Ensuring Treatment Fidelity in a Multi-site Behavioral Intervention Study: Implementing NIH Behavior Change Consortium Recommendations in the SMART Trial

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children’s Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11–24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the NIH Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in 5 specific areas: 1) study design, 2) training providers, 3) delivery of treatment, 4) receipt of treatment, and 5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature illustrating the application of BCC recommendations in behavioral intervention studies

Birthing and Parenting a Premature Infant in a Cultural Context

The purpose of this longitudinal qualitative descriptive study was to explore American Indian (AI) mothers’ perceptions of parenting their premature infants over their first year of life in the context of their culture, including the birth and hospitalization experience. A convenience sample of 17 AI mothers and their premature infants were recruited from either a neonatal intensive care unit (NICU) or pediatric clinic in the southeast. Semistructured interviews were conducted at two time points. Through content analytic methods, three broad categories were revealed: descriptions of having a premature infant in the NICU, descriptions of parenting a premature infant, and the influence of Lumbee culture on parenting a premature infant. Certain aspects of AI culture appear to be important in having a premature infant in the NICU and in parenting a premature infant. We recommend that healthcare providers deliver culturally appropriate care that fully supports AI mothers and their premature infants

Nursing Roles and Strategies in End-of-Life Decision Making in Acute Care: A Systematic Review of the Literature

The objective of this paper is to analyze the literature concerning nurses' roles and strategies in EOL decision making in acute care environments, synthesize the findings, and identify implications for future research. We conducted searches in CINAHL and PubMed, using a broad range of terms. The 44 articles retained for review had quantitative and qualitative designs and represented ten countries. These articles were entered into a matrix to facilitate examining patterns, themes, and relationships across studies. Three nursing roles emerged from the synthesis of the literature: information broker, supporter, and advocate, each with a set of strategies nurses use to enact the roles. Empirical evidence linking these nursing roles and strategies to patients and family members outcomes is lacking. Understanding how these strategies and activities are effective in helping patients and families make EOL decisions is an area for future research

Relationship of Maternal Psychological Distress Classes to Later Mother-Infant Interaction, Home Environment, and Infant Development in Preterm Infants: MATERNAL PSYCHOLOGICAL DISTRESS

Latent class analyses can be used early in the postpartum period to identify mothers of preterm infants experiencing similar patterns of psychological distress symptoms, but whether these classes of mothers also differ in parental responses to their infants or in their infants’ development is largely unknown. In this longitudinal multisite repeated measures study, we evaluated the usefulness of three psychological distress classes (low distress, high depressive and anxiety symptoms, and extreme distress) in predicting mother-infant interactions, quality of home environment, and infant development in 229 mother-preterm infant pairs. Mothers completed psychological distress questionnaires at study entry; parent-infant interaction was recorded at two and six months of age corrected for prematurity; and infant developmental data were collected 12 months corrected age. Mothers in the extreme distress class engaged in more developmental stimulation at two months (β = 0.99, p < 0.01) and at six months (β = 1.38, p < 0.01) than mothers in the other classes and had better quality of home environment at two months (β = 2.52, p = 0.03). When not controlling for neurological insult, infants of mothers in the extreme distress class had poorer cognitive (β = −10.28, p = 0.01) and motor (β = −15.12, p < 0.01) development scores at 12 months corrected age than infants of mothers in the other distress classes, but after controlling for infant neurological insult, there were no differences in cognitive, motor and language development based on maternal psychological distress class

Recruitment strategies and rates of a multi-site behavioral intervention for adolescents and young adults with cancer

INTRODUCTION: To provide an overview of factors related to recruitment of adolescents and young adults (AYA) into research and recruitment rates and reasons for refusal from a multicenter study entitled "Stories and Music for Adolescent/Young Adult Resilience during Transplant" (SMART). METHODS: A randomized clinical trial study design was used. The settings included 9 hospitals. The sample included AYAs (aged 11-24 years) who were undergoing a stem cell transplant. Several instruments were used to measure symptom distress, coping, resilience, and quality of life in AYA with cancer. RESULTS: A total of 113 AYA were recruited (50%) for this study. Strategies were refined as the study continued to address challenges related to recruitment. We provide a description of recruitment strategies and an evaluation of our planning, implementing, and monitoring of recruitment rates for the SMART study. DISCUSSION: When designing a study, careful consideration must be given to factors influencing recruitment as well as special considerations for unique populations. Dissemination of strategies specific to unique populations will be helpful to the design of future research studies

Adolescent/Young Adult Perspectives of a Therapeutic Music Video Intervention to Improve Resilience During Hematopoietic Stem Cell Transplant for Cancer

This empirical phenomenology study reports adolescents/young adults (AYA) experiences of the therapeutic music video (TMV) intervention arm of a randomized controlled clinical trial (Children's Oncology Group; COG-ANUR0631; R01 NR008583) during hospitalization for a hematopoietic stem cell transplant. A purposive subsample of 14 AYA were interviewed using a broad open-ended data-generating question about their TMV intervention experiences. At the end of each interview, we also asked AYA for suggestions on how to improve the TMV. Analysis of the narrative data resulted in four theme categories: (a) An Interwoven Experience of the Transplant and TMV Intervention; (b) TMV as a Guided Opportunity for Reflection, Self-Expression, and Meaning-Making; (c) Telling My Story: The Work of Deriving Meaning; and (d) A Way to Overcome the Bad Side of Cancer. AYA suggestions for improving the TMV are also summarized. Findings provide insight into ways the TMV supports AYA efforts to overcome distress and challenges by providing opportunities to reflect on what is meaningful, connect with others, and explore/identify personal strengths. Findings also inform our understanding about how the TMV may have functioned (i.e., mechanisms of action) to bring about significant change in AYA self-reported outcomes (i.e., positive coping, social support, and family function) for this trial

Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group

BACKGROUND: To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. METHODS: This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). RESULTS: At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). CONCLUSIONS: The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers

Recommendations of Common Data Elements to Advance the Science of Selfâ Management of Chronic Conditions

PurposeCommon data elements (CDEs) are increasingly being used by researchers to promote data sharing across studies. The purposes of this article are to (a) describe the theoretical, conceptual, and definition issues in the development of a set of CDEs for research addressing selfâ management of chronic conditions; (b) propose an initial set of CDEs and their measures to advance the science of selfâ management; and (c) recommend implications for future research and dissemination.Design and MethodsBetween July 2014 and December 2015 the directors of the National Institute of Nursing Research (NINR)â funded P20 and P30 centers of excellence and NINR staff met in a series of telephone calls and a faceâ toâ face NINRâ sponsored meeting to select a set of recommended CDEs to be used in selfâ management research. A list of potential CDEs was developed from examination of common constructs in current selfâ management frameworks, as well as identification of variables frequently used in studies conducted in the centers of excellence.FindingsThe recommended CDEs include measures of three selfâ management processes: activation, selfâ regulation, and selfâ efficacy for managing chronic conditions, and one measure of a selfâ management outcome, global health.ConclusionsThe selfâ management of chronic conditions, which encompasses a considerable number of processes, behaviors, and outcomes across a broad range of chronic conditions, presents several challenges in the identification of a parsimonious set of CDEs. This initial list of recommended CDEs for use in selfâ management research is provisional in that it is expected that over time it will be refined. Comment and recommended revisions are sought from the research and practice communities.Clinical RelevanceThe use of CDEs can facilitate generalizability of research findings across diverse population and interventions.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/134268/1/jnu12233_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/134268/2/jnu12233.pd

Biomarkers as Common Data Elements for Symptom and Selfâ Management Science

PurposeBiomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a â minimum setâ of biomarkers for consideration as CDEs in symptom and selfâ management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance.Design and MethodsFrom May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and selfâ management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and selfâ management science are proposed along with implications for future research and use of CDEs in these areas.FindingsThe recommended minimum set of biomarker CDEs include proâ and antiâ inflammatory cytokines, a hypothalamicâ pituitaryâ adrenal axis marker, cortisol, the neuropeptide brainâ derived neurotrophic factor, and DNA polymorphisms.ConclusionsIt is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and selfâ management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and selfâ management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and selfâ management science.Clinical RelevanceThe use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and selfâ management science.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/143764/1/jnu12378.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/143764/2/jnu12378_am.pd

Exploring the vagueness of Religion & Spirituality in complex pediatric decision-making: a qualitative study

Abstract Background Medical advances have led to new challenges in decision-making for parents of seriously ill children. Many parents say religion and spirituality (R&S) influence their decisions, but the mechanism and outcomes of this influence are unknown. Health care providers (HCPs) often feel unprepared to discuss R&S with parents or address conflicts between R&S beliefs and clinical recommendations. Our study sought to illuminate the influence of R&S on parental decision-making and explore how HCPs interact with parents for whom R&S are important. Methods A longitudinal, qualitative, descriptive design was used to (1) identify R&S factors affecting parental decision-making, (2) observe changes in R&S themes over time, and (3) learn about HCP perspectives on parental R&S. The study sample included 16 cases featuring children with complex life-threatening conditions. The length of study for each case varied, ranging in duration from 8 to 531 days (median = 380, mean = 324, SD = 174). Data from each case included medical records and sets of interviews conducted at least monthly with mothers (n = 16), fathers (n = 12), and HCPs (n = 108). Thematic analysis was performed on 363 narrative interviews to identify R&S themes and content related to decision-making. Results Parents from 13 cases reported R&S directly influenced decision-making. Most HCPs were unaware of this influence. Fifteen R&S themes appeared in parent and HCP transcripts. Themes most often associated with decision-making were Hope & Faith, God is in Control, Miracles, and Prayer. Despite instability in the child’s condition, these themes remained consistently relevant across the trajectory of illness. R&S influenced decisions about treatment initiation, procedures, and life-sustaining therapy, but the variance in effect of R&S on parents’ choices ultimately depended upon other medical & non-medical factors. Conclusions Parents consider R&S fundamental to decision-making, but apply R&S concepts in vague ways, suggesting R&S impact how decisions are made more than what decisions are made. Lack of clarity in parental expressions of R&S does not necessarily indicate insincerity or underestimation of the seriousness of the child’s prognosis; R&S can be applied to decision-making in both functional and dysfunctional ways. We present three models of how religious and spiritual vagueness functions in parental decision-making and suggest clinical applications