Browsing by Author "Moody, Karen M."

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    COMPLETE (Communication Plan Early Through End of Life): Development of a Research Program to Diminish Suffering for Children at End of Life
    (Elsevier, 2021) Hendricks-Ferguson, Verna; Newman, Amy R.; Brock, Katharine E.; Haase, Joan E.; Raybin, Jennifer L.; Saini, Shermini; Moody, Karen M.; School of Nursing
    While overall survival has improved significantly for children with cancer over the past 75 years, cancer remains the leading cause of death from disease among children and adolescents. Further, despite the many advances in medical and nursing care, children with cancer still experience significant physical and emotional suffering over the course of their illness, especially at the end of life (EOL). Children endure significant rates of high-intensity medical interventions (e.g., intubation, intensive care unit admission) at the EOL despite many parents, adolescents, and young adult patients identifying home as their preferred location of death. Hospice care has the potential to ease suffering at the EOL and facilitate home deaths, and yet, most children still die in acute care settings without hospice care. Numerous barriers prevent timely enrollment in hospice among children with cancer who are in the EOL period. This report describes the development and testing of a palliative care/EOL communication intervention designed to overcome some of these barriers and subsequently improve EOL outcomes (i.e., earlier hospice enrollment, less use of high-intensity medical interventions, reduced pain and suffering) among children with cancer and their parents (i.e., less emotional distress and uncertainty, improved hope and healthcare satisfaction).
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    Ensuring Intervention Fidelity of an Attention Control Arm in a Multi-Site Randomized Controlled Trial
    (Wolters Kluwer, 2024) Newman, Amy R.; Moody, Karen M.; Becktell, Kerri; Connelly, Erin; Holladay, Cynthia; Parisio, Katie; Powell, Jonathan L.; Steineck, Angela; Hendricks-Ferguson, Verna L.; Pediatrics, School of Medicine
    Background: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. Objectives: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. Methods: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Results: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Discussion: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.
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    Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer
    (Sage, 2023-12-25) Robb, Sheri L.; Stegenga, Kristin; Perkins, Susan M.; Stump, Timothy E.; Moody, Karen M.; Henley, Amanda K.; MacLean, Jessica; Jacob, Seethal A.; Delgado, David; Haut, Paul R.; School of Nursing
    Objective: This trial examined the effects of proximal/distal mediators and moderators of an Active Music Engagement (AME) intervention on young child/parent distress, quality of life, and family function outcomes. Methods: Child/parent dyads (n = 125) were randomized to AME or Audio-storybooks attention control condition. Each group received 3 sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention (T2), and 30-days later (T3). Potential proximal mediators included within session child and parent engagement. Potential distal mediators included changes in perceived family normalcy, parent self-efficacy, and independent use of play materials. Potential moderators included parent/child distress with prior hospitalizations, parent traumatic stress screener (PCL-6), and child age. Outcomes included child emotional distress and quality of life; parent emotion, traumatic stress symptoms (IES-R), well-being; and family function. Mediation effects were estimated using ANCOVA, with indirect effects estimated using the percentile bootstrap approach. Moderation effects were tested by including appropriate interaction terms in models. Results: No significant mediation effects were observed. Child distress with prior hospitalizations moderated AME effects for IES-R intrusion subscale scores at T2 (P = .01) and avoidance subscale scores at T3 (P = .007). Traumatic stress screener scores (PCL-6) moderated intervention effects for IES-R hyperarousal subscale scores at T2 (P = .01). There were no moderation effects for child age. Conclusions: AME is a promising intervention for mitigating traumatic stress symptoms and supporting well-being in parents of children with cancer, particularly for parents who screen high for traumatic stress and whose children are more highly distressed with hospitalization.