SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Intervention in Survivors of Rectal Cancer.

BACKGROUND: Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. METHODS: Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N = 47) or the Healthy Living Education attention control group (N = 46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26 weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. RESULTS: Most participants were White and college educated, with a mean age of 55.2 years and median time since surgery of 13.1 months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p = .01) and the frequency subscale of the bowel function index (p = .03). The AIMS-RC group reported significantly higher acceptability of the study. CONCLUSIONS: SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Recruitment of informal caregivers into community oncology research studies: results from the 2022 Landscape Assessment.

Understanding the experiences of community oncology practices in recruiting informal (unpaid/family) caregivers into research studies can inform strategies to improve caregiver enrollment. We used data from the 2022 National Cancer Institute Community Oncology Research Program (NCORP) Landscape Assessment to describe the experience of recruiting informal caregivers for research studies in community oncology practices. Among 258 practice groups, only one-third (30%, 78/258) reported prior experience recruiting informal caregivers for research studies. In multivariable logistic analyses, having a greater number of oncology providers (increase per 10 providers, adjusted odds ratio [AOR] 1.16, 95% CI 1.03-1.31) and having advanced practice providers (APPs) involved in research (AOR 2.17, 95% CI 1.05-4.48) were significantly associated with prior experience recruiting caregivers. In conclusion, many community oncology practices lack caregiver recruitment experience and may benefit from education, integration of APPs/caregiver stakeholders in research infrastructure, and/or other strategies to improve caregiver recruitment.

Baseline characteristics and recruitment for SWOG S1820: altering intake, managing bowel symptoms in survivors of rectal cancer (AIMS-RC).

PURPOSE: Many survivors of rectal cancer experience persistent bowel dysfunction. There are few evidence-based symptom management interventions to improve bowel control. The purpose of this study is to describe recruitment and pre-randomization baseline sociodemographic, health status, and clinical characteristics for SWOG S1820, a trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention. METHODS: SWOG S1820 aimed to determine the preliminary efficacy, feasibility, and acceptability of AIMS-RC, a symptom management intervention for bowel health, comparing intervention to attention control. Survivors with a history of cancers of the rectosigmoid colon or rectum, within 6-24 months of primary treatment completion, with a post-surgical permanent ostomy or anastomosis, and over 18 years of age were enrolled. Outcomes included total bowel function, low anterior resection syndrome, quality of life, motivation for managing bowel health, self-efficacy for managing symptoms, positive and negative affect, and study feasibility and acceptability. RESULTS: The trial completed accrual over a 29-month period and enrolled 117 participants from 34 institutions across 17 states and one US Pacific territory. At baseline, most enrolled participants reported self-imposed diet adjustments after surgery, persistent dietary intolerances, and bowel discomfort post-treatment, with high levels of constipation and diarrhea (grades 1-4). CONCLUSIONS: SWOG S1820 was able to recruit, in a timely manner, a study cohort that is demographically representative of US survivors of rectal cancer. Baseline characteristics illustrate the connection between diet/eating and bowel symptoms post-treatment, with many participants reporting diet adjustments and persistent inability to be comfortable with dietary intake. GOV REGISTRATION DATE: 12/19/2019. GOV IDENTIFIER: NCT#04205955.

Cancer care coordination in rural Hawaii: a focus group study.

BACKGROUND: Rural populations consistently experience a disproportionate burden of cancer, including higher incidence and mortality rates, compared to the urban populations. Factors that are thought to contribute to these disparities include limited or lack of access to care and challenges with care coordination (CC). In Hawaii, many patients residing in rural areas experience unique challenges with CC as they require inter-island travel for their cancer treatment. In this focus group study, we explored the specific challenges and positive experiences that impact the CC in rural Hawaii cancer patients. METHODS: We conducted two semi-structured focus group interviews with cancer patients receiving active treatment for any type of cancer (n = 8). The participants were recruited from the rural areas of Hawaii, specifically the Hawaii county and Kauai. Rural was defined using the Rural-Urban Commuting Area Codes (RUCA; rural ≥ 4). The focus group discussions were facilitated using open-ended questions to explore patients' experiences with CC. RESULTS: Content analysis revealed that 47% of the discussions were related to CC-related challenges, including access to care (27.3%), insurance (9.1%), inter-island travel (6.1%), and medical literacy (4.5%). Other major themes from the discussions focused on facilitators of CC (30.3%), including the use of electronic patient portal (12.1%), team-based approach (9.1%), family caregiver support (4.5%), and local clinic staff (4.5%). CONCLUSION: Our findings indicate that there are notable challenges in rural patients' experiences regarding their cancer care coordination. Specific factors such as the lack of oncologist and oncology services, fragmented system, and the lack of local general medical providers contribute to problems with access to care. However, there are also positive factors found through the help of facilitators of CC, notability the use of electronic patient portal, team-based approach, family caregiver support, and local clinic staff. These findings highlight potential targets of interventions to improve cancer care delivery for rural patients. TRIAL REGISTRATION: Not required.

Use of web-based decision support to improve informed choice for chemoprevention: a qualitative analysis of pre-implementation interviews (SWOG S1904).

BACKGROUND: Women with high-risk breast lesions, such as atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), have a 4- to tenfold increased risk of breast cancer compared to women with non-proliferative breast disease. Despite high-quality data supporting chemoprevention, uptake remains low. Interventions are needed to break down barriers. METHODS: The parent trial, MiCHOICE, is a cluster randomized controlled trial evaluating the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. For this pre-implementation analysis, 25 providers participated in semi-structured interviews prior to accessing decision support tools. Interviews sought to understand attitudes/beliefs and barriers/facilitators to chemoprevention. RESULTS: Interviews with 25 providers (18 physicians and 7 advanced practice providers) were included. Providers were predominantly female (84%), white (72%), and non-Hispanic (88%). Nearly all providers (96%) had prescribed chemoprevention for eligible patients. Three themes emerged in qualitative analysis. The first theme describes providers' confidence in chemoprevention and the utility of decision support tools. The second theme elucidates barriers to chemoprevention, including time constraints, risk communication and perceptions of patients' fear of side effects and anxiety. The third theme is the need for early implementation of decision support tools. CONCLUSIONS: This qualitative study suggests that providers were interested in the early inclusion of decision aids (DA) in their chemoprevention discussion workflow. The DAs may help overcome certain barriers which were elucidated in these interviews, including patient level concerns about side effects, clinic time constraints and difficulty communicating risk. A multi-faceted intervention with a DA as one active component may be needed. TRIAL REGISTRATION: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT04496739.

Telehealth amid the COVID-19 pandemic: perception among Asian, Native Hawaiian and Pacific Islander cancer patients.

Aim: To assess the perception of telehealth visits among a multiracial cancer population during the coronavirus disease 2019 pandemic. Methods: This cross-sectional study was conducted at outpatient cancer clinics in Hawaii between March and August 2020. Patients were invited to participate in the survey either by phone or email. Results: Of the 212 survey respondents, 61.3% were Asian, 23.6% were White and 15.1% were Native Hawaiians or Pacific Islanders. Asians, Native Hawaiians and Pacific Islanders were less likely to desire future telehealth visits compared with Whites. Predictors with regard to preferring future telehealth visits included lower income and hematopoietic cancers. Conclusion: The authors found racial differences in preference for telehealth. Future studies aimed at overcoming these racial disparities are needed to provide equitable oncology care.

Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program.

PURPOSE: Oncology advanced practice providers (APPs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists, contribute significantly to quality cancer care. Understanding the research-related roles of APPs in the National Cancer Institute's (NCI) Community Oncology Research Program (NCORP) could lead to enhanced protocol development, trial conduct, and accrual. METHODS: The 2022 NCORP Landscape Assessment Survey asked two questions about the utilization and roles of APPs in the NCORP. RESULTS: A total of 271 practice groups completed the 2022 survey, with a response rate of 90%. Of the 259 nonpediatric exclusive practice groups analyzed in this study, 92% used APPs for clinical care activities and 73% used APPs for research activities. APPs most often provided clinical care for patients enrolled in trials (97%), followed by assistance with coordination (65%), presenting/explaining clinical trials (59%), screening patients (49%), ordering investigational drugs (37%), and consenting participants (24%). Some groups reported APPs as an enrolling investigator (18%) and/or participating in institutional oversight/selection of trials (15%). Only 5% of NCORP sites reported APPs as a site primary investigator for trials, and very few (3%) reported APPs participating in protocol development. CONCLUSION: Practice groups report involving APPs in clinical research within the NCORP network; however, opportunities for growth exists. As team-based care has enhanced clinical practice in oncology, this same approach can be used to enhance successful research. Suggested strategies include supporting APP research-related time, recognition, and education. The findings of this survey and subsequent recommendations may be applied to all adult oncology practices that participate in clinical research.

Information Technology and Telemedicine Services in Community Oncology Practices.

PURPOSE: We described information technology support and use of telemedicine for cancer care and research purposes at community oncology practices within the National Cancer Institute Community Oncology Research Program (NCORP). METHODS: We used data from the NCORP 2017 and 2022 Landscape Assessments. Separate logistic regression models were used to assess factors associated with the use of telemedicine for delivery of cancer care in 2017 and for research purposes in 2022 (cancer care delivery not assessed in 2022). RESULTS: Information was available from 210 and 259 practice groups excluding pediatric-only groups in 2017 and 2022, respectively. In 2017, 30% of practice groups used telemedicine for delivery of cancer care; half of these (15% overall) could use telemedicine for research purposes. In 2022, telemedicine was used for research purposes in 73% of practice groups. In multivariable models, self-identifying as a safety-net hospital was associated with a lower odd of telemedicine use for delivery of cancer care (adjusted odds ratio [AOR], 0.39; 95% CI, 0.17 to 0.93), whereas affiliation with a designated critical access hospital was associated with a higher odd of telemedicine use for delivery of cancer care (AOR, 2.29; 95% CI, 1.10 to 4.76). Having a general survivorship clinic (AOR, 1.92; 95% CI, 1.04 to 3.54) and number of oncology providers (increase per 10 providers; AOR, 1.32; 95% CI, 1.05 to 1.65) were associated with telemedicine use for research purposes. CONCLUSION: Almost one third of NCORP practice groups used telemedicine for cancer care delivery in 2017. In 2022, there is high capacity among NCORP practices (almost three-quarters) to use telemedicine for research purposes, especially among practices with a general survivorship clinic and a greater provider number.

Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials.

The workshop "Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities" included a Patient Stakeholder Workgroup that explored the needs and concerns of older adults with cancer regarding clinical trials. To accomplish this, the workgroup conducted patient focus groups in which participants were interviewed, recorded conversations were analyzed and coded, and salient themes were identified. The focus groups identified general barriers to accrual such as complex consent forms, general communication, restrictive eligibility, nonreferrals, patient costs, cultural insensitivity, limited accessibility in community settings, and transportation issues. They also identified the influence of knowledgeable information presenters, improved care, family or caregiver support, and the desire to help others as drivers or reasons to participate in clinical trials. The workshop concluded that multi-level interventions could be used to increase the accrual of older adults to National Cancer Institute clinical trials as well as others.

Enrolling Older Adults Onto National Cancer Institute-Funded Clinical Trials in Community Oncology Clinics: Barriers and Solutions.

In April 2021, the National Cancer Institute (NCI) Division of Cancer Prevention collaborated with the NCI Division of Cancer Treatment and Diagnosis to produce a virtual workshop that developed recommendations for enhancing NCI-sponsored clinical trial accrual of older adults. Prior to the workshop, a multidisciplinary group of stakeholders (eg, community oncologists, advanced practice practitioners, clinic and research staff, and patient advocates) gathered information related to accrual of older adults to clinical trials from the literature. Subsequently, a survey was conducted to detail NCI Community Oncology Research Program members' perspective on accrual barriers for this population; 305 individuals responded to the survey. Barriers to clinical trial accruals included comorbidity-attributed trial ineligibility, transportation and time issues, concern that the proposed regimen is too toxic for older adults, patient or family caregiver declined participation, and lack of trials relevant to older patients. Identified solutions included broadening clinical trial inclusion criteria, increasing the number of clinical trials specifically designed for older adults, simplifying consent forms, improving recruitment materials for older adults and their families, and facilitating transportation vouchers. At the workshop, participants, including stakeholders, used prior literature and survey results to develop recommendations, including interventions to address clinician bias, implement geriatric assessment, and promote clinician and staff engagement as mechanisms to improve accrual of older adults to clinical trials.

Racial Disparities in Patient-Provider Communication During Telehealth Visits Versus Face-to-face Visits Among Asian and Native Hawaiian and Other Pacific Islander Patients With Cancer: Cross-sectional Analysis.

BACKGROUND: Telehealth visits increase patients' access to care and are often rated as "just as good" as face-to-face visits by oncology patients. Telehealth visits have become increasingly more common in the care of patients with cancer since the advent of the COVID-19 pandemic. Asians and Pacific Islanders are two of the fastest growing racial groups in the United States, but there are few studies assessing patient satisfaction with telemedicine among these two racial groups. OBJECTIVE: Our objective was to compare satisfaction with communication during telehealth visits versus face-to-face visits among oncology patients, with a specific focus on Asian patients and Native Hawaiian and other Pacific Islander (NHOPI) patients. METHODS: We surveyed a racially diverse group of patients who were treated at community cancer centers in Hawaii and had recently experienced a face-to-face visit or telehealth visit. Questions for assessing satisfaction with patient-physician communication were adapted from a previously published study of cancer survivors. Variables that impact communication, including age, sex, household income, education level, and cancer type and stage, were captured. Multivariable logistic models for patient satisfaction were created, with adjustments for sociodemographic factors. RESULTS: Participants who attended a face-to-face visit reported higher levels of satisfaction in all communication measures than those reported by participants who underwent a telehealth encounter. The univariate analysis revealed lower levels of satisfaction during telehealth visits among Asian participants and NHOPI participants compared to those among White participants for all measures of communication (eg, when asked to what degree "[y]our physician listened carefully to you"). Asian patients and NHOPI patients were significantly less likely than White patients to strongly agree with the statement (P<.004 and P<.007, respectively). Racial differences in satisfaction with communication persisted in the multivariate analysis even after adjusting for sociodemographic factors. There were no significant racial differences in communication during face-to-face visits. CONCLUSIONS: Asian patients and NHOPI patients were significantly less content with patient-physician communication during telehealth visits when compared to White patients. This difference among racial groups was not seen in face-to-face visits. The observation that telehealth increases racial disparities in health care satisfaction should prompt further exploration.

Role of Oncology Advanced Practitioners to Enhance Clinical Research.

Background: Oncology advanced practitioners (APs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists contribute significantly to quality cancer care. Advanced practitioners enhance value across the spectrum of cancer care. Research is an underdeveloped component of quality care, as well as an underdeveloped component of AP practice. Understanding research-related attitudes and roles of APs could lead to enhanced clinical trial accrual, conduct, and protocol development. Methods: A nationwide survey addressing attitudes, beliefs, and roles of APs regarding clinical research was distributed by the Association of Community Cancer Centers (ACCC) and Harborside in early 2020. Results: 408 oncology APs completed the survey. Thirty-five percent practice in an academic setting and 62% in the community. Nearly all respondents believe clinical trials are important to improve care, and over 90% report clinical trials are available at their practice. About 80% report being comfortable discussing the topic of clinical trials with patients and are involved in the care of trial participants. Sixty percent are comfortable discussing available trials, and 38% routinely explore available trials with patients. While 70% report approaching eligible patients about trials, only 20% report doing so "a great deal" or "a lot." Ninety percent report that APs should play a role in clinical research, and 73% want to be more involved. Barriers identified to greater AP clinical trial involvement include lack of time, inadequate awareness of trial specifics, and a lack of a formal role in protocol development and leadership. Conclusions: Advanced practitioners are engaged and interested in clinical trials and believe clinical research is important to improve cancer care. Multidisciplinary team integration, trials-related education, and policy change are needed to employ APs to their full potential within cancer clinical trials.

Recruiting Cancer Survivors to a Mobile Mindfulness Intervention in the United States: Exploring Online and Face-to-Face Recruitment Strategies.

Cancer survivorship research faces several recruitment challenges, such as accrual of a representative sample, as well as participant retention. Our study explores patterns in recruited demographics, patient-reported outcomes (PROs), and retention rates for a randomized controlled trial (RCT) utilizing a mobile mindfulness intervention for the well-being of cancer survivors. In total, 123 participants were recruited using traditional and online strategies. Using the chi-square test of independence, recruitment type was compared with demographic and clinical variables, PROs, and retention at Time 2 and Time 3. Online recruitment resulted in almost double the yield compared to traditional recruitment. Online-recruited participants were more often younger, from the continental U.S., Caucasian, diagnosed and treated less recently, at a later stage of diagnosis, diagnosed with blood cancer, without high blood pressure, and with less reported pain. The recruitment method was not significantly associated with retention. Online recruitment may capture a larger, broader survivor sample, but, similar to traditional recruitment, may also lead to selection biases depending on where efforts are focused. Future research should assess the reasons underlying the higher yield and retention rates of online recruitment and should evaluate how to apply a mix of traditional and online recruitment strategies to efficiently accrue samples that are representative of the survivor population.

SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial).

OBJECTIVE: To describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC). DESIGN: SWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. SETTING: Affiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). PARTICIPANTS: Survivors of rectal cancer who are between 6 and 24 months after treatment completion. INTERVENTION: AIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. MAIN OUTCOME MEASURES: Bowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. ANALYSIS: Thirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.

Understanding Attitudes and Roles of Oncology Advanced Practitioners in the Setting of Cancer Clinical Trials: A Pilot Study.

PURPOSE: Oncology advanced practitioners (APs), including nurse practitioners, physician assistants, clinical nurse specialists, and pharmacists, are skilled health-care providers who contribute significantly to quality cancer care. However, little is known about how APs function within the clinical trials arena. With low rates of clinical trial enrollment among the adult oncology patient population, APs could play an important role in improving clinical trial enrollment. METHODS: A descriptive cross-sectional study was conducted based on a 57-item survey of oncology APs' attitudes, beliefs, and roles in relation to cancer clinical trials. RESULTS: To assess validity and internal consistency of the survey, a pilot data collection was completed on 14 respondents from Hawaii. The survey's internal consistency across the subscales was moderate to very high, with Cronbach's alpha ranging between 0.55 and 0.86. The majority of oncology APs were interested in being more involved in the clinical trials process, and many are registered as investigators through the National Cancer Institute (NCI). However, few respondents reported being involved in recruitment, consenting, protocol development, or being actively involved with a research base. CONCLUSIONS: This survey was found to be a valid tool to measure APs' attitudes and roles in regards to clinical trials. This survey is just the beginning of data collection in regards to clinical trials among this group of health-care professionals. RECOMMENDATIONS: To gain further insight into oncology APs and their roles in clinical trials, it is recommended that this survey be implemented on a national level as a first step in moving this issue forward.