ABSTRACT
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).
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Fluorouracil , Neoadjuvant Therapy , Rectal Neoplasms , Humans , Rectal Neoplasms/therapy , Rectal Neoplasms/pathology , Rectal Neoplasms/mortality , Rectal Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Neoadjuvant Therapy/methods , Fluorouracil/administration & dosage , Fluorouracil/therapeutic use , Male , Female , Disease-Free Survival , Leucovorin/administration & dosage , Leucovorin/therapeutic use , Oxaliplatin/administration & dosage , Oxaliplatin/therapeutic use , Capecitabine/administration & dosage , Capecitabine/therapeutic use , Irinotecan/administration & dosage , Irinotecan/therapeutic use , Middle Aged , Treatment Outcome , Quality of Life , Neoplasm Staging , Organoplatinum CompoundsABSTRACT
The COVID-19 pandemic heightened the psychosocial impact of a cancer diagnosis as patients face concerns about the risk of infection and serious disease and uncertainties about the impact on their treatment. We conducted an online survey (n = 317) and focus groups (n = 19) with patients to examine their experiences with cancer care during the pandemic. Most survey respondents (68%) reported one or more disruptions or delays in care, including appointments switched to telehealth (49%). Patients perceived both benefits (e.g., convenience) and drawbacks (e.g., more impersonal) to telehealth. For many patients, COVID-19-related restrictions on bringing family members to support them during appointments was a major concern and left them feeling alone and vulnerable during treatment. Patients' self-reported coping during the pandemic was positively associated with age, education, and income (P < .05 for each) and better communication with their doctors during telehealth sessions (P < .001). Study findings highlight the importance of patient-centered care and communication to help patients cope with the challenges of the pandemic. Further research is needed to develop guidelines for use of telehealth as part of patient-centered cancer care.
ABSTRACT
OBJECTIVE: Patients undergoing cancer treatment during the COVID-19 pandemic have experienced stress and uncertainty with respect to disruptions in cancer care and COVID-19 related risks. We examined whether clinicians' responsiveness to patients' uncertainty and difficult emotions were associated with better health and well-being. METHODS: Patients were recruited from cancer support communities and a market research firm. Respondents assessed clinicians communication that addressed uncertainty and difficult emotions. Health status measures included mental and physical health, coping during the pandemic, and psychological distress. RESULTS: 317 respondents participated in the study. Patients' perceptions of their clinicians responsiveness to patient uncertainty and negative emotions were associated with better mental health, physical health, coping, and less psychological distress (all p-values <0.001). Respondents with greater self-efficacy and social support also reported better health. CONCLUSION: Even when controlling for patients' personal and health-related characteristics, clinicians' communication addressing patients' uncertainty and difficult emotions predicted better health, better coping, and less psychological distress. Access to social support and self-efficacy also were associated with better health status. PRACTICE IMPLICATIONS: Clinicians' communication focused on helping with uncertainty and difficult emotions is important to cancer patients, especially during the pandemic. Clinicians should also direct patients to resources for social support and patient empowerment.
Subject(s)
COVID-19 , Neoplasms , Physicians , COVID-19/epidemiology , Emotions , Humans , Neoplasms/psychology , Neoplasms/therapy , Pandemics , Physicians/psychology , UncertaintyABSTRACT
OPINION STATEMENT: Research advocacy is an evolving concept and should be tailored for the colorectal cancer research community. Research advocacy training and evaluation must be designed for the patient community with their insight included at each step of engagement, training, and implementation. Patient advocates bring a great deal of expertise to the research review process, but it is important to ensure that their insight is appropriately placed, and they bring an appropriate orientation to the research process as the most informed patient. This can be accomplished in part by providing advocates with the proper training, employing universal core competencies, and applying principles of adult learning. Additionally, the research community, advocacy organizations, and industry partners must understand the need to diversify the voices that are being leveraged to guide research, recognizing the importance of adequate mental health tools and compensation commensurate with their experience. As a community, it is necessary that we create and implement training programs, as well as evaluate and measure their impact to continually improve and tailor the delivery of this specific education. Research advocacy has become a necessity to the field, and when implemented effectively, research advocates can have a significant impact on the delivery of health care research, improving health outcomes for all those affected by colorectal cancer.
Subject(s)
Colorectal Neoplasms , Adult , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/therapy , HumansABSTRACT
PURPOSE: The COVID-19 pandemic created significant disruptions in cancer care, much of which was transitioned to telehealth. Because telehealth alters the way clinicians and patients interact with one another, this investigation examined patients' perceptions of their communication with clinicians during the pandemic. METHOD: Patients were recruited from the Cancer Support Community, Fight Colorectal Cancer, and a market research firm to participate in an online survey. In addition to demographic and health-related information, respondents completed measures of patient-centered communication and evaluated how their communication in telehealth sessions compared with in-person visits. RESULTS: From October to December 2020, 227 respondents (65.6% female, 64.6% Non-Hispanic White, 33.5% had 6 or more telehealth sessions, 55% were 50 or older) reported having some of their cancer care provided via telehealth. Respondents who were of racial/ethnic minorities, male, had more telehealth sessions, or had poorer mental health reported less patient-centered communication with clinicians. Most patients thought communication in telehealth sessions was "about the same" as in-person visits with respect to good communication (59%). However, patients thinking communication in telehealth sessions was "better" than in-person visits were more likely to be Hispanic (49%), Non-Hispanic Black (41%), under 50 years of age (32%), male (40%), and had more telehealth sessions (34%). CONCLUSION: Respondents reporting less patient-centered communication during the pandemic-e.g., persons of racial/ethnic minorities and males-were also more likely to evaluate communication in telehealth sessions as better than in-person visits. Further research is needed to understand reasons underlying this finding. Cancer care clinicians should take into account patient preferences regarding telehealth care, which may be particularly important for racial and ethnic minority patients.
Subject(s)
COVID-19 , Neoplasms , Telemedicine , Communication , Ethnicity , Female , Humans , Male , Minority Groups , Neoplasms/therapy , Pandemics , Referral and Consultation , Telemedicine/methodsABSTRACT
BACKGROUND: Colorectal cancer (CRC) is the third most common cancer among men and women in the United States. Patients and survivors experience a range of challenges, including anxiety, financial issues, long-term adverse effects, and more. The intent of this project was to assess the needs of the CRC community directly from survivors and their caregivers and to lay a foundation for ongoing support. METHODS: Twelve nominal group technique sessions were facilitated. Participants were randomized and presented with the following questions: "What information do you wish you had at the time of diagnosis?" and "What information do you need now as a survivor?" After the nominal group technique process, each statement's score was divided by the number of people in the session, providing the average to identify the top-ranked statements. Themes and subthemes were applied to statements. Results were compared between coders. RESULTS: There was a total of 79 participants, 49 of whom self-identified as a patient with or survivor of cancer. Patient/survivor demographics were as follows: stage IV disease (n=20), stage III disease (n=22), stage II disease (n=5), stage I disease (n=2), caregiver/family member (n=30), male (n=16), female (n=63), White (n=50), Native Hawaiian/Pacific Islander (n=1), Hispanic/Latino (n=13), Black/African American (n=11), Asian (n=1), and more than one race/ethnicity (n=3). The most frequent themes among responses to the first question were communication and coordination with care team and access to CRC resources. The most frequent themes among responses to the second question were psychosocial support and family/caregiver support. Frequent themes among responses across both questions were understanding treatment options and adverse effects. CONCLUSIONS: These findings highlight gaps in support for individuals affected by CRC, and lay a foundation for ongoing assistance. Future studies exploring differences based on disease stage, race/ethnicity, age, gender identity, geographic location, and tumor location are needed to further tailor support for those experiencing CRC. Themes identified in this project require a multidisciplinary approach to ensure that the unmet needs of survivors are addressed.