A self-management plus mind body intervention for adolescents and young adults with type 2 diabetes: Trial design and methodological report.

BACKGROUND: The onset of type 2 diabetes (T2D) is increasingly common in adolescents and young adults (AYAs). Improving self-management skills and the mental health of this population is important, but understudied. METHODS: The goal of this research was to develop a mind-body intervention which could serve as an adjunctive therapy to support AYAs with T2D (INTEND intervention). Toward that end, we used an iterative process, including use of focus groups, advisory board, and cognitive semi-structured interviews with patients, parents of patient and clinical providers, to understand the gaps in the current information provided to AYAs with T2D. Based on the data gathered from the focus groups and interviews, we enhanced an existing self-management intervention for adults with T2D to include an additional mind body intervention for AYAs with T2D. The INTEND intervention will be piloted in a group of AYAs with T2D. RESULTS: This report describes the methodology and design of the InterveNTion for Early oNset type 2 Diabetes (INTEND) study. The details of this single arm pre-post pilot feasibility trial are described. DISCUSSION: If successful, the INTEND approach has the potential to advance care for vulnerable youth with T2D.

The Impact of Individualized Complementary and Integrative Health Interventions Provided in Clinical Settings on Quality of Life: A Systematic Review of Practice-Based Research.

Background: The goal of this systematic review was to evaluate the impact of individualized complementary and integrative health (CIH) interventions on quality-of-life outcomes as collected in CIH outpatient clinics. Methods: A systematic review was conducted using PubMed, OVID, Cochrane, Web of Science, Scopus, and Embase through December 2020. Inclusion criteria were as follows: individualized CIH treatment, longitudinal effectiveness design, patient-reported outcomes, outpatient CIH clinic setting, participants aged ≥18 years, sample size of ≥25, and English full text. The study was listed in the PROSPERO database (CRD42020159193), and PRISMA guidelines were used. The variables extracted from articles focused on study details/demographics, CIH intervention characteristics, and outcome characteristics. Results: The literature search yielded 3316 records with 264 assessed for full-text review. Of these, 19 studies (including ∼14,002 patients) were specific to quality of life (or well-being) as a main outcome. Most studies included were multidisciplinary studies (n = 12), followed by acupuncture (n = 4), chiropractic (n = 3), and massage or reflexology (n = 1). The short-form group of questionnaires (SF-12, SF-36, SF-8) were the most used quality-of-life/well-being questionnaire, comprising 37% of studies (n = 7), and the Patient Reported Outcomes Measurement Information System (PROMIS) measures comprised 21% (n = 4). Both questionnaires are normed to U.S. population, allowing for comparison. The average improvement across the comparable SF and PROMIS measures for Physical Health was 6% (range 2%-20%) and for Mental Health was 5% (range 1%-11%), demonstrating clinical significance. Improvements in the observational studies are comparable to improvements reported from randomized controlled trials. Conclusions: Results from this systematic review indicate that CIH therapies largely have positive effects on health-related quality of life and well-being for various patient populations seen in CIH clinical settings. Direct comparisons across studies were limited due to the variability in study design and incomplete reporting in some of the publications. Suggestions for improving the design and reporting for future practice-based research are provided.

Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.

PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action.

OBJECTIVE: The goal of this systematic review was to evaluate practice-based, real-world research of individualized complementary and integrative health (CIH) therapies for pain as provided in CIH outpatient clinics. METHODS: A systematic review was conducted on articles in PubMed, Ovid, Cochrane, Web of Science, Scopus, and Embase published through December 2020. The study was listed in the PROSPERO database (CRD42020159193). Major categories of variables extracted included study details and demographics, interventions, and outcomes. RESULTS: The literature search yielded 3,316 records, with 264 assessed for full-text review. Of those, 23 studies (including ∼8,464 patients) were specific to pain conditions as a main outcome. Studies included chiropractic, acupuncture, multimodal individualized intervention/programs, physiotherapy, and anthroposophic medicine therapy. Retention rates ranged from 53% to 91%, with studies offering monetary incentives showing the highest retention. The 0-10 numerical rating scale was the most common pain questionnaire (n = 10; 43% of studies), with an average percent improvement across all studies and time points of 32% (range: 18-60%). CONCLUSIONS: Findings from this systematic review of practice-based, real-word research indicate that CIH therapies exert positive effects on various pain outcomes. Although all studies reported beneficial impacts on one or more pain outcomes, the heterogeneous nature of the studies limits our overall understanding of CIH as provided in clinical settings. Accordingly, we present numerous recommendations to improve publication reporting and guide future research. Our call to action is that future practice-based CIH research is needed, but it should be more expansive and conducted in association with a CIH scientific society with academic and health care members.

Randomized trial of a web-based nurse education intervention to increase discussion of clinical trials.

BACKGROUND: Clinical trials are a critical source of evidence for oncology care, yet very few patients participate. Among healthcare providers, nurses spend the most time with cancer patients and are the most highly trusted professionals. We developed and evaluated an educational program for oncology nurses targeting knowledge, attitudes, self-efficacy and perceived norms to facilitate discussion about clinical trials and support patient decision making. METHODS: A nationwide sample of oncology nurses were randomly assigned to receive general clinical trials education delivered as text (attention control) vs. tailored video vignettes (intervention) in a web-based continuing education program. Participants completed a baseline assessment and follow up assessments immediately after the educational program and three months later. The primary outcome was intention to discuss clinical trials with patients. Secondary outcomes were knowledge and attitudes about clinical trials, self-efficacy, and perceived norms. RESULTS: 1393 nurses enrolled and completed the educational program and post-intervention assessment (720 control, 673 video). Both text education and tailored video education increased intention to discuss clinical trials with patients, with a greater effect in the video group (p < .0001). Likewise, knowledge, attitudes, perceived behavioral control, and perceived norms were all improved with education in both groups, and the magnitude of benefit was greater (p < .001) for the video group in all outcomes except knowledge. CONCLUSION: A one-time online educational program for oncology nurses improves knowledge, attitudes, self-efficacy and intention to engage patients in discussions about clinical trials. A tailored video format was associated with a greater effect than standard text only material.

A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials.

PURPOSE: Patients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine differences in study duration, symptom burden, adverse events (AE), and quality of life (QOL) between those receiving structured palliative care versus usual supportive care. PATIENTS AND METHODS: Sixty-eight patients enrolled in phase 1 clinical trials and 39 of their CGs were randomly assigned to receive structured palliative care or usual supportive care. Patient QOL was measured monthly using the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale. The Quality of Life in Life-Threatening Illness-Family Care Version and Caregiver Reaction Assessment were used for CGs. AEs and use of palliative care resources were compared between arms. RESULTS: Mean duration of the phase 1 study was 142 days in the palliative care arm versus 116 days in the usual care arm (p = 0.55). Although not statistically significant, patients in the palliative care arm experienced fewer AEs and better QOL, as did their CGs, compared to those receiving usual care. CONCLUSIONS: Phase 1 patients and their CGs have physical and psychosocial needs warranting palliative care services. Results suggest that structured palliative care is associated with the increased duration of the study and improved patient and CG QOL.

Recruitment Strategies for Nurse Enrollment in an Online Study.

BACKGROUND: Although there is a great deal of literature regarding effective recruitment and challenges of recruiting specific patient populations, there is less known about best practices for recruitment of nurses as study subjects. OBJECTIVES: The purpose of this article is to report our experience with recruitment and retention for a randomized trial of an online educational program to prepare oncology nurses to discuss oncology clinical trials with patients. METHODS: The study population included currently employed oncology nurses with direct patient interaction. There were three phases of this study: (1) qualitative interviews, (2) a pilot test, and (3) the randomized trial. Phase 3 was rolled out in five waves of recruitment. The distinct phases of the study-and the gradual roll out of recruitment during Phase 3-allowed us to test and refine our recruitment and retention methods for the randomized trial. Upon analysis of our response rate and attrition after the first wave of recruitment in Phase 3, we made several changes to improve recruitment and retention, including adding incentives, shortening the survey, and increasing the number of reminders to complete the program. RESULTS: The response rate was higher when we used both e-mail and U.S. postal mail solicitations. After the first wave of recruitment in the final phase, changes in our strategies did not increase our overall response rate significantly; however, the rate of attrition following baseline declined. DISCUSSION: Recruitment planning is an important component of successful clinical research. The use of the Internet for both recruitment of subjects and testing of interventions remains a cost-effective and potentially high yield methodology. Our research demonstrated several successful approaches to yield increased participation and retention of subjects, including seeking formal relationships with professional organizations as sponsors or supporters, providing meaningful incentives to participants, keeping surveys or questionnaires as short as possible, and planning multiple follow-up contacts from the outset.

The Role of Oncology Nurses in Discussing Clinical Trials.

PURPOSE/OBJECTIVES: To describe oncology nurses' experiences discussing clinical trials with their patients, and to assess barriers to these discussions.
. RESEARCH APPROACH: A qualitative study designed to elicit narratives from oncology nurses. 
. SETTING: Community- and academic-based oncology clinics throughout the United States.
. PARTICIPANTS: 33 oncology nurses involved in direct patient care in community-based and large hospital-based settings. The sample was drawn from members of the Oncology Nursing Society. 
. METHODOLOGIC APPROACH: In-depth interviews were conducted and analyzed using a immersion/crystallization approach to identify themes and patterns. The analyses highlight specific issues, examples, and contexts that present challenges to clinical trial discussions with patients.
. FINDINGS: Oncology nurses view their roles as patient educators and advocates to be inclusive of discussion of clinical trials. Barriers to such discussions include lack of knowledge and strategies for addressing patients' common misconceptions and uncertainty about the timing of discussions.
. INTERPRETATION: These data indicate that enabling nurses to actively engage patients in discussions of clinical trials requires educational interventions to build self-efficacy and close knowledge gaps. 
. IMPLICATIONS FOR NURSING: Oncology nurses can play a critical role in advancing cancer care by supporting patients in decision making about clinical trial participation. This will require training and education to build their knowledge, reduce barriers, and increase their self-efficacy to fulfill this responsibility in various clinical settings.