Patient Interest in Exploring Nonsurgical Treatment Approaches for Early-Stage Breast Cancer: A Qualitative Study.

PURPOSE: Advances in radiation therapy have enabled the ability to deliver ablative treatments, but there has been limited application of these treatments to early-stage breast cancers with a goal of omitting surgery. The purpose of this study was to explore patient interest in pursuing nonsurgical treatment approaches for their early-stage breast cancer. METHODS AND MATERIALS: We conducted a qualitative study involving interviews with 21 patients with early-stage breast cancer who were eligible for participation in a phase 2 clinical trial offering omission of definitive surgery. Interviews were transcribed and an inductive, thematic analysis was performed by 3 independent reviewers to generate themes and subthemes. RESULTS: Data analysis revealed the following factors that affected patient willingness and desire to explore nonsurgical treatment options: (1) perceptions and feelings about their cancer; (2) current quality of life and the level of support available in their daily life; (3) external conversations focusing on family members' and friends' experiences with cancer and/or cancer treatments; (4) personal health care experiences, including their current breast cancer diagnosis; (5) perceptions and feelings about their physicians; (6) conversations with their physicians about their treatment options; and (7) self-identified desire to direct care decisions. Specifically, patients verbalized fearing surgery and surgical recovery; wanting to preserve their breast(s); the prior negative surgical experiences of friends, family, and themselves; a desire to receive treatment per the latest research; wanting to match the level of treatment with the severity of their cancer; and other comorbidities as reasons for wanting to explore omitting surgery. CONCLUSIONS: Our findings demonstrate an unmet need directed by patient interest to explore nonsurgical options for early-stage, biologically favorable breast cancer. These results may shape conversations around shared decision-making and clinical trial design, and result in more personalized treatment options for women with early-stage breast cancer.

Impact of Immune Checkpoint Inhibitor Therapy on Quality of Life in Patients With Advanced Melanoma: A Systematic Review.

BACKGROUND: Immune checkpoint inhibitors (ICIs) were approved to treat advanced melanoma (AM) because of meaningful clinical benefit. These early data reported that ICI therapy is generally well tolerated, and despite symptoms, patients reported a high global health-related quality of life (HRQOL). OBJECTIVE: Immune checkpoint inhibitors are widely used in the oncology community; the aim of this systematic review was to evaluate current data on ICI therapy and its impact on HRQOL of patients with AM. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed during this systematic review to identify and select studies from the PubMed, OVID, EMBASE, and Cochrane databases. Selected studies were downloaded into Covidence and analyzed for trends in how ICI therapy impacts HRQOL in patients with AM. Multiple tools were used to assess the quality of the studies. RESULTS: The 16 studies included 12 quantitative, 2 qualitative, and 2 mixed-methods studies. The quality of the studies was moderate (n = 7) or strong (n = 9). Symptoms that impacted HRQOL were fatigue, endocrine dysfunction, rash, diarrhea, cognitive impairment, emotional impact (anxiety and depression), and financial toxicity. Suicidal ideation and 1 attempt were reported in 2 studies, which had not been previously published. CONCLUSION: Patient-reported symptoms due to ICI negatively impacted HRQOL. Anxiety and depression are prevalent. Current QOL instruments do not capture the entire patient experience. IMPLICATIONS FOR PRACTICE: Patients need to be asked if their symptoms are impacting their HRQOL. Further prospective research is needed to develop or adjust current patient-reported outcome instruments to adequately capture the impact of ICIs on HRQOL.

A guide to using technological applications to facilitate systematic reviews.

BACKGROUND: A systematic review (SR) synthesizes evidence in a reproducible way and informs evidence-based decision-making. SRs are time-intensive, particularly with respect to staying organized, maintaining records, and managing different phases of the process. Although there are numerous methodological guides to lead researchers in the approach to SRs to minimize bias and enhance rigor, there is less focus on technological approaches that can make the SR process easier for researchers. AIM: To guide researchers through the currently available technological applications that can assist with the SR process and synthesis of scientific literature. METHODOLOGY: Key ways that technological applications can facilitate the SR process are examined. RESULTS: Specific applications are discussed and stratified by their support of one or multiple phases of the systematic review process. Key features, strengths, and limitations are provided for technological applications that support the SR process. LINKING EVIDENCE TO ACTION: This paper guides researchers in different ways technology can support SRs. Through use of these applications, the researcher can complete SRs in a timely manner and manage the process effectively.

The Bereavement Experience for Partners of Patients With Central Nervous System Tumors.

PURPOSE: To describe the experience of caregivers who have lost a partner to a central nervous system (CNS) tumor. PARTICIPANTS & SETTING: 8 bereaved partners of patients with CNS tumors enrolled in a dyadic, behavioral randomized controlled trial at a comprehensive cancer center in the southern United States. METHODOLOGIC APPROACH: Participants took part in a semistructured qualitative interview to describe the experience of their partner's death. Descriptive exploratory analysis was used to identify themes emerging from the interviews. FINDINGS: Themes identified from bereaved participants' experiences were related to caring for their partner, separating from their partner on patient death, and continuing without their partner following patient death. IMPLICATIONS FOR NURSING: Bereaved partners of patients with CNS tumors described how difficult it was to experience the patient's health decline and feeling unprepared for the patient's death, regardless of advance notice. Interventions targeting caregiver distress to improve their experience prior to and following the patient's death are needed.

Parents' Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation.

OBJECTIVES: Phase 1 clinical trials are essential in the development of novel therapies for childhood cancers. Children with cancer can participate in phase 1 clinical trials when no known curative therapy remains. Understanding the experiences of children and their families in these clinical trials can help ensure that participation supports the children's and parents' well-being. This article explores the specific aspects of pediatric oncology phase 1 trials that parents found particularly challenging. DATA SOURCES: This qualitative, empirical phenomenology study considered 11 parents' experiences during the time their child with cancer participated in a phase 1 clinical trial. The primary study results were previously reported. This article reports parents' insights into the processes and procedures that occurred as part of participation in a pediatric oncology phase 1 trial. CONCLUSION: Parents' experiences during the phase 1 clinical trials were primarily positive. However, data analysis revealed five aspects of these trials that were challenging for families: learning about clinical trials, being referred to another institution, research-only procedures, adhering to trial requirements, and oral medications. IMPLICATIONS FOR NURSING PRACTICE: Although experiences during phase 1 clinical trials were positive overall, opportunities to enhance children's and parents' experiences warrant attention. Enhancing the education provided to families during recruitment and minimizing the logistical burdens associated with trial requirements through care coordination may alleviate challenges experienced by children and parents.

Using REDCap to Facilitate Web-Based Therapeutic Intervention Research.

BACKGROUND: Limited guidelines to assist nurse researchers who use web-based interventions are available. Nurses must develop the supporting technology enabling participants to complete study activities and collected data while maintaining data security and participant confidentiality. OBJECTIVES: The aim of the study was to describe how the authors used advanced Research Electronic Data Capture (REDCap) functionality to support the data management infrastructure of an interactive, web-based therapeutic intervention. METHODS: The data management infrastructure for the WISER (Writing to Improve Self-in-Relationships) intervention pilot study consisted of two components: a website for presentation of the intervention and participant account management and a REDCap project for data capture and storage. The REDCap application programming interface connected these two components using HTML links and data exchanges. RESULTS: We completed an initial pilot study of WISER with 14 participants using the REDCap-based infrastructure. Minimal technical difficulties were encountered. DISCUSSION: REDCap is cost-effective, is readily available, and, through its advanced functionality, is able to facilitate confidential, secure interactions with participants, robust data management, and seamless participant progression in web-based intervention research.

Evaluation of the burdens and benefits of participation in research by parents of children with life-limiting illnesses.

BACKGROUND: Research is needed to improve care and diminish suffering for children with life-limiting illnesses and their parents. However, there are doubts about whether it is possible to conduct paediatric end of life research safely and ethically, as it may unduly burden or inadvertently harm participants. AIM: To compare and evaluate responses from participants to the assessments of burdens and benefits that were conducted at two timepoints during a phenomenological study that investigated parents' experiences of having a child with life-limiting cancer participate in a Phase I clinical trial. DISCUSSION: Parents reported that participating in the study was beneficial and resulted in minimal burden or distress. The assessment of benefits and burdens at the first timepoint appeared sufficient to understand participants' experiences. CONCLUSION: This study adds to the evidence that research may be safely and effectively conducted with parents of children who are deceased or have life-limiting illnesses. Further research is needed to evaluate the most effective timing of assessments of the burdens and benefits of their participation in research. IMPLICATIONS FOR PRACTICE: It is important when conducting research with people with life-limiting illnesses or their family members to assess the burdens and benefits of their participation, to understand their experiences and assist in its conduct.

Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials.

Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

Engaging Clinical Nurses in Research: Nurses' Experiences Delivering a Communication Intervention in a Behavioral Oncology Clinical Trial.

Despite the recognized need for clinical nurses to engage in the conduct of research, little is known about their research experiences. This article describes the experiences of nurses who delivered the communication intervention in a behavioral oncology clinical trial for parents of adolescents and young adults (AYAs) with cancer. A qualitative thematic analysis was conducted of nurse interveners' (NIs') reflections on their experiences delivering the communication intervention. Ten data-generating questions were developed to guide NIs' reflections. Twelve NIs responded via verbal discussions. Six of these also provided written responses. Overall, nurses' experiences as interveners were powerful and positive, and included time and space to be fully present with patients and families. Nurse interveners identified barriers to their involvement in research related to time constraints, administrative support, physical space to privately conduct the intervention, and difficulties maintaining expertise with the intervention. The importance of ongoing collaboration between nurses, unit staff, leaders, and study teams was corroborated. An unexpected finding was the importance of reflective clinical research.

A feasibility test of an online intervention to prevention dating violence in emerging adults.

Dating violence in emerging adults is a significant problem and few prevention programs based on the developmental needs of this age group have been developed. Our research team developed an online dating violence prevention program called WISER (Writing to Improve Self-in-Relationships) for emerging adults. The program is based on narrative therapy principles and uses structured writing techniques. A single group pre-post feasibility test of WISER was conducted with 14 college women. WISER was demonstrated to be feasible and acceptable and to show promise as an effective program to decrease dating violence in this population.

Parental Experiences of Child Participation in a Phase I Pediatric Oncology Clinical Trial: "We Don't Have Time to Waste".

Children with cancer are only eligible for phase I clinical trials (P1Ts) when no known curative therapy remains. However, the primary aims of P1Ts are not focused on directly benefiting participants. This raises ethical concerns that can be best evaluated by exploring the experiences of participants. An empirical phenomenology study, using an adapted Colaizzi method, was conducted of 11 parents' lived experiences of their child's participation in a pediatric oncology P1T. Study findings were that parents' experiences reflected what it meant to have a child fighting to survive high-risk cancer. Although elements specific to P1T participation were identified, more pervasive was parents' sense of running out of time to find an effective treatment and needing to use time they had with their child well. Even though some problems were identified, overall parents did not regret their child's P1T participation and would recommend P1Ts to other parents of children with cancer.

Well-Being of Child and Family Participants in Phase 1 Pediatric Oncology Clinical Trials.

PROBLEM IDENTIFICATION: Pediatric oncology phase 1 clinical trials (P1Ts) are essential to developing new anticancer therapies; however, they raise complex ethical concerns about balancing the need for this research with the well-being of participating children. The purpose of this integrative review was to synthesize and appraise the evidence of how P1T participation, which begins with consent and ends with the transition off the P1T, can affect the well-being (either positively or negatively) of children with cancer. The Resilience in Individuals and Families Affected by Cancer Framework, which has an outcome of well-being, was used to synthesize findings. LITERATURE SEARCH: Articles on the experiences of child (n = 21) and adult (n = 31) P1T participants were identified through systematic searches. DATA EVALUATION: Articles were evaluated on rigor and relevance to P1T participant experiences as high, medium, or low. SYNTHESIS: Minimal empirical evidence was found regarding the effect of P1T participation on the well-being of children with cancer. Adult P1T participant experiences provide insights that could also be important to children's P1T experiences. IMPLICATIONS FOR PRACTICE: To achieve a balanced approach in P1T consent discussions, nurses and healthcare providers who work with children considering participation in a P1T should share the potential effect of participation on participants' well-being.

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early-Phase Pediatric Oncology Clinical Trial: A Pilot Study.

PURPOSE: Early-phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. METHODS: In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention and completion of measures. Measures completed included the following: demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. RESULTS: Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. CONCLUSIONS: While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition.

Designing an Internet Intervention for Emerging Adults Who Experience Troubled Relationships.

This article describes how the Internet Intervention Model (IIM) was used as an organizing framework to design a theoretically based Internet intervention for emerging adults who experience troubled intimate partner relationships. In the design process, the team addressed six fundamental questions related to the several components of the IIM. Decisions made regarding the design of the intervention based on the six questions are described. We focus in particular on how the intervention is based on the Theory of Emerging Adulthood and the Theory of Narrative Identity.

Understanding Ethical Issues of Research Participation From the Perspective of Participating Children and Adolescents: A Systematic Review.

BACKGROUND: The past 20 years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children's and adolescents' experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population. AIMS: The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives. METHODS: This systematic review was conducted per the Long, Godfrey, Randall, Brettle, and Grant framework by means of an iterative searching process. Using the key words "research ethics" and "child or pediatric or adolescent," PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the searches were: English language, year of publication between 2003 and 2014, humans, abstract available, and age birth-18 years. FINDINGS: Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals. LINKING EVIDENCE TO ACTION: Even young children demonstrated the ability to understand essential elements of research, although there is variability in children's level of understanding. Trust was a significant contributing factor to children's and adolescents' participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed.

Frontolimbic activity and cognitive bias in major depression.

In order to explore neural activity that accompanies cognitive bias in mood disorders, the authors had clinically depressed and nondepressed controls complete a self-evaluation procedure in which they indicated whether trait words were self-descriptive. Dense-array (256-channel) electroencephalography was recorded. Greater depression and low Positive Affect were associated with decreased endorsement of favorable (Good) traits, and greater anxiety and high Negative Affect were associated with increased endorsement of unfavorable (Bad) traits. For controls, the event-related potential (ERP) showed an enhanced visual N1 for trials in which Bad traits were endorsed. For depressed participants, this N1 was attenuated, specifically for these endorsed Bad trials. A similar pattern was observed in the P2-medial frontal negativity (P2-MFN) complex, with controls showing an enhanced MFN to the endorsed Bad words, while depressed participants showed an attenuated or absent medial frontal response on these items specifically. Distributed linear-inverse source analysis of the ERP localized the N1 effect to the inferotemporal-occipital cortex and the medial frontal effect to the dorsal anterior cingulate cortex. The altered ERP responses in depressed participants may provide clues to the neurophysiological processes associated with negatively biased cognition and self-evaluation in clinical depression.