Sexual dysfunction among early-onset colorectal cancer survivors: Sex-specific correlates of sexual health discussions between patients and providers.

PURPOSE: To examine the prevalence of female sexual dysfunction (FSD), male erectile dysfunction (ED), and the prevalence and correlates of sexual health discussions between early-onset CRC survivors and their health care providers. METHODS: An online, cross-sectional survey was administered in partnership with a national CRC advocacy organization. Respondents (n = 234; diagnosed < 50 years, 6-36 months from diagnosis/relapse) were colon (36.8%) and rectal (63.3%) cancer survivors (62.5% male). The Female Sexual Function Index (FSFI-6) was used to measure FSD, and the International Index of Erectile Function (IIEF-5) was used to measure ED. Survivors reported whether a doctor communicated with them about sexual issues during/after treatment. RESULTS: Among females (n = 87), 81.6% had FSD (mean FSFI-6 score = 14.3 [SD±6.1]). Among males (n = 145), 94.5% had ED (mean IIEF-5 score = 13.6 [SD±3.4]). Overall, 59.4% of males and 45.4% of females reported a sexual health discussion. Among the total sample, older age of diagnosis and relapse were significantly associated with reporting a discussion, while female sex was negatively associated with reporting a sexual health discussion. Among males, older age at diagnosis and relapse, and among females, older age of diagnosis, were significantly associated with reporting a sexual health discussion. CONCLUSION: The prevalence of FSD and ED were high (8 in 10 females reporting FSD, almost all males reporting ED), while reported rates of sexual health discussion were suboptimal (half reported discussion). Interventions to increase CRC provider awareness of patients at risk for not being counseled are needed to optimize long-term health outcomes.

Alliance A022104/NRG-GI010: The Janus Rectal Cancer Trial: a randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer.

BACKGROUND: Recent data have demonstrated that in locally advanced rectal cancer (LARC), a total neoadjuvant therapy (TNT) approach improves compliance with chemotherapy and increases rates of tumor response compared to neoadjuvant chemoradiation (CRT) alone. They further indicate that the optimal sequencing of TNT involves consolidation (rather than induction) chemotherapy to optimize complete response rates. Data, largely from retrospective studies, have also shown that patients with clinical complete response (cCR) after TNT may be managed safely with the watch and wait approach (WW) instead of preemptive total mesorectal resection (TME). However, the optimal consolidation chemotherapy regimen to achieve cCR has not been established, and a randomized clinical trial has not robustly evaluated cCR as a primary endpoint. Collaborating with a multidisciplinary oncology team and patient groups, we designed this NCI-sponsored study of chemotherapy intensification to address these issues and to drive up cCR rates, to provide opportunity for organ preservation, improve quality of life for patients and improve survival outcomes. METHODS: In this NCI-sponsored multi-group randomized, seamless phase II/III trial (1:1), up to 760 patients with LARC, T4N0, any T with node positive disease (any T, N +) or T3N0 requiring abdominoperineal resection or coloanal anastomosis and distal margin within 12 cm of anal verge will be enrolled. Stratification factors include tumor stage (T4 vs T1-3), nodal stage (N + vs N0) and distance from anal verge (0-4; 4-8; 8-12 cm). Patients will be randomized to receive neoadjuvant long-course chemoradiation (LCRT) followed by consolidation doublet (mFOLFOX6 or CAPOX) or triplet chemotherapy (mFOLFIRINOX) for 3-4 months. LCRT in both arms involves 4500 cGy in 25 fractions over 5 weeks + 900 cGy boost in 5 fractions with a fluoropyrimidine (capecitabine preferred). Patients will undergo assessment 8-12 (± 4) weeks post-TNT completion. The primary endpoint for the phase II portion will compare cCR between treatment arms. A total number of 312 evaluable patients (156 per arm) will provide statistical power of 90.5% to detect a 17% increase in cCR rate, at a one-sided alpha = 0.048. The primary endpoint for the phase III portion will compare disease-free survival (DFS) between treatment arms. A total of 285 DFS events will provide 85% power to detect an effect size of hazard ratio 0.70 at a one-sided alpha of 0.025, requiring enrollment of 760 patients (380 per arm). Secondary objectives include time-to event outcomes (overall survival, organ preservation time and time to distant metastasis) and adverse event rates. Biospecimens including archival tumor tissue, plasma and buffy coat, and serial rectal MRIs will be collected for exploratory correlative research. This study, activated in late 2022, is open across the NCTN and had accrued 330 patients as of May 2024. Study support: U10CA180821, U10CA180882, U24 CA196171; https://acknowledgments.alliancefound.org . DISCUSSION: Building on data from modern day rectal cancer trials and patient input from national advocacy groups, we have designed The Janus Rectal Cancer Trial studying chemotherapy intensification via a consolidation chemotherapy approach with the intent to enhance cCR and DFS rates, increase organ preservation rates, and improve quality of life for patients with rectal cancer. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT05610163; Support includes U10CA180868 (NRG) and U10CA180888 (SWOG).

Fertility Preservation Discussions Between Young Adult Rectal Cancer Survivors and Their Providers: Sex-Specific Prevalence and Correlates.

BACKGROUND: Young adults (YA) diagnosed with rectal cancer are disproportionately impacted by the gonadotoxic effects of treatment and potential subsequent infertility. OBJECTIVE: The purpose of this study was to characterize the prevalence of fertility preservation measures used, reasons why such measures were not used, and correlates of discussion between providers and YA rectal cancer survivors. DESIGN: An online, cross-sectional survey was administered on the Facebook page of a national colorectal cancer (CRC) advocacy organization. Eligible participants were rectal cancer survivors diagnosed before age 50, between 6 and 36 months from diagnosis or relapse, and based in the US. RESULTS: Participants were 148 rectal cancer survivors. Over half of the survivors reported that their doctor did not talk to them about potential therapy-related fertility complications. Only one-fifth of survivors banked sperm (males) or eggs/embryos (females) prior to their cancer therapy. Older age at diagnosis and greater quality of life were significantly associated with a higher likelihood of fertility discussions among males. Greater quality of life was significantly associated with a higher likelihood of fertility discussion among females. CONCLUSIONS: These findings indicate that the majority of YA rectal cancer survivors do not receive, or cannot recall, comprehensive cancer care, and help to identify patients with rectal cancer who may be at risk for inadequate fertility counseling. Clinicians should provide proper counseling to mitigate this late effect and to ensure optimal quality of life for YA rectal cancer survivors.

Advancing early onset colorectal cancer research: research advocacy, health disparities, and scientific imperatives.

Early onset colorectal cancer (EOCRC) emerged as the fourth foremost contributor to cancer-related mortality among both genders in the late 1990s. Presently, EOCRC (<50) ranks as the leading cause of cancer mortality in men and the second leading cause in women within the United States. Similar trends are now also evident globally, particularly in developed countries. Furthermore, there is strong evidence confirming that health disparities persist in the diagnosis and treatment of EOCRC, with signs indicating that these gaps may worsen in specific cases. These alarming trends highlight the critical need for research to inform evidence-based interventions to reduce the burden of EOCRC globally. Fight Colorectal Cancer (Fight CRC) is the leading patient advocacy group in the United States providing information on colon and rectal cancer research, prevention, treatment, and policy. It is the opinion of Fight CRC that an international, coordinated effort with the medical, research, scientific, advocacy, industry and funding community is needed to advance impactful research. Fight CRC, in partnership with José Perea, MD, PhD, of the Institute of Biomedical Research of Salamanca (IBSAL) in Spain, and partners, are working together to address this global phenomenon and are presenting a multi-faceted research approach to move the field forward.

#CRCandMe: results of a pre-post quasi-experimental study of a mass media campaign to increase early-onset colorectal cancer awareness in Utah and Wisconsin.

Overall colorectal cancer (CRC) incidence and mortality have been decreasing for several decades; however, since the early 1990s CRC incidence rates have nearly doubled among adults aged under 50 years. This study pilot-tested a community-based mass-media campaign aimed at improving knowledge and awareness of early-onset CRC in this population. The campaign (#CRCandMe) was deployed from June to September 2023 in Utah and Wisconsin. To evaluate its success (reach) and inform future campaigns, key performance indicators were defined (e.g., impressions, website traffic). To evaluate change in knowledge in the target population, the knowledge and awareness of participants recruited via consumer panels was assessed at baseline (n=235) and follow-up (n=161). The number of correct answers for each of seven knowledge items was calculated at baseline (pre-intervention) and follow-up (post-intervention). McNemar's test was employed to assess significant differences in the seven knowledge items between the two timepoints. The campaign delivered over 26.7 million impressions and nearly 43,000 clicks. A 15-second video ad received 221,985 plays, with 57,270 users watching to completion. Pre-survey results revealed that while 74% of participants were able to correctly identify CRC signs, only 18% could identify risk factors. Knowledge scores slightly improved from baseline to follow-up, with statistically significance for the question related to CRC signs (P=0.0004). This study demonstrated wide reach and may inform future larger-scale interventions and public health initiatives aimed at reducing CRC incidence and improving health outcomes for at-risk adults aged under 50 years.

Lights and shadows in the early-onset colorectal cancer management and research: An integrative perspective - Physician scientist with patient advocates.

Early-onset colorectal cancer (age under 50 years) (EOCRC) is an entity of undeniable importance, both because of its growing incidence, and the population it affects. Other current reviews emphasize the essential points regarding the clinical management and knowledge of its molecular bases. However, we intend to go one step further. With the increased significance of patient participation and disease experience in mind, we have integrated the voice of the patient to show the weaknesses and the needs, and next steps in the advancement of knowledge and management of EOCRC. This integrative review of the different perspectives, clinical, research and the patients themselves, can therefore be defined as an integrative needs assessment. Hence, this may be a first step in working towards an essential homogeneity of definitions and action.

Patient Care Satisfaction and Emergency Room Utilization among Young Adult Colorectal Cancer Survivors during the SARS-CoV-2 Pandemic: Lessons Learned.

Introduction: Survivors of colorectal cancer (CRC) are at risk for late effects of therapy and recurrence of cancer. With recurrence rates ranging between 30−40%, follow-up care is needed for both early detection and management of late effects. Cancer care delivery for CRC patients was significantly disrupted by the SARS-CoV-2 pandemic, with decreases of 40% in such services in the United States between April 2020 and 2019. Survivors were left with fewer options for care, potentially causing increases in emergency room (ER) utilization. Methods: This cross-sectional study examined the patterns of ER utilization during the SARS-CoV-2 pandemic among young adult CRC survivors and assessed the relationship between self-reported care satisfaction and ER use. Eligible participants were colon or rectal cancer survivors diagnosed between 18−39 years of age, 6−36 months from diagnosis/relapse, English speaking and residing in the United States. Multivariable logistic regression assessed the association between patient care satisfaction and ER utilization, adjusting for pandemic factors. Covariates were chosen by significance of p < 0.1 at the univariate level and perceived clinical significance. Results: The overall sample (N = 196) had mean age (SD) 32.1 (4.5); 59% were male. Tumor location was colon or rectal in 42% and 57%, respectively, and the majority (56%) were diagnosed with stage 2 disease; 42.6% reported relapsed disease, and 20% had an ostomy. Most survivors (72.5%) had between 1−4 visits to an ER in the last 12 months and were categorized as normal utilizers. Approximately 24.7% of the sample had greater than 4 visits to the ER in the last 12 months and were categorized as super-utilizers. CRC survivors that reported a delay in their follow-up care as a result of the pandemic were two times (OR: 2.05, 95% CI 0.99, 4.24) more likely to be super-utilizers of the ER. Higher self-reported satisfaction with care was associated with a 13.7% lower likelihood of being a super-utilizer (OR: 0.86, 95%CI: −0.68, 1.09). Conclusions: This study found strong associations between delays in care, self-reported care satisfaction, and being a super-utilizer of the ER during the pandemic among young adult CRC survivors off treatment. Increasing patient satisfaction and minimizing care interruptions amongst this vulnerable population may aid in mitigating over-utilization in the ER during an ongoing pandemic.

Impacts of the SARS-CoV-2 Pandemic on Young Adult Colorectal Cancer Survivors.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has disrupted health care globally with dramatic impacts on cancer care delivery in addition to adverse economic and psychological effects. This study examined impacts of the SARS-CoV-2 pandemic on young adult colorectal cancer (CRC) survivors diagnosed age 18-39 years. Nearly 40% reported delays in cancer-related care, loss of income, and poorer mental health during the pandemic. Impacts were greater for survivors aged 20-29 years, with nearly 60% reporting cancer care delays and 53% experiencing income loss. Such impacts may result in detrimental downstream outcomes for young CRC survivors, requiring specific support, resources, and continued monitoring.

Early-Onset Colorectal Cancer Survival Differences and Potential Geographic Determinants Among Men and Women in Utah.

By 2030, early-onset colorectal cancer (EOCRC) is expected to become the leading cancer-related cause of death for people age 20 to 49. To improve understanding of this phenomenon, we analyzed the geographic determinants of EOCRC in Utah by examining county-level incidence and mortality. We linked data from the Utah Population Database to the Utah Cancer Registry to identify residents (age 18-49) diagnosed with EOCRC between 2000 and 2020, and we used spatial empirical Bayes smoothing to determine county-level hotspots. We identified 1,867 EOCRC diagnoses (52.7% in male patients, 69.2% in non-Hispanic White patients). Ten counties (34%) were classified as hotspots, with high EOCRC incidence or mortality. Hotspot status was unrelated to incidence rates, but non-Hispanic ethnic-minority men (incidence rate ratio, 1.49; 95% CI, 1.15-1.91), Hispanic White men and women (incidence rate ratio, 2.24; 95% CI, 2.00-2.51), and Hispanic ethnic-minority men and women (incidence rate ratio, 4.59; 95% CI, 3.50-5.91) were more likely to be diagnosed with EOCRC. After adjustment for income and obesity, adults living in hotspots had a 31% higher hazard for death (HR, 1.31; 95% CI, 1.02-1.69). Survival was poorest for adults with a late-stage diagnosis living in hotspots (chi square (1) = 4.0; p = .045). Adults who were married or who had a life partner had a lower hazard for death than single adults (HR, 0.73; 95% CI, 0.58-0.92). The risk for EOCRC is elevated in 34% of Utah counties, warranting future research and interventions aimed at increasing screening and survival in the population age 18 to 49.

Time from Diagnosis and Correlates of Health-Related Quality of Life among Young Adult Colorectal Cancer Survivors.

The incidence of colorectal cancer (CRC) is rising among young adults. Health-related quality of life (HRQoL) in survivorship is not well-described in this population. We assessed HRQoL among young adult CRC survivors diagnosed from age 18-39 (AYAs) to examine differences by time from diagnosis, and to identify key correlates. A cross-sectional online survey was administered in collaboration with a national patient advocacy organization. The Functional Assessment of Cancer Therapy (FACT-C) was used to measure HRQoL, which assesses HRQoL globally and across 4 domains: emotional, physical, social, and functional. T-tests were conducted to compare HRQoL between survivors who were 6-18 months versus 19-36 months from diagnosis or relapse and multiple linear regression was conducted to identify correlates. The sample (n = 196) had a mean age of 32.2(SD ± 4.5); 116 (59.9%) were male; and the self-reported tumor location was colon (39.3%) or rectal (60.7%). The majority (56.4%) were diagnosed with stage 2 disease; 96.9% were non-metastatic. The mean global HRQoL score was 67.7 out of a possible score of 136. Across domains, mean scores were low. Emotional and physical well-being were significantly higher among survivors who were 19-36 months from diagnosis/relapse compared to those 6-18 months from diagnosis/relapse. Longer time from diagnosis and older current age were associated with higher HRQoL, while more intensive treatment and higher clinical disease stage were negatively associated, particularly in the emotional and physical domains. Overall, HRQoL was low in this population, and further research is needed to inform age-appropriate interventions to improve HRQoL for AYA CRC survivors.

Protocol for #iBeatCRC: a community-based intervention to increase early-onset colorectal cancer awareness using a sequential explanatory mixed-methods approach.

INTRODUCTION: Th last two decades have seen a twofold increase in colorectal cancer (CRC) incidence among individuals under the recommended screening age of 50 years. Although the origin of this early-onset CRC (EOCRC) spike remains unknown, prior studies have reported that EOCRC harbours a distinct molecular and clinical phenotype in younger individuals. The sharp increase in EOCRC incidence rates may be attributable to a complex interplay of factors, including race; lifestyle; and ecological, sociodemographic and geographical factors. However, more research that address psychosocial experiences and accounts for lifestyle-related behaviours before, during and after an EOCRC diagnosis are warranted. This study aims to develop and pilot test a theory-driven, community-based intervention to increase awareness of EOCRC, reduce its associated risk factors and improve early detection among adults aged 18-49 years. METHODS AND ANALYSIS: Guided by the Behaviour Change Wheel, we will use a multistage mixed-methods study design. We will pilot a sequential mixed-methods intervention study as follows: (1) First, we will analyse linked quantitative data from the Utah Cancer Registry and National Cancer Institute Surveillance, Epidemiology and End Results registry, linked to state-wide demographic and vital records in the Utah Population Database to identify EOCRC hotspots in Utah by examining the EOCRC incidence and survival variance explained by personal and county-level factors. (2) Next, we will conduct one-on-one interviews with 20 EOCRC survivors residing in EOCRC hotspots to ascertain psychosocial and lifestyle challenges that accompany an EOCRC diagnosis. (3) Finally, we will consider existing evidence-based approaches, our integrated results (quantitative +qualitative) and community action board input to design a community-based intervention to increase EOCRC awareness that can feasibly be delivered by means of outdoor mass media, and via social media. We will pilot the multicomponent media campaign with a quasiexperimental design among 17 EOCRC hotspot residents and 17 EOCRC 'coldspot' residents. ETHICS AND DISSEMINATION: Ethics approval was obtained from the University of Utah Institutional Review Board (IRB_00138357). Signed informed consent will be obtained from all participants prior to any data collection. Study results will be disseminated through CRC community blogs, targeted infographics, conference presentations at national and international professional conferences and publications in peer-reviewed journals. Final intervention-specific data will be available on reasonable request from the corresponding author. TRIAL REGISTRATION NUMBER: NCT04715074.