Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial.

BACKGROUND: Cancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physical, social, and spiritual well-being both during and after primary cancer treatment. The purpose of this in-progress pilot trial is to determine acceptability and preliminary efficacy (as reflected by effect sizes) of CBCT® (Cognitively-Based Compassion Training) compared with a cancer health education (CHE) attention control to improve the primary outcome of depressive symptoms and secondary outcomes of other HRQOL domains (e.g., anxiety, fatigue), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related outcomes in both cancer survivors and informal caregivers. METHODS: Forty dyads consisting of solid tumor survivors who have completed primary treatments (chemotherapy, radiation, surgery) and their informal caregivers, with at least one dyad member with ≥ mild depressive symptoms or anxiety, will be recruited from Tucson, Arizona, USA. Survivor-caregiver dyads will be randomized together to complete either CBCT or CHE. CBCT is a manualized, 8-week, group meditation-based intervention that starts with attention and mindfulness and builds to contemplative practices aimed at cultivating compassion to the self and others. The goal of CBCT is to challenge unexamined assumptions about feelings and behaviors, with a focus on generating spontaneous self-compassion and increased empathic responsiveness and compassion for others. CHE is an 8-week, manualized group intervention that provides cancer-specific education on various topics (e.g., cancer advocacy, survivorship wellness). Patient-reported HRQOL outcomes will be assessed before, immediately after (week 9), and 1 month after CBCT or CHE (week 13). At the same time points, stress-related biomarkers of inflammation (e.g., plasma interleukin-6) and saliva cortisol relevant for survivor and informal caregiver wellness and healthcare utilization will be measured. DISCUSSION: If CBCT shows acceptability, a larger trial will be warranted and appropriately powered to formally test the efficacy of this dyadic intervention. Interventions such as CBCT directed toward both survivors and caregivers may eventually fill a gap in supportive oncology care programs to improve HRQOL and healthcare utilization in both dyad members. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03459781 . Prospectively registered on 9 March 2018.

Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study.

PURPOSE: This study assessed the feasibility of a meditation-based program called Cognitively-Based Compassion Training (CBCT) with breast cancer survivors. Enrollment and participant satisfaction with a novel intervention, adherence to program requirements, and differences between the intervention group and wait list controls on self-report measures were also assessed. Additionally, cortisol, a stress-related endocrine biomarker, was assessed. METHODS: Participants (n = 33) were randomly assigned to CBCT or the wait list. CBCT provided eight weekly, 2-h classes and a "booster" CBCT session 4 weeks later. CBCT participants were expected to attend classes and meditate between classes at least three times per week. Pre-/post-intervention and follow-up questionnaires measured symptom change (depression, intrusive thoughts, perceived stress, fear of cancer recurrence, fatigue/vitality, loneliness, and quality of life). Saliva samples were collected at the same periods to assess the slope of diurnal cortisol activity. RESULTS: Enrollment, class attendance, home practice time, and patient satisfaction exceeded expectations. Compared to controls, post-intervention, the CBCT group showed suggestions of significant improvements in depression, avoidance of intrusive thoughts, functional impairment associated with fear of recurrence, mindfulness, and vitality/fatigue. At follow-up, less perceived stress and higher mindfulness were also significant in the CBCT group. No significant changes were observed on any other measure including diurnal cortisol activity. CONCLUSIONS: Within the limits of a pilot feasibility study, results suggest that CBCT is a feasible and highly satisfactory intervention potentially beneficial for the psychological well-being of breast cancer survivors. However, more comprehensive trials are needed to provide systematic evidence. RELEVANCE: CBCT may be very beneficial for improving depression and enhancing well-being during breast cancer survivorship.

Pediatric Integrative Medicine in Residency (PIMR): Description of a New Online Educational Curriculum.

Use of integrative medicine (IM) is prevalent in children, yet availability of training opportunities is limited. The Pediatric Integrative Medicine in Residency (PIMR) program was designed to address this training gap. The PIMR program is a 100-hour online educational curriculum, modeled on the successful Integrative Medicine in Residency program in family medicine. Preliminary data on site characteristics, resident experience with and interest in IM, and residents' self-assessments of perceived knowledge and skills in IM are presented. The embedded multimodal evaluation is described. Less than one-third of residents had IM coursework in medical school or personal experience with IM. Yet most (66%) were interested in learning IM, and 71% were interested in applying IM after graduation. Less than half of the residents endorsed pre-existing IM knowledge/skills. Average score on IM medical knowledge exam was 51%. Sites endorsed 1-8 of 11 site characteristics, with most (80%) indicating they had an IM practitioner onsite and IM trained faculty. Preliminary results indicate that the PIMR online curriculum targets identified knowledge gaps. Residents had minimal prior IM exposure, yet expressed strong interest in IM education. PIMR training site surveys identified both strengths and areas needing further development to support successful PIMR program implementation.

Increasing resident recruitment into family medicine: effect of a unique curriculum in integrative medicine.

INTRODUCTION: Healthcare reform is highlighting the need for more family practice and other primary care physicians. The Integrative Medicine in Residency (IMR) curriculum project helped family medicine residencies pilot a new, online curriculum promoting prevention, patient-centered care competencies, use of complementary and alternative medicine along with conventional medicine for management of chronic illness. A major potential benefit of the IMR program is enhanced recruitment into participating residencies, which is reported here. METHODS: Using an online questionnaire, accepted applicants to the eight IMR pilot programs (n = 152) and four control programs (n = 50) were asked about their interests in learning integrative medicine (IM) and in the pilot sites how the presence of the IMR curriculum affected their ranking decisions. RESULTS: Of residents at the IMR sites, 46.7% reported that the presence of the IMR was very important or important in their ranking decision. The IMR also ranked fourth overall in importance of ranking after geography, quality of faculty, and academic reputation of the residency. The majority of IMR residents (87.5%) had high to moderate interest in learning IM during their residency; control residents also had a high interest in learning IM (61.2%). CONCLUSIONS: The presence of the IMR curriculum was seen as a strong positive by applicants in ranking residencies. Increasing the adoption of innovative IM curricula, such as the IMR, by residency programs may be helpful in increasing applications of competitive medical students into primary care residencies as well as in responding to the expressed interest in learning the IM approach to patient care.

IMPACT--Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model.

BACKGROUND: Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. METHODS/DESIGN: This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. DISCUSSION: The US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential. TRIAL REGISTRATION: Clinical Trials.gov NCT01785485.

When a whole practice model is the intervention: developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic.

Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC.

Resident wellness behaviors: relationship to stress, depression, and burnout.

BACKGROUND AND OBJECTIVES: Stress in medical education has been well documented, often with the primary focus on negative factors such as depression and burnout. Few studies have attempted to assess well-being mediating behaviors. This study describes the relationship between wellness behaviors and measures of well-being at the start of family medicine residency. METHODS: Using an online questionnaire, first-year family medicine residents (n=168) completed standardized measures exploring perceived stress, depression, satisfaction with life, and burnout. A lifestyle wellness behavior measure was developed for the study. RESULTS: Average reported perceived stress levels were consistent with ranges found for medical students and residents. Twenty-three percent of residents scored in a range consistent with depression risk. In terms of burnout risk, 13.7% scored in the high emotional exhaustion range and 23.8% in the high depersonalization range. Two thirds reported high life satisfaction. Higher depersonalization and less time in nurturing relationships were associated with greater likelihood of medication use for sleep, mood, and anxiety in females. Higher alcohol use was associated with increased levels of perceived stress, burnout, and depression. The two wellness behaviors most associated with higher well-being were restful sleep and exercise. CONCLUSIONS: At the start of residency, well-being measures are consistent with findings in medical school. Restful sleep and exercise were associated with more positive well-being. Future longitudinal data analysis will help clarify the effect of residency training in well-being and lifestyle behaviors. Identification of protective factors and coping mechanisms could guide residencies in incorporating support services for residents.

Integrative medicine in residency education: developing competency through online curriculum training.

INTRODUCTION: The Integrative Medicine in Residency (IMR) program, a 200-hour Internet-based, collaborative educational initiative was implemented in 8 family medicine residency programs and has shown a potential to serve as a national model for incorporating training in integrative/complementary/alternative medicine in graduate medical education. INTERVENTION: The curriculum content was designed based on a needs assessment and a set of competencies for graduate medical education developed following the Accreditation Council for Graduate Medical Education outcome project guidelines. The content was delivered through distributed online learning and included onsite activities. A modular format allowed for a flexible implementation in different residency settings. EVALUATION: TO ASSESS THE FEASIBILITY OF IMPLEMENTING THE CURRICULUM, A MULTIMODAL EVALUATION WAS UTILIZED, INCLUDING: (1) residents' evaluation of the curriculum; (2) residents' competencies evaluation through medical knowledge testing, self-assessment, direct observations, and reflections; and (3) residents' wellness and well-being through behavioral assessments. RESULTS: The class of 2011 (n  =  61) had a high rate of curriculum completion in the first and second year (98.7% and 84.2%) and course evaluations on meeting objectives, clinical utility, and functioning of the technology were highly rated. There was a statistically significant improvement in medical knowledge test scores for questions aligned with content for both the PGY-1 and PGY-2 courses. CONCLUSIONS: The IMR program is an advance in the national effort to make training in integrative medicine available to physicians on a broad scale and is a success in terms of online education. Evaluation suggests that this program is feasible for implementation and acceptable to residents despite the many pressures of residency.

Integrating mental health services into primary HIV care for women: the Whole Life project.

The high rate of mental health problems in HIV-infected women jeopardizes the health of this vulnerable population, and constitutes a mandate for integrating mental health services into HIV primary care. The Whole Life project-a collaboration of the departments of Psychiatry and Obstetrics/Gynecology at the University of Miami School of Medicine-successfully integrated mental health services into primary HIV care for women. This article describes the conceptual framework of the integration, implementation strategies, effects of the service integration, and lessons learned. Funded by the Health Resources and Services Administration (HRSA) as a Special Program of National Significance (SPNS), Whole Life efforts have been sustained beyond the demonstration funding period as a result of the changes brought about in organizational structures, service delivery, and the providers' conceptualization of health for HIV-infected women.

Case finding for HIV-positive youth: a special type of hidden population.

PURPOSE: To describe the HIV case finding strategies used by the Special Projects of National Significance (SPNS), Adolescent HIV Outreach and Treatment programs, the populations of youth they were able to reach, and the populations of HIV-positive youth they were able to identify. METHODS: Program specifications from five programs located in four major metropolitan centers were contrasted. Four of the programs also provided outcome data for HIV counseling and testing outcome numbers, demographic and risk profile data for youth who underwent HIV testing, and mode of infection of HIV-positive youth. RESULTS: The program outcomes were discussed in terms of similarities and differences in outreach methods (e.g., peer workers, time of outreach, etc.), geographic settings (i.e., mobile van, institutional settings, community locations), individual characteristics (e.g., pregnant women) and youth subcultures (i.e., gay/transgendered, incarcerated juveniles, homeless). CONCLUSIONS: Because HIV-positive adolescents will constitutionally remain a "hidden population," a great deal of time and effort will continue to need to go into the front end of outreach, counseling and testing. Specific guidance and recommendations for locating HIV-positive youth were provided to program designers for each type of outreach strategy.

Transitioning youths into care: linking identified HIV-infected youth at outreach sites in the community to hospital-based clinics and or community-based health centers.

PURPOSE: To describe and analyze the process of transitioning HIV-infected youths from the point of HIV diagnosis into HIV treatment. Rather than simply offering HIV positive youths a list of referrals, the youth-focused SPNS grantees (AWAC) found it vital that youths were immediately assisted with linkage to a medical provider. METHODS: From February 1997 to December 2000, 107 identified HIV-infected youths from the five adolescent SPNS projects were surveyed on needs and barriers. The time interval between HIV testing and youth linkage to care was also noted. RESULTS: Nine percent of youth reported perceived barriers to accessing health care. Perceived needs were identified as Mental Health (44.9%; n = 48); Alcohol and drug treatment (14%; n = 15); transportation to health care settings (40.2%; n = 43); and housing (46.7%; N = 50). At sites tracking linkage to care, the time of being transitioned into a medical setting ranged from 5 to 55 days (average 26 days). CONCLUSIONS: The period of transitioning identified HIV-infected youths into care can be reduced from 1-5 years to as short as 5-55 days. Success with linking these youth to care involves establishing a series of contacts at outreach sites wherein program staff seeks to build trusting relationships with youths, is able to track these youths and identify and address perceived needs.

The utilization of treatment and case management services by HIV-infected youth.

PURPOSE: This article describes the essential components for effective and comprehensive HIV care for youth who have tested positive and have been linked to HIV treatment. Descriptive profile data are also presented that detail the demographics, risk behaviors and health care barriers of youth served in the five Special Projects of National Significance (SPNS), which focused on adolescents and young adults. METHODS: Data presented are from the core multi-site data set, which was standardized across the five youth-oriented SPNS projects. Substance use and mental health symptoms were gathered using the Personal Problem Questionnaire (PPQ) screener, which was an adaptation of the PRIME-MD. In-depth qualitative interviews with enrolled HIV-positive youth were also conducted by several Projects. RESULTS AND CONCLUSIONS: Medical care alone is not enough and cannot be effective without supportive program components such as flexible scheduling, and a multi-disciplinary team approach that includes assertive case management. Case Managers help enrolled youth with concrete service needs such as housing, emergency financial assistance for food/utilities, transportation, child care, coverage for prescriptions, and public entitlements. They also help isolated youth to connect with a personal support system. Addressing those needs helps to facilitate and reinforce treatment adherence and retention. In addition to other identified needs such as stable housing and transportation, a significant number of enrolled youth self-reported having experienced physical, sexual, and/or emotional abuse in their lives and articulated a need for mental health services. Therefore, effective HIV care for youth must be multi-faceted; it must consist of more than a medical component.

Retention, adherence, and compliance: special needs of HIV-infected adolescent girls and young women.

PURPOSE: To demonstrate that whereas all HIV-infected youth evidence complex factors that challenge retention in care and adherence to treatment, HIV-infected females have additional issues that are gender-specific. METHODS: Preliminary data from a subset of 21 adolescent/young women under age 25 from the Whole Life mental health-perinatal HIV care project were analyzed to illustrate the needs of these patients. RESULTS: Of the 21 young women assessed, all but one was of minority background, and a sizeable majority had limited education (

Making waves: systems change on behalf of youth with HIV/AIDS.

PURPOSE: To document the effects of five Special Projects of National Significance (SPNS), funded by the Health Resources and Services Administration (HRSA), on HIV care, related service systems, policy, planning, and funding for youth with HIV/AIDS. METHODS: Literature on services and systems integration and technology transfer is used as a conceptual framework for the examination of HIV-informed, youth-specific changes at the local, state, and national levels. The Principal Investigators for each project and/or the Project Evaluators were interviewed several times to capture "snapshots" of evolving results from the Projects' varied activities in New York City; Newark, New Jersey; Chicago; and Miami. Some changes were consciously targeted, and others occurred serendipitously. This work covers the funding period from 1996 through 2000. RESULTS AND CONCLUSIONS: There were many "ripple" effects that emanated from these Projects' presence and activities. Important lessons were learned about why systems change is necessary to effectively serve youth with HIV, how to make constructive changes happen, and how to sustain changes once they are achieved. Successful strategies included, but were not limited to, consensus-building among stakeholders, participatory planning and decision-making, collaborative referral and linkage agreements, staff sharing, co-locating services, providing technical assistance, consultation, cross-training, and engaging consumers as partners in communicating new technologies and in advocating for change.

The reciprocal effects of program evaluation on service delivery for the SPNS adolescent HIV outreach and treatment programs.

PURPOSE: To describe the contexts within which the Special Projects of National Significance (SPNS) Adolescent HIV Outreach and Treatment programs were evaluated, the effects their evaluations had on their respective programs and, in turn, the effects the program delivery had on the evaluations. METHODS: The full range of process evaluation heuristics were used to analyze the bi-directional effects of conducting field-based, service delivery data collection. Although data collection efforts sometimes interfered with service delivery, and vice versa, several notable positive effects were disclosed. CONCLUSIONS: Specific guidance and recommendations were provided to program designers, behavioral researchers and institutional funding decision makers. Primary amongst them was a call for research evaluation designs that allow for maximum flexibility.

Tuberculosis skin testing among HIV-infected pregnant women in Miami, 1995 to 1996.

OBJECTIVE: Approximately 6000 women deliver annually at Jackson Memorial Hospital in Miami, where 2.4% of women has human immunodeficiency virus (HIV) and 60% is foreign-born. We conducted a retrospective review of prenatal records among HIV-infected women to evaluate tuberculin skin testing (TST). STUDY DESIGN: We determined how many women had TSTs placed and read, and the TST results. RESULTS: We identified 207 HIV-infected women, 87% of such women delivering in 1995 to 1996. Most did not know their HIV status before seeking prenatal care (109, 54%) and most (176, 85%) had TSTs done. Of the women, 45 had positive TSTs, 96 had negative TSTs, and 35 were anergic. Most results were not recorded using millimeters of induration. Two women (1%) had active tuberculosis (TB) disease. CONCLUSION: Overall, 21% of all HIV-infected women had positive TSTs and 1% had active TB disease. Focused TB skin testing should be part of routine prenatal care in clinics serving populations at high-risk for TB, such as those with HIV infection and the foreign-born.