Cancer and Treatment Distress (CTXD) and Confidence in Survivorship Information (CSI) Trends in Older (≥60 Years) Allogeneic Hematopoietic Cell Transplantation (AlloHCT) Survivors

Background: AlloHCT survivors generally report higher rates of cancer- and treatment-related distress compared to the general population, although data on cancer and treatment Distress (CTXD) and Confidence in Survivorship Information (CSI) in older alloHCT recipients are limited. We have reported that older HCT survivors have generally low levels of distress and intermediate-high level of CSI (Al-Mansour et al, abstract submitted to ASH 2021 meeting). In this study, we describe specific distress and CSI concerns reported by older alloHCT survivors and their association with other patient-reported outcomes and transplant-related factors. Methods: This cross-sectional retrospective secondary analysis used baseline data from two randomized controlled trials of survivorship interventions in alloHCT recipients enrolled in 18 US transplant centers (combined dataset from survivorship care plan trial [NCT00799461] and internet based self-management intervention trial [NCT01602211]). A total of 181 enrolled patients transplanted from 2003-2014 were ≥60 years of age at alloHCT and were alive and disease-free at ≥1-year post-transplant. All donor and graft types were included in this analysis. Distress was measured by CTXD scale, in which higher values indicate higher levels of distress. Survivorship confidence was based on the CSI questionnaire, in which higher values indicate greater confidence. Health-related quality of life (HQOL) was assessed with the SF-12, with high scores indicating better physical function (PCS) and mental function (MCS). Clinical and sociodemographic variables were summarized in descriptive statistics. Non-parametric test (Wilcoxon rank sum test / Kruskal-Wallis test) was conducted for comparing two or three groups for CTXD/CSI. Spearman correlation and univariate linear regression model were used to evaluate associations between CTXD/CSI and PCS/MCS. Bonferroni correlation was used to adjust for multiple pairwise comparisons within age group at transplant. Results: The median age of this older sample at alloHCT was 64 (range 60-81), with the largest proportions non-Hispanic (96%), White (97%), and males (57%). The majority received peripheral blood grafts (88%) from an unrelated donor (65%) for their first (96%) transplant. At the time of the survey, survivors were at a median of 3 years (range 1-9) from alloHCT. Mean CTXD overall score was 0.85 (standard deviation [SD] 0.44). Among CTXD items, highest distress was reported for "low energy" (mean 1.42, SD 0.97) followed by "feeling tired and worn out" (mean 1.32, SD 0.93) and "not being able to do what I used to do" (mean 1.28, SD 0.98), while the lowest distress was reported for "communication with medical people"(mean 0.32, SD 0.66) and "getting information when I need it" (mean 0.39, SD 0.70; Figure 1). Similarly, mean CSI overall score was 1.39 (SD 0.44) in this Among CSI items, information on "disease treated" (mean 1.79, SD 0.41) scored the highest in confidence level followed by "treatment received for transplant" (mean 1.75, SD 0.46); meanwhile, information on "community resources for long-term effects of disease" (mean 1.14, SD 0.72) followed by "strategies for treating long-term physical effects of your treatment" (mean 1.15, SD 0.71) scored the lowest in confidence level (Figure 2). There were negative correlations between CTXD and PCS/MCS (P<0.001) and positive correlation between CSI and PCS/MCS (P<0.001). Different age groups at transplant (<65, 65-<70, vs. ≥70), history of chronic graft-versus-host disease, and enrollment time from transplant (≤2 vs. >2 years) showed no apparent effect on CTXD or CSI overall scores. Conclusion: Older alloHCT survivors report low level of cancer- and treatment-related distress and a relatively high level of CSI. Physical and mental function were associated with lower distress and increased CSI. Survivorship intervention needs in older alloHCT recipients include management of fatigue, education on long-term effects, and improving knowledge of and access to resources for long-term recovery and reintegration to society. The CTXD and CSI scales provide opportunities to evaluate and tailor interventions to the needs of older survivors with the potential to improve alloHCT survivorship care for older adults. Figure 1 Figure 1. Disclosures Hong: Adaptive Biotechnology: Other: Current employment of my spouse. Farhadfar: Incyte: Consultancy. Shaw: Orca bio: Consultancy; mallinkrodt: Other: payments. Devine: Sanofi: Consultancy, Research Funding; Johnsonand Johnson: Consultancy, Research Funding; Orca Bio: Consultancy, Research Funding; Be the Match: Current Employment; Vor Bio: Research Funding; Tmunity: Current Employment, Research Funding; Magenta Therapeutics: Current Employment, Research Funding; Kiadis: Consultancy, Research Funding. Wingard: Merck: Consultancy; AlloVir: Consultancy; Celgene: Consultancy; Shire: Consultancy; Janssen: Consultancy; Cidara Therapeutics: Consultancy. Majhail: Anthem, Inc: Consultancy; Incyte Corporation: Consultancy.

Patients-centered SurvivorShIp care plan after Cancer treatments based on Big Data and Artificial Intelligence technologies (PERSIST): a multicenter study protocol to evaluate efficacy of digital tools supporting cancer survivors

Background It is encouraging to see a substantial increase in individuals surviving cancer. Even more so since most of them will have a positive effect on society by returning to work. However, many cancer survivors have unmet needs, especially when it comes to improving their quality of life (QoL). Only few survivors are able to meet all of the recommendations regarding well-being and there is a body of evidence that cancer survivors’ needs often remain neglected from health policy and national cancer control plans. This increases the impact of inequalities in cancer care and adds a dangerous component to it. The inequalities affect the individual survivor, their career, along with their relatives and society as a whole. The current study will evaluate the impact of the use of big data analytics and artificial intelligence on the self-efficacy of participants following intervention supported by digital tools. The secondary endpoints include evaluation of the impact of patient trajectories (from retrospective data) and patient gathered health data on prediction and improved intervention against possible secondary disease or negative outcomes (e.g. late toxicities, fatal events). Methods/design The study is designed as a single-case experimental prospective study where each individual serves as its own control group with basal measurements obtained at the recruitment and subsequent measurements performed every 6 months during follow ups. The measurement will involve CASE-cancer, Patient Activation Measure and System Usability Scale. The study will involve 160 survivors (80 survivors of Breast Cancer and 80 survivors of Colorectal Cancer) from four countries, Belgium, Latvia, Slovenia, and Spain. The intervention will be implemented via a digital tool (mHealthApplication), collecting objective biomarkers (vital signs) and subjective biomarkers (PROs) with the support of a (embodied) conversational agent. Additionally, the Clinical Decision Support system (CDSS), including visualization of cohorts and trajectories will enable oncologists to personalize treatment for an efficient care plan and follow-up management. Discussion We expect that cancer survivors will significantly increase their self-efficacy following the personalized intervention supported by the m-HealthApplication compared to control measurements at recruitment. We expect to observe improvement in healthy habits, disease self-management and self-perceived QoL. Trial registration ISRCTN97617326. https://doi.org/10.1186/ISRCTN97617326. Original Registration Date: 26/03/2021.

Pregnancy After Breast Cancer: A Systematic Review and Meta-Analysis

PURPOSE Many patients and physicians remain concerned about the potential detrimental effects of pregnancy after breast cancer (BC) in terms of reproductive outcomes and maternal safety. This systematic review and meta-analysis aimed at providing updated evidence on these topics. METHODS A systematic literature review was conducted to identify studies including patients with a pregnancy after BC (PROSPERO number CRD42020158324). Likelihood of pregnancy after BC, their reproductive outcomes, and maternal safety were assessed. Pooled relative risks, odds ratios (ORs), and hazard ratios (HRs) with 95% CIs were calculated using random effects models. RESULTS Of 6,462 identified records, 39 were included involving 8,093,401 women from the general population and 112,840 patients with BC of whom 7,505 had a pregnancy after diagnosis. BC survivors were significantly less likely to have a subsequent pregnancy compared with the general population (relative risk, 0.40; 95% CI, 0.32 to 0.49). Risks of caesarean section (OR, 1.14; 95% CI, 1.04 to 1.25), low birth weight (OR, 1.50; 95% CI, 1.31 to 1.73), preterm birth (OR, 1.45; 95% CI, 1.11 to 1.88), and small for gestational age (OR, 1.16; 95% CI, 1.01 to 1.33) were significantly higher in BC survivors, particularly in those with previous chemotherapy exposure, compared with the general population. No significantly increased risk of congenital abnormalities or other reproductive complications were observed. Compared to patients with BC without subsequent pregnancy, those with a pregnancy had better disease-free survival (HR, 0.66; 95% CI, 0.49 to 0.89) and overall survival (HR, 0.56; 95% CI, 0.45 to 0.68). Similar results were observed after correcting for potential confounders and irrespective of patient, tumor, and treatment characteristics, pregnancy outcome, and timing of pregnancy. CONCLUSION These results provide reassuring evidence on the safety of conceiving in BC survivors. Patients' pregnancy desire should be considered a crucial component of their survivorship care plan.

Genetic testing documentation in survivorship care plans in patients with breast cancer.

e24110 Background: Genetic testing results for germline mutations impact care of cancer survivors, thus are important to include in a survivorship care plan (SCP). In 2014, the Commission on Cancer adopted the American Society of Clinical Oncology’s SCP template and included a section on cancer genetic testing and results. However, data on its implementation is scant. We assessed documentation of genetic testing results in SCPs in various genetic test result groups and by primary oncology treatment team (PT) and consulting survivorship team (ST). Methods: We conducted a retrospective chart review of breast cancer patients who had a survivorship visit at our institution from February 2015 to January 2020, were seen by a genetic counselor (GC), and had genetic testing for germline mutations for hereditary predisposition to cancer (GGT). We compared the extent of documentation of GGT between the PT and ST’s SCPs, and among result categories (positive, negative, and variant of uncertain significance (VUS)) for occurrence of genetic testing, name of panel tested, GC recommendations, GC name/contact information, and name of gene involved and site of mutation (when applicable). Results: Among 398 women with breast cancer (DCIS 3%, Stage I 47%, Stage II 40%, Stage III 10%), median age was 49 years (range 27-77 years); 91% were non-Hispanic white, 4.7% black, 2.7% Asian, and 1% were Hispanic. GGT was documented in 93.7% of SCPs overall. GGT results were positive in 12.8%, negative in 65.8%, and VUS in 21.4%. The ST (75% SCPs) more often included GGT documentation in SCP as compared to PT (95.7% vs 87.9%, p = 0.006). There was no difference in GGT documentation by result category (positive 96.1%, negative 92.4%, VUS 96.5%, p = 0.3). GGT documentation was more detailed by ST as compared to PT, with name of panel tested included in 97% vs 92% of SCPs (p < 0.001). Of those with positive or VUS results, the name of the involved gene was included in 95% vs 77% (p = 0.003), and the site of mutation in 82% vs 48% (p < 0.001) of SCPs (ST vs PT). Only 56% of SCPs in the positive results group included all GC’s screening and follow up recommendations, while 84.7% in the VUS and 92% in the negative results group included them (p < 0.001). GC name/contact information were more often documented in ST’s SCPs (66% vs 8%; p < 0.001), with overall reporting being low in all result categories (positive 49%, negative 54%, VUS 48%). Conclusions: Overall, SCPs were likely to have documentation of GGT occurrence, name of tested panel and involved genes, but less frequently included the specific mutation identified, GC contact information, or GC recommendations for those with positive results. Documentation tended to be more complete for SCPs performed by ST rather than by PT. The causes of this discrepancy are unclear and may be related to different levels of comfort with and knowledge of GGT. Further study is needed to identify knowledge gaps and processes to improve documentation of GGT in SCPs.

Internal medicine residents’ awareness on cancer survivorship care plan: A cross sectional study.

e23011 Background: Survivorship care plans (SCPs) is recommended as a tool for communication between oncologists and primary care physicians. According to the Institute of Medicine, it is necessary to lead a cultural shift to provide SCPs to all cancer survivors to improve the transition from the oncology clinic to primary care practices. Studies suggest residency training curriculums for internal medicine (IM) are lacking education about cancer survivorship and SCPs. We aimed to assess the awareness of trainees toward SCPs. Methods: A survey was distributed to IM trainees in an outpatient setting. We stratified the descriptive analyses by program type (transitional [TY] and categorical [CT] trainees) and year of training. Differences in the proportions were tested appropriately. Analyses were conducted in R v3.6.2. Results: 37 trainees were interviewed; 32.4% were TY and 67.6% CT trainees. A 54% were PGY-1, 21.6% PGY-2, and 24.3% PGY-3. None of the trainees reported following a SCP for cancer-free patients nor to use SCP as a source to obtain cancer-related information. 78.3% and 92.6% reported that they were not taught during residency or medical school about SCPs, respectively. 84.8% informed that cancer-related information was inaccessible during the encounter with patients; sources cancer diagnosis and treatment information included: patients/family members (97.3%), outside records (83.8%), and oncology notes (86.5%). By program type, there was a statistically significant difference between TY v. CT groups (p = 0.017) regarding how often cancer-related issues were discussed with patients; the TY group mainly reported ‘Not at all’ whether CT were more likely to engage in discussion about cancer. Differences in the trainees’ comfort level answering patients concerns about cancer recurrence were observed between TY v. CT trainees but was not statistically significant (p = 0.864). Most common barriers to discuss cancer history and/or SCP were insufficient information from patients (83.8%), perceived inaccuracy from patients’ information (81.1%), unclear if patient has a SCP (81.1%), lack of SCP in medical record (75.7%), and trainees’ low medical knowledge about side effects of cancer therapies (70.3%). Conclusions: The awareness of cancer SCP among the IM trainees is limited, and many have not accessed or received training in SCPs. Efforts intended to facilitate SCP use and educate residents about cancer survivorship may be effective to increase the comfort level of trainees managing the growing number of survivors and improve transition from oncology to primary care clinics.[Table: see text]

Survey of caregiver needs after their loved ones completed cancer treatment.

e24048 Background: Many people with cancer have medical and psycho-social-sexual sequelae following completion of treatment, which can extend well in to the future and impact both caregivers and families. In response to the unmet needs of people with cancer, the Survivorship Care Plan (SCP) was proposed as a roadmap for patients starting from diagnosis and treatment and preparing them for future care, both inside and beyond oncology-specific issues. However, the SCP does not address needs of families or caregivers, nor was it meant to. We sought to identify the needs of caregivers to determine whether a tailored SCP for the caregiver (SCP-C) should be considered. Methods: People who were at least 6 months out from the end of treatment were invited to participate, along with their designated caregiver. Volunteers with cancer completed the National Comprehensive Cancer Network Survivorship Assessment Survey at the time of consent. Caregivers participated in a semi-structured interview using an adaptation of the Veterans Affairs Caregiver Self-Assessment worksheet, supplemented by open-ended questions. Descriptive statistics were used; categorical variables were compared using chi-square or Fisher’s Exact Test. Results: 24 dyads (patient and caregiver pairs) were enrolled. Median age for patients was 70 (60.7 to 73) and caregivers was 66 (52.2-72). Time since end of treatment was 32 months (9.7 to 69.6) for patients and 32.8 months (8.3 to 51.3) for caregivers. The majority of patient respondents were female (87.5%) and caregiver respondents were male (70.8%); the majority had early-stage disease (63%). About 65% of caregivers were spouses and 74% of them lived with the person with cancer. 75% of caregivers spent 6 months to 3 years as a caregiver. They reported multiple types of support to patients, including help with ADLs, transportation, medical management and emotional support, regardless of time elapsed since their loved one’s diagnosis. Intimate support was significantly less among married couples less than 3 years out from diagnosis (23 vs 73%, respectively, p < .05). 100% of caregivers reported that they understood the diagnosis and follow up plan. However, almost 20% felt they did not fully understand potential side effects of treatment. Caregivers coped well in all domains with the exception of maintaining mental and physical health; compared to those out 3 years or less, those out for longer were more likely to report doing well (90% vs 45%, p < 0.5). Conclusions: Although caregivers reported high satisfaction with cancer-specific information, a large minority reported issues related to the side effects of treatment. In addition, while caregivers did well after completing treatment, those still within the first 3 years of the index diagnosis reported more issues with physical and mental health. These data point toward targeted resources that could be provided specific in an SCP-C.