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.

Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.

PURPOSE: To update the ASCO guideline on the management of cancer-related fatigue (CRF) in adult survivors of cancer. METHODS: A multidisciplinary panel of medical oncology, geriatric oncology, internal medicine, psychology, psychiatry, exercise oncology, integrative medicine, behavioral oncology, nursing, and advocacy experts was convened. Guideline development involved a systematic literature review of randomized controlled trials (RCTs) published in 2013-2023. RESULTS: The evidence base consisted of 113 RCTs. Exercise, cognitive behavioral therapy (CBT), and mindfulness-based programs led to improvements in CRF both during and after the completion of cancer treatment. Tai chi, qigong, and American ginseng showed benefits during treatment, whereas yoga, acupressure, and moxibustion helped to manage CRF after completion of treatment. Use of other dietary supplements did not improve CRF during or after cancer treatment. In patients at the end of life, CBT and corticosteroids showed benefits. Certainty and quality of evidence were low to moderate for CRF management interventions. RECOMMENDATIONS: Clinicians should recommend exercise, CBT, mindfulness-based programs, and tai chi or qigong to reduce the severity of fatigue during cancer treatment. Psychoeducation and American ginseng may be recommended in adults undergoing cancer treatment. For survivors after completion of treatment, clinicians should recommend exercise, CBT, and mindfulness-based programs; in particular, CBT and mindfulness-based programs have shown efficacy for managing moderate to severe fatigue after treatment. Yoga, acupressure, and moxibustion may also be recommended. Patients at the end of life may be offered CBT and corticosteroids. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of CRF. There is insufficient evidence to make recommendations for or against other psychosocial, integrative, or pharmacological interventions for the management of fatigue.Additional information is available at www.asco.org/survivorship-guidelines.

Exploring Adolescent and Young Adult Cancer Survivors' Experience with Cancer Treatment-Related Symptoms: A Qualitative Analysis of Semi-Structured Interviews.

Purpose: Few studies have specifically targeted symptom management interventions for adolescent and young adult (AYA) cancer survivors. A greater understanding of AYA cancer survivors' experiences with cancer treatment-related symptoms would help develop age-appropriate oncology symptom management interventions. The purpose of this qualitative analysis was to explore AYA cancer survivors' experience with cancer treatment-related symptoms. Methods: Nineteen post-treatment AYA cancer survivors (18-39 years old) who self-reported moderate-severe cancer treatment-related symptom severity participated in video conferencing or telephone interviews. The questions in the interview guide queried participants to share their experience with cancer treatment-related symptoms. Inductive content analysis was used to identify themes from the interviews. Results: The themes that emerged from the interviews included (1) cancer treatment-related symptoms negatively affected AYA cancer survivors' quality of life (e.g., symptoms served as a reminder of cancer recurrence possibility); (2) AYA cancer survivors' attitudes and feelings about communicating cancer treatment-related symptom concerns to clinicians (e.g., patient-clinician communication was bolstered when AYAs perceived that symptoms were being taken seriously); (3) AYA cancer survivors are interested in oncology symptom management clinical trials, but logistical challenges are barriers to participation; and (4) AYA cancer survivors are interested in nonpharmacological treatments for symptom management. Conclusion: Results highlight the burden of cancer treatment-related symptoms on day-to-day life among post-treatment AYA cancer survivors. Future work is needed to identify nonpharmacological symptom management interventions, strategies to improve patient-clinician communication about symptoms, and strategies to increase the visibility and accessibility of symptom management clinical trials for AYA cancer survivors.

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.

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.

A pilot randomized, placebo-controlled, double-blind study of omega-3 fatty acids to prevent paclitaxel-associated acute pain syndrome in breast cancer patients: Alliance A22_Pilot2.

PURPOSE: Paclitaxel is associated with an acute pain syndrome (P-APS- and chronic chemotherapy-induced peripheral neuropathy (CIPN). P-APS is associated with higher risk of CIPN. Omega-3 fatty acids have well-established anti-inflammatory and neuroprotective properties. The primary purpose of this pilot study was to assess whether omega-3 fatty acids could decrease P-APS and thus CIPN. METHODS: Patients scheduled to receive weekly paclitaxel for breast cancer were randomized to receive 4 g of omega-3 acid ethyl esters (Lovaza) or placebo, beginning 1 week prior and continued until paclitaxel was stopped. Patients completed acute pain questionnaires at baseline, daily after each treatment, and 1 month after completion of therapy. RESULTS: Sixty patients (49 evaluable) were randomized to treatment versus placebo. Seventeen (68.0%) patients receiving the omega-3 fatty acids intervention experienced P-APS, compared to 15 (62.5%) of those receiving placebo during the first week of treatment (p = 0.77). Over the full 12-week study, 21 (84.0%) patients receiving the omega-3 fatty acid intervention experienced P-APS, compared to 21 (87.5%) of those receiving placebo (p = 1.0). Secondary outcomes suggested that those in the intervention arm used more over-the-counter analgesics (OR: 1.65, 95% CI: 0.72-3.78, p = 0.23), used more opiates (OR: 2.06, 95% CI: 0.55-7.75, p = 0.28), and experienced higher levels of CIPN (12.8, 95% CI: 7.6-19.4 vs. 8.4, 95% CI: 4.6-13.2, p = 0.21). CONCLUSIONS: The results of this pilot study do not support further study of the use of omega-3 fatty acids for the prevention of the P-APS and CIPN. TRIAL REGISTRATION: Number: NCT01821833.

A descriptive study of policy and system-level interventions to address cancer survivorship issues across six United States health systems.

PURPOSE: To describe policy and system-level interventions with potential to improve cancer care at six sites. METHODS: In 2016, six institutions received foundation support to develop unique multi-component interventions aimed at improving cancer care for underserved populations. These organizations, located across the United States, participated in a cross-site evaluation to assess the overall initiative impact and to identify potentially promising policy and system-level solutions for dissemination and broader implementation. A health system and policy tracking tool was developed to collect data from each site and included a description of their efforts, strategies employed, and changes achieved (e.g., new policies, clinical protocols). Tracking tool data were analyzed using rapid qualitative analyses and a matrix approach. Semi-structured interviews were conducted with site leaders (N = 65) and were analyzed by thematic analysis. RESULTS: Sites reported 20 system and policy efforts, which resulted in improvements to electronic health records and telehealth strategies, changes to hospital/health system policies, and standardized clinical protocols/guidelines, among others. Efforts were aimed at: (1) coordinating care across multiple providers, supported by patient navigators; (2) expanding psychosocial and supportive care; (3) improving patient-provider communication; and (4) addressing barriers to accessing care. Interview analyses provided insights into successful strategies, challenges, and implications of the COVID-19 pandemic on cancer care. CONCLUSIONS AND IMPLICATIONS FOR CANCER SURVIVORS: Despite advances in diagnosis and treatment, cancer care remains inequitable. System-level improvements aimed at eliminating common barriers faced by underserved populations offer opportunities to improve the delivery of equitable, effective, and efficient care.

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.

Self-Management Energy Conservation for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study.

OBJECTIVES: To examine the adherence to and the usefulness, satisfaction, and preliminary efficacy of a 12-week self-management energy conservation and active management intervention on fatigue. SAMPLE & SETTING: A total of 19 Thai women diagnosed with stage I-III breast cancer receiving adjuvant chemotherapy were enrolled from a local hospital in the central region of Thailand. METHODS & VARIABLES: A randomized controlled trial design was used. Fatigue was measured using the Piper Fatigue Scale-Revised and was collected at baseline and 12 weeks. Descriptive statistics and Student's t tests were used to analyze the data. RESULTS: Participants completed four interventional sessions. Of participants in the experimental group, nine were satisfied with the intervention, seven were satisfied with its effects on fatigue, and seven were very satisfied with the telephone delivery. Participants in the experimental group reported significantly less fatigue at 12 weeks compared to the attention control group (p = 0.008). IMPLICATIONS FOR NURSING: Teaching energy conservation principles and strategies to women with breast cancer undergoing chemotherapy is an intervention oncology nurses can easily deliver.

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.

A pilot intervention of using a mobile health app (ONC Roadmap) to enhance health-related quality of life in family caregivers of pediatric patients with cancer.

Background: The Roadmap mobile health (mHealth) app was developed to provide health-related quality of life (HRQOL) support for family caregivers of patients with cancer. Methods: Eligibility included: family caregivers (age ≥18 years) who self-reported as the primary caregiver of their pediatric patient with cancer; patients (age ≥5 years) who were receiving cancer care at the University of Michigan. Feasibility was calculated as the percentage of caregivers who logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the 120-day study duration. Feasibility and acceptability was also assessed through a Feasibility and Acceptability questionnaire and the Mobile App Rating Scale to specifically assess app-quality. Exploratory analyses were also conducted to assess HRQOL self- or parent proxy assessments and physiological data capture. Results: Between September 2020-September 2021, 100 participants (or 50 caregiver-patient dyads) consented and enrolled in the ONC Roadmap study for 120-days. Feasibility of the study was met, wherein the majority of caregivers (N=32; 65%) logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the study duration (defined a priori in the Protocol). The Feasibility and Acceptability questionnaire responses indicated that the study was feasible and acceptable with the majority (>50%) reporting Agree or Strongly Agree with positive Net Favorability [(Agree + Strongly Agree) - (Disagree + Totally Disagree)] in each of the domains (e.g., Fitbit use, ONC Roadmap use, completing longitudinal assessments, engaging in similar future study, study expectations). Improvements were seen across the majority of the mental HRQOL domains across all groups; even though underpowered, there were significant improvements in caregiver-specific aspects of HRQOL and anxiety and in depression and fatigue for children (ages 8-17 years), and a trend toward improvement in depression for children ages 8-17 years and in fatigue for adult patients. Conclusions: This study supports that mHealth technology may be a promising platform to provide HRQOL support for caregivers of pediatric patients with cancer. Importantly, the findings suggest that the study protocol was feasible, and participants were favorable to participate in future studies of this intervention alongside routine cancer care delivery.

Assessing Physical and Cognitive Function in Individuals With Head and Neck Cancer: A Feasibility Study.

BACKGROUND: Head and neck cancer (HNC) and associated treatments have significant long-term and late adverse effects that can impair function. Therefore, there is a need for reliable common metrics to assess function in HNC that limit participant burden and are cost-effective and easy to use in clinical settings. OBJECTIVE: The aim of this study was to assess the feasibility of using the Fitbit Zip, NIH Toolbox, and REDCap electronic data collection tool to measure function and symptoms in individuals with HNC and to explore preliminary findings. METHODS: A prospective descriptive design with a total of 16 participants was used to assess function and symptoms pretreatment to 3 months post treatment initiation. RESULTS: The enrollment rate was 49%, the retention rate was 81%, and the Fitbit Zip adherence rate was 86%. Exploratory analyses suggested a possible decline in physical activity and worsening symptom burden alongside improved attention and cognitive flexibility abilities ( P ≤ .05). There were no differences in strength, functional mobility, information processing, or perceived attentional function. CONCLUSION: The results of this study suggest that use of the Fitbit Zip, NIH Toolbox, and REDCap data collection tool in HNC is feasible. Exploratory analyses suggest that the Fitbit Zip may be a sensitive measure of physical activity in HNC. IMPLICATIONS FOR PRACTICE: This study provides preliminary evidence for metrics that could be used in the clinical settings to assess function and symptom distress in HNC. Integration of these measures, upon further validation, could help providers better identify patients in need of intervention.

Use of Opioids for Adults With Pain From Cancer or Cancer Treatment: ASCO Guideline.

PURPOSE: To provide guidance on the use of opioids to manage pain from cancer or cancer treatment in adults. METHODS: A systematic review of the literature identified systematic reviews and randomized controlled trials of the efficacy and safety of opioid analgesics in people with cancer, approaches to opioid initiation and titration, and the prevention and management of opioid adverse events. PubMed and the Cochrane Library were searched from January 1, 2010, to February 17, 2022. American Society of Clinical Oncology convened an Expert Panel to review the evidence and formulate recommendations. RESULTS: The evidence base consisted of 31 systematic reviews and 16 randomized controlled trials. Opioids have primarily been evaluated in patients with moderate-to-severe cancer pain, and they effectively reduce pain in this population, with well-characterized adverse effects. Evidence was limited for several of the questions of interest, and the Expert Panel relied on consensus for these recommendations or noted that no recommendation could be made at this time. RECOMMENDATIONS: Opioids should be offered to patients with moderate-to-severe pain related to cancer or active cancer treatment unless contraindicated. Opioids should be initiated PRN (as needed) at the lowest possible dose to achieve acceptable analgesia and patient goals, with early assessment and frequent titration. For patients with a substance use disorder, clinicians should collaborate with a palliative care, pain, and/or substance use disorder specialist to determine the optimal approach to pain management. Opioid adverse effects should be monitored, and strategies are provided for prevention and management.Additional information is available at www.asco.org/supportive-care-guidelines.

Tolerance to oral anticancer agent treatment in older adults with cancer: a secondary analysis of data from electronic health records and a pilot study of patient-reported outcomes.

BACKGROUND: More than 60% of cancer cases occur in older adults, and many are treated with oral anticancer agents. Yet, the treatment tolerability in older adults has not been fully understood due to their underrepresentation in oncology clinical trials, creating challenges for treatment decision-making and symptom management. The objective of this study was to investigate the tolerance of capecitabine, an example of oral chemotherapy, among older adults with cancer and explore factors associated with capecitabine-related side effects and treatment changes, to enhance supportive care. METHODS: A secondary analysis used combined data from electronic health records and a pilot study of patient-reported outcomes, with a total of 97 adult patients taking capecitabine during 2016-2017, including older adult patients aged 65 years or older (n = 43). The data extracted included patient socio-demographics, capecitabine information, side effects, and capecitabine treatment changes (dose reductions and dose interruptions). Bivariate correlations, negative binomial regression, and multiple linear regression were conducted for data analysis. RESULTS: Older adults were more likely to experience fatigue (86% vs. 51%, p = .001) and experienced more severe fatigue (ß = 0.44, p = 0.03) and hand-foot syndrome (HFS) (ß = 1.15, p = 0.004) than younger adults. The severity of fatigue and HFS were associated with the number of outpatient medications (ß = 0.06, p = 0.006) and the duration of treatment (ß = 0.50, p = 0.009), respectively. Correlations among side effects presented different patterns between younger and older adults. Although more older adults experienced dose reductions (21% vs. 13%) and dose interruptions (33% vs. 28%) than younger adults, the differences were not statistically different. Female sex, breast cancer diagnosis, capecitabine monotherapy, and severe HFS were found to be associated with dose reductions (p-values < 0.05). CONCLUSIONS: Older adults were less likely to tolerate capecitabine treatment and had different co-occurring side effects compared to younger adults. While dose reductions are common among older adults, age 65 years or older may not be an independent factor of treatment changes. Other socio-demographic and clinical factors may be more likely to be associated. Future studies can be conducted to further explore older adults' tolerance to a variety of oral anticancer agents to generate more evidence to support optimal treatment decision-making and symptom management.

Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline.

PURPOSE: The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other health care providers on integrative approaches to managing pain in patients with cancer. METHODS: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2021. Outcomes of interest included pain intensity, symptom relief, and adverse events. Expert panel members used this evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS: The literature search identified 227 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS: Among adult patients, acupuncture should be recommended for aromatase inhibitor-related joint pain. Acupuncture or reflexology or acupressure may be recommended for general cancer pain or musculoskeletal pain. Hypnosis may be recommended to patients who experience procedural pain. Massage may be recommended to patients experiencing pain during palliative or hospice care. These recommendations are based on an intermediate level of evidence, benefit outweighing risk, and with moderate strength of recommendation. The quality of evidence for other mind-body interventions or natural products for pain is either low or inconclusive. There is insufficient or inconclusive evidence to make recommendations for pediatric patients. More research is needed to better characterize the role of integrative medicine interventions in the care of patients with cancer.Additional information is available at https://integrativeonc.org/practice-guidelines/guidelines and www.asco.org/survivorship-guidelines.

Implementing patient navigation programs: Considerations and lessons learned from the Alliance to Advance Patient-Centered Cancer Care.

BACKGROUND: Six multidisciplinary cancer centers were selected and funded by the Merck Foundation (2017-2021) to collaborate in the Alliance to Advance Patient-Centered Cancer Care ("Alliance"), an initiative to improve patient access, minimize health disparities, and enhance the quality of patient-centered cancer care. These sites share their insights on implementation and expansion of their patient navigation efforts. METHODS: Patient navigation represents an evidence-based health care intervention designed to enhance patient-centered care and care coordination. Investigators at 6 National Cancer Institute-designated cancer centers outline their approaches to reducing health care disparities and synthesize their efforts to ensure sustainability and successful transferability in the management of patients with cancer and their families in real-world health care settings. RESULTS: Insights are outlined within the context of patient navigation program effectiveness and supported by examples from Alliance cancer center sites: 1) understand the patient populations, particularly underserved and high-risk patients; 2) capitalize on the existing infrastructure and institutional commitment to support and sustain patient navigation; and 3) build capacity by mobilizing community support outside of the cancer center. CONCLUSIONS: This process-level article reflects the importance of collaboration and the usefulness of partnering with other cancer centers to share interdisciplinary insights while undergoing intervention development, implementation, and expansion. These collective insights may be useful to staff at other cancer centers that look to implement, enhance, or evaluate the effectiveness of their patient navigation interventions.

A Preliminary Study of Short-Term Sexual Function and Satisfaction Among Men Post-Myocardial Infarction.

Sexuality is an important component of holistic quality of life, and myocardial infarction (MI) negatively influences many aspects of sexuality, including sexual function. However, there is limited literature that examines sexuality beyond the most basic physical components. This pilot study aimed to describe the relationships between the physical, psychologic, and social domains of holistic sexuality at an early timepoint post-MI. Adult men post-MI were mailed self-report surveys at 2 weeks post discharge. Physical domains of sexuality were measured with the arousal, orgasm, erection, lubrication, and pain subscales of the Male Sexual Function Index (MSFI). The social domain utilized the sexual satisfaction subscale of the MSFI. The psychologic domain included the desire subscale of the MSFI and sexual fear (Multidimensional Sexuality Questionnaire). Spearman correlations were estimated to examine associations among the different measurement subscales. Twenty-four men post-MI were analyzed. Average scores on the MSFI were 9.2 (SD 7.7). Desire and satisfaction were the highest scoring subscales among men when compared with other subscales (i.e. erection, lubrication). There was minimal evidence supporting a relationship between sexual fear and function. Additional research is also needed with larger samples, and among women post-MI.

Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004.

PURPOSE: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities. METHODS: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test. RESULTS: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. CONCLUSION: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.

Sexual Function, Anxiety, Depression and Coping After Myocardial Infarction: An Exploratory Study.

Background: Myocardial infarction (MI) may decrease sexual function and satisfaction in men and can be influenced by anxiety, depression, and sexual fear. However, few studies have examined short-term changes in sexual function over time in a post-MI population. This study aimed to longitudinally describe changes in sexual function and satisfaction in a sample of men post-MI. Methods: Eighteen patients were recruited from a Midwestern hospital. Surveys were mailed two weeks and three months post discharge. Sexual function was measured with the Male Sexual Function Index. Other variables collected included sexual fear (Multidimensional Sexuality Questionnaire), anxiety and depressive symptoms (Patient-Reported Outcomes Measurement Information System Anxiety and Depression 4a), and use of coping strategies (Coping Strategy Indicator). Results: Sexual function scores increased in the entire sample from 8.9 (SD 7.3) at two weeks to 14.6 (SD 8.9) at three months (18.8% improvement, p=0.04). Men who were sexually active improved their scores by 27.3% (p=0.01), while those who were not sexually active decreased their scores by 2.3% (p=0.5). Depressive symptoms and anxiety scores were low and largely stable across timepoints, though there were some improvements among men who were sexually active compared to those who were not. Decreased utilization of avoidance coping strategies was reported in sexually active versus inactive men. Conclusion: While sexual function improved within a short-time period post discharge among sexually active men post-MI, further research is needed with a larger sample to understand these changes across a longer period. Additional research is also warranted to examine any potential influence of psychosocial predictors.

Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update.

PURPOSE: To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline. METHODS: An Expert Panel conducted a systematic review to identify new, potentially practice-changing data. RESULTS: Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations. RECOMMENDATIONS: Alpelisib in combination with endocrine therapy (ET) should be offered to postmenopausal patients, and to male patients, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, ABC, or MBC following prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Clinicians should use next-generation sequencing in tumor tissue or cell-free DNA in plasma to detect PIK3CA mutations. If no mutation is found in cell-free DNA, testing in tumor tissue, if available, should be used as this will detect a small number of additional patients with PIK3CA mutations. There are insufficient data at present to recommend routine testing for ESR1 mutations to guide therapy for HR-positive, HER2-negative MBC. For BRCA1 or BRCA2 mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered in the 1st-line through 3rd-line setting. A nonsteroidal aromatase inhibitor (AI) and a CDK4/6 inhibitor should be offered to postmenopausal women with treatment-naïve HR-positive MBC. Fulvestrant and a CDK4/6 inhibitor should be offered to patients with progressive disease during treatment with AIs (or who develop a recurrence within 1 year of adjuvant AI therapy) with or without one line of prior chemotherapy for metastatic disease, or as first-line therapy. Treatment should be limited to those without prior exposure to CDK4/6 inhibitors in the metastatic setting.Additional information can be found at www.asco.org/breast-cancer-guidelines.