scores, FACIT-Sp scores. 
. FINDINGS: The majority of participants identified themselves as being at least somewhat spiritual. Significant differences were noted between those who identified as being not religious at all versus having at least some religiosity in several subscales of the PTGI, as well as on the FACIT-Sp. Similarly, significant differences were observed between participants who identified as being not spiritual at all versus having at least some spirituality for several subscales on the PTGI. Most participants indicated they would be at least somewhat likely to recommend spiritual care to a new patient. 
. CONCLUSIONS: Most patients in this study within a publicly funded healthcare system self-identified with spirituality, used spiritual resources, and would recommend that other patients undergoing BMSCT seek the support of a spiritual care professional or chaplain. Spirituality, along with practical and relational factors, had a positive impact on certain aspects of post-traumatic growth, quality of life, and spiritual and physical well-being.
. IMPLICATIONS FOR NURSING: Oncology nurses are encouraged to routinely address spiritual issues. Findings from this study suggest that spirituality is not only important to patients undergoing BMSCT, but also may be an integral component of patients' post-traumatic growth, quality of life, and spiritual well-being.

A resilience intervention involving mindfulness training for transplant patients and their caregivers.

Solid organ and stem cell transplant patients and their caregivers report a substantial level of distress. Mindfulness-based stress reduction has been shown to alleviate distress associated with transplant, but there is limited experience in this population with other mindfulness-based interventions, or with combined transplant patient and caregiver interventions. We evaluated a novel, 6-week mindfulness-based resilience training (MBRT) class for transplant patients and their caregivers that incorporates mindfulness practice, yoga, and neuroscience of stress and resilience. Thirty-one heart, liver, kidney/pancreas, and stem cell transplant patients and 18 caregivers at Mayo Clinic in Arizona participated. Measures of stress, resilience, depression, anxiety, health-related quality of life, positive and negative affect, and sleep were completed at baseline, 6 weeks, and 3 months postintervention. At 6 weeks and 3 months, patients demonstrated significant (P<.005) improvements from baseline in measures of perceived stress, depression, anxiety, and negative affect. Quality-of-life mental component (P=.006) and positive affect (P=.02) also improved at follow-up. Most participants adhered to the program, were satisfied with class length and frequency, and reported improved well-being as a result of the class. MBRT holds promise as an intervention to enhance resilience and manage stress for transplant patients and their caregivers.

Medical performance and the 'inaccessible' experience of illness: an exploratory study.

We report a survey of audience members' responses (147 questionnaires collected at seven performances) and 10 in-depth interviews (five former patients and two family members, three medical practitioners) to bloodlines, a medical performance exploring the experience of haematopoietic stem-cell transplant as treatment for acute leukaemia. Performances took place in 2014 and 2015. The article argues that performances that are created through interdisciplinary collaboration can convey otherwise 'inaccessible' illness experiences in ways that audience members with personal experience recognise as familiar, and find emotionally affecting. In particular such performances are adept at interweaving 'objectivist' (objective, medical) and 'subjectivist' (subjective, emotional) perspectives of the illness experience, and indeed, at challenging such distinctions. We suggest that reflecting familiar yet hard-to-articulate experiences may be beneficial for the ongoing emotional recovery of people who have survived serious disease, particularly in relation to the isolation that they experience during and as a consequence of their treatment.

Exploring the Content of Post-Traumatic Stress Symptoms among Parents after Paediatric Stem Cell Transplant.

In the present study the aim was to explore the content in a trauma reported in a self-report questionnaire by parents of children with a life threatening illness. Semi-structured interviews were performed, with the aim to explore the specific cognitive and behavioral content of the trauma related symptoms reported by the individual informant. The transcripts of the interviews were analyzed with content analysis using a direct approach with a-priori categories according to the B and C categories of the DSM-IV diagnostic criteria for PTSD. The results give us the picture of a complex situation, where the self-report instrument PCL captured a spectrum of qualitatively different cognitions. The parents described traumatic thoughts and images relating not only to experiences in the past (i.e., truly post-traumatic), but also to current stressors and expected future events.

Posttraumatic stress symptoms predict impaired neutrophil recovery in stem cell transplant recipients.

OBJECTIVE: Despite the potentially life-saving effects of stem cell transplant (SCT), many transplant patients experience traumatic stress reactions due to mortality threat, interpersonal isolation, financial and occupational loss, and invasive medical procedures. Emerging evidence suggests that trauma-related stress symptoms (TSS) predict significant health complications following SCT. The aim of the current prospective study was to examine TSS in the acute aftermath of SCT as a predictor of neutrophil recovery following SCT, a crucial component of immune defense against infection. METHODS: Fifty-one autologous SCT recipients were assessed for TSS 7 days after SCT. Patients' absolute neutrophil counts were collected from medical charts for the first 30 days following SCT. Hierarchical linear growth modeling was used to test the hypothesis that TSS at day 7 would be associated with delayed recovery of neutrophil counts from days 9 to 30 post SCT, that is, when neutrophil counts began to recover. RESULTS: As hypothesized, TSS measured 7 days after SCT was significantly associated with slower neutrophil recovery even after pre-existing TSS, depression, distress related to physical symptoms, and potential medical confounds were statistically controlled. Exploratory analyses showed that of the TSS symptom clusters, re-experiencing symptoms and hyperarousal symptoms predicted neutrophil recovery, whereas avoidance symptoms did not. CONCLUSION: Though traumatic stress symptoms may be a normative response to SCT, our findings suggest that TSS following SCT may interfere with neutrophil recovery and overall health. These results provide further insight as to potential mechanisms by which traumatic stress translates to poor medical outcomes for SCT patients.

Exploring the Cancer Experiences of Young Adults in the Context of Stem Cell Transplantation.

BACKGROUND: Cancer is the leading cause of nonaccidental morbidity and mortality among young adults (YAs) in the United States. Stem cell transplantation (SCT), a treatment modality for a variety of YA malignancies, often requires prolonged hospitalization and immune-compromising treatment regimens. Stem cell transplantation may isolate YAs physically and emotionally, contributing to uncertainty about treatment processes, outcomes, and long-term sequelae. Studies in this population suggest that uncertainty can contribute to difficulty accomplishing basic developmental tasks. Few studies have examined the experiences of YAs in active cancer treatment, particularly those undergoing SCT. OBJECTIVES: This study explored the cancer experiences of YAs aged 18 to 25 years leading up to SCT and explored how YAs construct issues of uncertainty related to the transplantation experience. METHODS: Interviews with 14 YAs conducted within 24 hours of admission to undergo SCT were analyzed using thematic analysis from a medical ethnographic perspective. RESULTS: Themes emerged within 2 domains: relational and psychoemotional. The relational theme of "altered relationships" included the subthemes of "moving from" and "moving toward." The psychoemotional theme of the "power of perspective" included the subthemes of "optimism," "acknowledgment of death," "informational empowerment," and "developing a new outlook." CONCLUSIONS: Our findings offer new insights into the YA experience in the context of active cancer treatment, specifically how the cancer experience impacts relationships and how this experience is influenced by YAs' perspectives. IMPLICATIONS FOR PRACTICE: This study provides a foundation for addressing the psychosocial needs of YAs hospitalized for SCT, paying particular attention to the development of specific interventions.