NRG-CC004 ancillary data study-exploring the effect of bupropion on sexual desire in female cancer survivors with and without vulvovaginal symptoms.

BACKGROUND: Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns. AIM: The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo. METHODS: Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates. OUTCOMES: The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9 weeks. RESULTS: Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire. CLINICAL IMPLICATIONS: Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention. STRENGTHS AND LIMITATIONS: This secondary analysis was not powered to examine all variables. CONCLUSION: Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire.

The experience of women in a phase II trial of hypnosis and progressive muscle relaxation for body image: informing future research questions.

This study examines feedback from two interventions, hypnosis and progressive muscle relaxation (PMR), to improve body image in a randomized phase II trial. Eighty-seven women were randomized either to hypnosis or PMR. Sixty-three women (72%) were motivated to write comments about their study experience. These comments were explored in an unplanned qualitative analysis. Thematic analysis generated five themes, suggesting both hypnosis and PMR may improve body image through the ability to relax and manage stress, sleep better, improve mood and create a mind-body connection. Sexual health emerged as a theme for participants in only the hypnosis group which suggests hypnotic suggestions for body image may improve overall sexual health. Additional research is needed to assess this further.

Reaching Populations to Address Disparities in Cancer Care Delivery: Results From a Six-Site Initiative.

BACKGROUND: Large segments of the US population do not receive quality cancer care due to pervasive and systemic inequities, which can increase morbidity and mortality. Multicomponent, multilevel interventions can address inequities and improve care, but only if they reach communities with suboptimal access. Intervention studies often underenroll individuals from historically excluded groups. METHODS: The Alliance to Advance Patient-Centered Cancer Care includes 6 grantees across the United States who implemented unique multicomponent, multilevel intervention programs with common goals of reducing disparities, increasing engagement, and improving the quality of care for targeted populations. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the evaluation efforts across sites. Each Alliance site identified their intended populations, which included underrepresented minorities (eg, Black and Latinx persons), individuals who prefer a language other than English, and rural residents. We evaluated the demographic characteristics of participants to determine program reach. RESULTS: Between 2018 and 2020, a total of 2,390 of 5,309 potentially eligible participants were enrolled across the 6 sites. The proportion of enrolled individuals with selected characteristics included 38% (n=908) Black adults, 24% (n=574) Latinx adults, 19% (n=454) preferring a language other than English, and 30% (n=717) rural residents. The proportion of those enrolled who were the intended population was commensurate to the proportion with desired characteristics in those identified as potentially eligible. CONCLUSIONS: The grantees met or exceeded enrollments from their intended populations who have been underserved by quality cancer care into patient-centered intervention programs. Intentional application of recruitment/engagement strategies is needed to reach individuals from historically underserved communities.

Trends in integrative medicine and health consults: differences between cancer survivors and patients without cancer.

OBJECTIVES: The objectives were to compare patients with and without cancer who sought an integrative health (IH) consult and reasons for seeking a consult. DESIGN: Descriptive cross-sectional study that employed a secondary analysis of an integrative health database supplemented by a retrospective medical record review. SETTING/LOCATION: Integrative Medicine and Health program in a Southwestern United States academic medical center. SUBJECTS: Eight hundred thirty-nine adults over the age of 18 seeking IH consultation. RESULTS: The number of complementary therapies reported prior to consult were not significantly different between groups. The most reported complementary therapies used by cancer survivors were multivitamins, exercise, and turmeric. Patients without cancer reported significantly higher pain levels than cancer survivors. Cancer survivors reported significantly higher energy, sleep levels, overall health, spiritual wellbeing, and significantly better relationships compared to patients without cancer. Cancer survivors reported fatigue and cancer as the top reasons for IH consult. CONCLUSION: Participants without cancer reported higher levels of pain and lower levels of energy, sleep, overall health, spiritual wellbeing, and relationships compared to cancer survivors. However, cancer survivors still reported levels of unmanaged symptoms. Complementary therapy use prior to IMH consult was similar between groups; however, IMH providers recommended more treatments for patients without cancer. Our results highlight that more evidence is needed to guide IMH recommendations, especially for cancer survivors who may still be in treatment. Additionally, our results support evidence-based recommendations that all cancer survivors should be assessed for complementary therapy use and provided counseling by qualified providers on their advantages and limitations.

Mi Sleep Coach Mobile App to Address Insomnia Symptoms Among Cancer Survivors: Single-Arm Feasibility Study.

BACKGROUND: Rates of sleep disturbance among survivors of cancer are more than 3 times higher than the general population. Causes of sleep disturbance among survivors are many and multifaceted, including anxiety and fear related to cancer diagnosis and treatments. Cognitive behavioral therapy for insomnia (CBT-I) is considered a first-line treatment for insomnia; However, a lack of access to trained professionals and limited insurance coverage for CBT-I services has limited patient access to these effective treatments. Evidence supports digital delivery of CBT-I (dCBT-I), but there is only limited evidence to support its use among survivors of cancer. Broad adoption of smartphone technology provides a new channel to deliver dCBT-I, but no prior studies have evaluated mobile dCBT-I interventions for survivors. To address the need for accessible and efficacious CBT-I for survivors of cancer, the Mi Sleep Coach program was developed to adapt CBT-I for delivery to survivors of cancer as a self-directed mobile health app. OBJECTIVE: This single-arm feasibility study assessed the adherence, attrition, usefulness, and satisfaction of the Mi Sleep Coach app for insomnia. METHODS: A 7-week, single-arm study was conducted, enrolling adult survivors of breast, prostate, or colon cancer reporting sleep disturbances. RESULTS: In total, 30 participants were enrolled, with 100% completing the study and providing data through week 7. Further, 9 out of 10 app features were found to be useful by 80% (n=24) to 93% (n=28) of the 30 participants. Furthermore, 27 (90%) participants were satisfied with the Mi Sleep Coach app and 28 (93%) would recommend the use of the Mi Sleep Coach app for those with insomnia. The Insomnia Severity Index showed a decrease from baseline (18.5, SD 4.6) to week 7 (10.4, SD 4.2) of 8.1 (P<.001; Cohen d=1.5). At baseline, 25 (83%) participants scored in the moderate (n=19; 15-21) or severe (n=6; 22-28) insomnia range. At week 7, a total of 4 (13%) patients scored in the moderate (n=4) or severe (n=0) range. The number of patients taking prescription sleep medications decreased from 7 (23%) at baseline to 1 (3%; P<.001) at week 7. The number of patients taking over-the-counter sleep medications decreased from 14 (47%) at baseline to 9 (30%; P=.03) at week 7. CONCLUSIONS: The Mi Sleep Coach app demonstrated high levels of program adherence and user satisfaction and had large effects on the severity of insomnia among survivors of cancer. The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted. If proven to significantly decrease insomnia in survivors of cancer in future randomized controlled clinical trials, this intervention would provide more survivors of cancer with easy access to evidence-based CBT-I treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04827459; https://clinicaltrials.gov/study/NCT04827459.

Clinical Practice Strategies to Address Sexual Health in Female Cancer Survivors.

PURPOSE: The objectives of this narrative review are to describe (1) the evidence for interventions addressing four key issues affecting female sexual health in cancer populations (ie, low sexual desire, vulvovaginal symptoms, negative body image, and sexual partner relationships) that are ready or nearly ready for integration into practice and (2) the current state of patient-provider sexual health communication related to female sexual health as these findings could have implications for integrating sexual health into practice. METHODS: A narrative review of recent intervention evidence for female cancer survivors' sexual health was conducted. RESULTS: Strong evidence was found for behavioral interventions, such as psychosexual counseling and psychoeducation to treat concerns related to sexual health, including desire, body image, and sexual partner relationships. For partnered female survivors, couple-based psychosexual interventions have been found to be effective. There are no proven pharmacologic treatments for sexual-related concerns other than for vulvovaginal atrophy in female cancer survivors. Vaginal nonhormonal and low-dose hormonal agents are effective remedies for vulvovaginal symptoms. Laser treatment has not yet been fully evaluated. Sexual partners are a critical context for sexual health. Despite much need, discussions around this topic continue to be relatively infrequent. Recent technology-based interventions show promise in improving discussions around sexual health. CONCLUSION: Effective interventions exist for many sexual health challenges for female survivors although more high-quality intervention research, particularly multimodal interventions, is needed. Many of the effective interventions are nonpharmacologic, and thus, evaluation of the use of digital delivery to improve access to these interventions is needed. Cancer care delivery research is urgently needed to translate existing effective interventions into practice, including strategies to improve patient-provider communication around this topic.

A Scoping Review of Strategies to Increase Black Enrollment and Retention in Cancer Clinical Trials.

To address health disparities faced by Black patients with cancer, it is critical that researchers conducting cancer clinical trials (CCTs) equitably recruit and retain Black participants, develop strategies toward this aim, and document associated outcomes. This narrative scoping literature review, as part of a larger study, aimed to identify, describe, and categorize strategies and interventions intended to improve the recruitment and retention of Black participants with breast, lung, prostate, colorectal, or multiple myeloma cancer into CCTs. We conducted comprehensive searches in PubMed, Embase, Cochrane Library, PsycInfo, CINAHL, Scopus, and Web of Science with three main concepts: Black persons, neoplasms, and clinical trial recruitment. The search resulted in 1,506 articles, of which 15 met inclusion criteria. Five main categories of recruitment and retention strategies and interventions were identified based on their specific population focus and type of approach: (1) participant identification, (2) provider awareness/resources, (3) focused research staff interventions, (4) patient and community-focused awareness strategies, and (5) participant-directed resources. Thirteen studies had recruitment acceptance rates of over 30%. Eight studies with acceptance rates of ≥ 50% reported implementing ≥ 5 strategies, with an average use of seven strategies across multiple categories. Five studies with acceptance rates ≥ 50% implemented strategies in ≥ 3 categories. Four studies reported retention rates ≥ 74%. Three studies with reported retention rates ≥ 74% used strategies in ≥ 3 categories, and all included strategies aimed at meeting participant needs beyond the study. Our results show that many efforts that aim to increase the recruitment and retention of Black participants into CCTs have great potential, but the most promising strategies use a multiprong approach.

Feasibility of Attention Restoration Theory-Driven Hypnotherapy for Fatigue in Cancer Survivors.

This study aimed to assess the feasibility of Attention Restoration Theory (ART)-driven hypnotherapy to address cancer-related fatigue (CRF). Six participants with CRF completed the study. Participants completed measures of fatigue and pain pre- and posttreatment of 5 sessions of ART-driven hypnotherapy, each of which followed a treatment manual. Results indicate that participants experienced reductions in fatigue, fatigue bothersomeness, and pain following the intervention. Additionally, participants reported high levels of treatment satisfaction. This innovative intervention of ART-driven hypnotherapy appears to be feasible and warrants further study in a controlled trial with a larger sample.

Cautionary study on the effects of pay for performance on quality of care: a pilot randomised controlled trial using standardised patients.

BACKGROUND: Due to the difficulty of studying incentives in practice, there is limited empirical evidence of the full-impact pay-for-performance (P4P) incentive systems. OBJECTIVE: To evaluate the impact of P4P in a controlled, simulated environment. DESIGN: We employed a simulation-based randomised controlled trial with three standardised patients to assess advanced practice providers' performance. Each patient reflected one of the following: (A) indicated for P4P screenings, (B) too young for P4P screenings, or (C) indicated for P4P screenings, but screenings are unrelated to the reason for the visit. Indication was determined by the 2016 Centers for Medicare and Medicaid Services quality measures. INTERVENTION: The P4P group was paid $150 and received a bonus of $10 for meeting each of five outcome measures (breast cancer, colorectal cancer, pneumococcal, tobacco use and depression screenings) for each of the three cases (max $300). The control group received $200. SETTING: Learning resource centre. PARTICIPANTS: 35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters. MEASUREMENTS: Adherence to incentivised outcome measures, interpersonal communication skills, standards of care, and misuse. RESULTS: The Type a patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027). The Type b patient was more likely to be prescribed screenings not indicated, but highlighted by P4P: breast cancer screening (47% P4P vs 0% control, p<0.01) and colorectal cancer screening (24% P4P vs 0% control, p=0.03). The P4P group over-reported completion of incentivised measures resulting in overpayment (average of $9.02 per patient). LIMITATIONS: A small sample size and limited variability in patient panel limit the generalisability of findings. CONCLUSIONS: Our findings caution the adoption of P4P by highlighting the unintended consequences of the incentive system.

Integrative Therapies for Cancer-Related Fatigue.

Cancer-related fatigue (CRF) is a common symptom for which cancer patients often use integrative and integrative therapies; however, evidence supporting these therapies is limited. The aim of this review is to provide evidence-based recommendations for integrative interventions during and after cancer treatment for CRF. These recommendations are based on a systematic literature review from 1990 through 2019. Cognitive behavior therapy plus hypnosis and American ginseng can be considered during active treatment, and acupressure, mindfulness-based cognitive therapy, and qigong/tai chi easy can be considered during posttreatment. Coenzyme Q10 and L-carnitine are not recommended during active-treatment. All other integrative therapies for CRF had insufficient evidence to make a recommendation. While there is increasing evidence for integrative therapies for CRF, because of lack of rigorous trials and replication, no therapies could be definitively recommended. Further rigorously designed integrative therapy research is needed and should consider implementation and dissemination.

Ginseng as a Treatment for Fatigue: A Systematic Review.

BACKGROUND: Millions of people with chronic illness suffer from fatigue. Fatigue is a complex, multidimensional symptom with poorly understood causes, wide variations in severity among individuals, and negative effects on multiple domains of daily life. Many patients with fatigue report the use of herbal remedies. Ginseng is one of the most widely used because it is believed to improve energy, physical and emotional health, and well-being. OBJECTIVE: To systematically review the published evidence to evaluate the safety and effectiveness of the two types of Panax ginseng (Asian [Panax ginseng] and American [Panax quinquefolius]) as treatments for fatigue. DESIGN: PubMed, CINAHL (Cumulative Index to Nursing and Allied Health), Ovid MEDLINE, and EMBASE databases were searched using Medical Subject Heading and keyword terms, including ginseng, Panax, ginsenosides, ginsenoside* (wild card), fatigue, fatigue syndrome, cancer-related fatigue, and chronic fatigue. Studies were included if participants had fatigue, had used one of the two Panax ginsengs as an intervention, and had scores from a self-report fatigue measure. Two reviewers independently assessed each article at each review phase and met to develop consensus on included studies. Risk of bias was assessed using version 5.3 of the Cochrane Collaboration Review Manager (RevMan), and results were synthesized in a narrative summary. RESULTS: The search strategy resulted in 149 articles, with 1 additional article located through review of references. After titles, abstracts, and full text were reviewed, 139 articles did not meet inclusion criteria. For the 10 studies reviewed, there was a low risk of adverse events associated with the use of ginseng and modest evidence for its efficacy. CONCLUSIONS: Ginseng is a promising treatment for fatigue. Both American and Asian ginseng may be viable treatments for fatigue in people with chronic illness. Because of ginseng's widespread use, a critical need exists for continued research that is methodologically stronger and that includes more diverse samples before ginseng is adopted as a standard treatment option for fatigue.

Team Cognition As a Means to Improve Care Delivery in Critically Ill Patients With Cancer After Hematopoietic Cell Transplantation.

Hematopoietic cell transplantation (HCT) is an important and complex treatment modality for a variety of hematologic malignancies and some solid tumors. Although outcomes of patients who have undergone HCT and require care in intensive care units (ICUs) have improved over time, mortality rates remain high and there are significant associated costs. Lack of a team-based approach to care, especially during critical illness, is detrimental to patient autonomy and satisfaction, and to team morale, ultimately leading to poor quality of care. In this manuscript, we describe the case of a patient who had undergone HCT and was in the ICU setting, where inconsistent team interaction among the various stakeholders delivering care resulted in a lack of shared goals and poor outcomes. Team cognition is cognitive processing at the team level through interactions among team members and is reflected in dynamic communication and coordination behaviors. Although the patient received multidisciplinary care as needed in a medically complicated case, a lack of team cognition and, particularly, inconsistent communication among the dynamic teams caring for the patient, led to mixed messages being delivered with high-cost implications for the health-care system and the family. This article highlights concepts and recommendations that begin a necessary in-depth assessment of implications for clinical care and initiate a research agenda that examines the effects of team cognition on HCT teams, and, more generally, critical care of the patient with cancer.