Cost-Utility Analysis of Geriatric Assessment and Management in Older Adults With Cancer: Economic Evaluation Within 5C Trial.

PURPOSE: Geriatric assessment (GA) is a guideline-recommended approach to optimize cancer management in older adults. We conducted a cost-utility analysis alongside the 5C randomized controlled trial to compare GA and management (GAM) plus usual care (UC) against UC alone in older adults with cancer. METHODS: The economic evaluation, conducted from societal and health care payer perspectives, used a 12-month time horizon. The Canadian 5C study randomly assigned patients to receive GAM or UC. Quality-adjusted life-years (QALYs) were measured using the EuroQol five dimension-5L questionnaire and health care utilization using cost diaries and chart reviews. We evaluated the incremental net monetary benefit (INMB) for the full sample and preselected subgroups. RESULTS: A total of 350 patients were included, of whom 173 received GAM and 177 UC. At 12 months, the average QALYs per patient were 0.728 and 0.751 for GAM and UC, respectively (ΔQALY, -0.023 [95% CI, -0.076 to 0.028]). Considering a societal perspective, the total average costs (in 2021 Canadian dollars) per patient were $46,739 and $45,177 for GAM and UC, respectively (ΔCost, $1,563 [95% CI, -$6,583 to $10,403]). At a cost-effectiveness threshold of $50,000/QALY, GAM was not cost-effective compared with UC (INMB, -$2,713 [95% CI, -$11,767 to $5,801]). The INMB was positive ($2,984 [95% CI, -$7,050 to $14,179]; probability of being cost-effective, 72%) for patients treated with curative intent, but remained negative for patients treated with palliative intent (INMB, -$9,909 [95% CI, -$24,436 to $4,153]). Findings were similar considering a health care payer perspective. CONCLUSION: To our knowledge, this is the first cost-utility analysis of GAM in cancer. GAM was cost-effective for patients with cancer treated with curative but not with palliative intent. The study provides further considerations for future adoption of GAM in practice.

Theory-based behavior change intervention to increase uptake of risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 pathogenic variant: The PREVENT randomized controlled trial.

OBJECTIVE: To evaluate the effect of a theory-based behavioral intervention delivered by genetic counselors on the uptake of risk-reducing salpingo-oophorectomy (RRSO) at 12 and 24 months by women with a BRCA1 or BRCA2 pathogenic variant (PV) compared to women who received usual care. METHODS: In this two-arm, multi-site randomized controlled trial participants were randomized to receive a theoretically-guided behavioral telephone intervention or usual care. Outcome data were collected at 12 and 24 months. Participants in the usual care arm were offered the intervention after 12 months. RESULTS: Data on 107 participants were included in the analysis. There was no significant difference in the proportion of women who had a RRSO by 1 year (28.6%- intervention; 22.9%- usual care (p = 0.54)). At 1 year, women who received the intervention had significantly lower mean decisional conflict (pinteraction <0.001) and a higher mean knowledge score at one-year compared to usual care (pinteraction <0.001). At 2 years, 53.9% of participants in the intervention arm had RRSO compared to 32.6% in usual care (p = 0.05). CONCLUSIONS: A theory-based behavioral intervention delivered by genetic counselors to women with a BRCA PV who chose not to have the recommended RRSO was effective at reducing decisional conflict and increasing knowledge in women with a BRCA1 or BRCA2 PV.

Predictors and effects of toxicity experienced by older adults with cancer receiving systemic therapy in a randomized clinical trial of geriatric assessment.

INTRODUCTION: Older adults represent a large segment of the oncology population, however, they remain underrepresented in clinical research. Treatment of older adults is often extrapolated using data from younger and fitter patients, which may not be appropriate. Furthermore the implications of toxicity from treatment can be greater for this population. Predicting toxicity from treatment and its effect on quality of life and functional status for older adults therefore is important. MATERIALS AND METHODS: We analyzed data from a clinical trial of geriatric assessment and management for Canadian elders with cancer (5C study). We assessed whether the baseline Cancer and Aging Research Group (CARG) toxicity score, G8 score, and Eastern Cooperative Oncology Group (ECOG) performance predicted grade 3-5 toxicity using logistic regression and pattern mixture models. We also assessed the impact of toxicity on quality of life and functional decline. Patients were followed for six months. RESULTS: Three hundred sixteen patients were included. Mean age was 76 years old and 40% of patients were female. One hundred nineteen patients (38%) experienced at least one grade 3-5 toxicity. Neither the CARG toxicity score, G8, or ECOG were predictive of grade 3-5 toxicity. Patients who experienced grade 3-5 toxicity were more likely to have functional impairments over time (odds ratio 3.71, p = 0.03). However, they maintained their quality of life. DISCUSSION: In this secondary analysis of a randomized controlled trial of geriatric assessment and management we did not find any predictors of grade 3-5 toxicity. Patients who did experience toxicity were more likely to report functional decline over time. Older adults who do experience treatment related toxicity may benefit from increased supports. CLINICAL TRIAL INFORMATION: NCT0315467.

Implementing geriatric assessment and management for older Canadians with cancer: Adherence to and satisfaction with the intervention, results of the 5C study.

INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.

Intensity of end-of-life care among children with life-threatening conditions: a national population-based observational study.

BACKGROUND: Children with life-threatening conditions frequently experience high intensity care at the end of life, though most of this research only focused on children with cancer. Some research suggests inequities in care provided based on age, disease type, socioeconomic status, and distance that the child lives from a tertiary hospital. We examined: 1) the prevalence of indicators of high intensity end-of-life care (e.g., hospital stays, intensive care unit [ICU] stays, death in ICU, use of cardiopulmonary resuscitation [CPR], use of mechanical ventilation) and 2) the association between demographic and diagnostic factors and each indicator for children with any life-threatening condition in Canada. METHODS: We conducted a population-based retrospective cohort study using linked health administrative data to examine care provided in the last 14, 30, and 90 days of life to children who died between 3 months and 19 years of age from January 1, 2008 to December 31, 2014 from any underlying life-threatening medical condition. Logistic regression was used to model the association between demographic and diagnostic variables and each indicator of high intensity end-of-life care except number of hospital days where negative binomial regression was used. RESULTS: Across 2435 child decedents, the most common diagnoses included neurology (51.1%), oncology (38.0%), and congenital illness (35.9%), with 50.9% of children having diagnoses in three or more categories. In the last 30 days of life, 42.5% (n = 1035) of the children had an ICU stay and 36.1% (n = 880) died in ICU. Children with cancer had lower odds of an ICU stay (OR = 0.47; 95% CI = 0.36-0.62) and ICU death (OR = 0.37; 95%CI = 0.28-0.50) than children with any other diagnoses. Children with 3 or more diagnoses (vs. 1 diagnosis) had higher odds of > 1 hospital stay in the last 30 days of life (OR = 2.08; 95%CI = 1.29-3.35). Living > 400 km (vs < 50 km) from a tertiary pediatric hospital was associated with higher odds of multiple hospitalizations (OR = 2.09; 95%CI = 1.33-3.33). CONCLUSION: High intensity end of life care is prevalent in children who die from life threatening conditions, particularly those with a non-cancer diagnosis. Further research is needed to understand and identify opportunities to enhance care across disease groups.

Utilization of individual components of enhanced recovery after surgery (ERAS) protocol improves post-operative outcomes in adolescent idiopathic scoliosis: a blueprint for progressive adoption of ERAS.

PURPOSE: Enhanced recovery after surgery [ERAS] is an approach for standardization of perioperative care aimed at improving patient outcomes. The primary aim of this study was to determine if length of stay (LOS) differed by protocol type (ERAS vs. non-ERAS [N-ERAS]) in patients undergoing surgery for adolescent idiopathic scoliosis (AIS). METHODS: A retrospective cohort study was conducted. Patient characteristics were collected and compared between groups. Differences in LOS were assessed using regression adjusting for age, sex, BMI, pre-surgical Cobb angle, levels fused and year of surgery. RESULTS: Fifty nine ERAS patients were compared to 81 N-ERAS patients. Patients were comparable in their baseline characteristics. Median LOS was 3 days (IQR = 3-4) for the ERAS group, compared to 5 days (IQR = 4-5) for the N-ERAS group (p < 0.001). The ERAS group had a significantly lower adjusted rate of stay (RR = 0.75; 95% CI = 0.62-0.92). The ERAS group had significantly lower average pain on post-operative days 0 (least-squares-mean [LSM] 2.66 vs. 4.41, p < 0.001), POD1 (LSM 3.12 vs. 4.48, p < 0.001) and POD5 (LSM 2.84 vs. 4.42, p = 0.035). The ERAS group had lower opioid consumption (p < 0.001). LOS was predicted by the number of protocol elements received; those receiving two (RR = 1.54 95% CI = 1.05-2.24), one (RR = 1.49; 95% CI = 1.09-2.03) or none (RR = 1.60, 95% CI = 1.21-2.13) had significantly longer rates of stay than those receiving all four. CONCLUSION: Adoption of modified ERAS-based protocol for patients undergoing PSF for AIS led to significant reduction in LOS, average pain scores, and opioid consumption.

Location of death among children with life-threatening conditions: a national population-based observational study using the Canadian Vital Statistics Database (2008-2014).

BACKGROUND: Patterns in location of death among children with life-threatening conditions (e.g., cancer, genetic disorders, neurologic conditions) may reveal important inequities in access to hospital and community support services. We aimed to identify demographic, socioeconomic and geographic factors associated with variations in location of death for children across Canada with life-threatening conditions. METHODS: We used a retrospective observational cohort design and the Canadian Vital Statistics Database to identify children aged 19 years or younger who died from a life-threatening condition between Jan. 1, 2008, and Dec. 31, 2014. We used multivariable logistic regression to determine predictors of in-hospital death for children aged 1 month to 19 years, and for neonates younger than 1 month. RESULTS: Overall, 13 115 decedents younger than 19 years had life-threatening conditions. Of 5250 children and 7865 neonates, 74.2% and 98.1%, respectively, died in hospital. Among children, we found a higher proportion of hospital deaths in the lowest (v. highest) income quintile (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.28-1.97), and a lower proportion among children living more than 400 km (v. < 50 km) from a pediatric hospital (OR 0.73, 95% CI 0.65-0.86). Compared with Ontario, hospital death was most common in Quebec (OR 1.38, 95% CI 1.14-1.67) and least common in British Columbia (OR 0.43, 95% CI 0.34-0.53). Compared with an oncologic cause of death, all causes except neurologic and metabolic conditions had significantly higher odds of dying in hospital. INTERPRETATION: In addition to demographics, we identified socioeconomic and geographic differences in location of death, suggesting potential inequities in access to high-quality care at the end of life. Health care policies and practices must ensure equitable access to services for children across Canada, particularly at the end of their life.

Patient-reported outcomes associated with reflex BRCA1/2 tumor and subsequent germline panel genetic testing for high-grade serous ovarian cancer.

Reflex genetic testing of tumor tissue is being completed to direct cancer treatment; however, the patient impact of this genetic testing model is unknown. This survey study evaluates psychological outcomes following tumor and germline genetic testing in individuals with a new diagnosis of high-grade serous ovarian cancer (HGSOC). Individuals were recruited from two hospitals in Toronto, Canada. Participants completed surveys 1 week after receiving tumor results and 1 week after receiving germline results (which included genetic counseling). Outcomes included cancer-related distress (Impact of Events Scale: IES), genetic testing-related distress (Multidimensional Impact of Cancer Risk Assessment: MICRA), and patient satisfaction. Paired t-tests were used to evaluate differences in outcomes following each genetic test result; Cohen's d was used to evaluate effect size. Subgroup analyses were undertaken according to age at diagnosis (<60 years vs. ≥60 years) and test results (any positive vs. both negative). McNemar's test assessed differences in satisfaction. Fifty-two individuals were included in the analyses. Mean IES scores were similar following disclosure of tumor and germline results (27.39 vs. 26.14; p = 0.481; d = 0.101). Compared to following tumor result disclosure, MICRA scores were significantly lower following receipt of germline results with genetic counseling (27.23 vs. 22.69; p = 0.007; d = 0.435). Decreases in MICRA scores from tumor to germline result disclosure were greater for those diagnosed <60 years or those who received only negative test results. Most individuals were satisfied/highly satisfied following tumor (85.7%) and germline (89.8%) results disclosure (p = 0.774). Reflex tumor, and subsequent germline, genetic testing is a new model of care for cancer patients. In our cohort, genetic testing-related distress decreased significantly following receipt of germline results with genetic counseling, especially for individuals diagnosed under 60 years and those receiving only negative results. Most individuals were satisfied with this model of care.

Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial.

PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.

The Development of Geriatric Assessment and Intervention Guidelines for an Online Geriatric Assessment Tool: A Canadian Modified Delphi Panel Study.

BACKGROUND: There are no guidelines available for what assessment tools to use in a patient's self-completed online geriatric assessment (GA) with management recommendations. Therefore, we used a modified Delphi approach with Canadian expert clinicians to develop a consensus online GA plus recommendations tool. METHODS: The panel consisted of experts in geriatrics, oncology, nursing, and pharmacy. Experts were asked to rate the importance and feasibility of assessments and interventions to be included in an online GA for patients. The items included in the first round were based on guidelines for in-person GA and literature review. The first two rounds were conducted using an online survey. A virtual 2 h meeting was held to discuss the items where no consensus was reached and then voted on in the final round. RESULTS: 34 experts were invited, and 32 agreed to participate. In round 1, there were 85 items; in round 2, 50 items; and in round 3, 25 items. The final tool consists of fall history, assistive device use, weight loss, medication review, need help taking medication, social supports, depressive symptoms, self-reported vision and hearing, and current smoking status and alcohol use. CONCLUSION: This first multidisciplinary consensus on online GA will benefit research and clinical care for older adults with cancer.

Patterns of Concerns Among Hematological Cancer Survivors.

BACKGROUND: Advances in treatment for hematological cancers warrant greater attention on survivorship concerns. OBJECTIVE: The aims of this study were to describe survivorship concerns among hematological cancer survivors, identify subgroups of survivors with distinct classes of concerns, and examine sociodemographic and clinical differences across subgroups. METHODS: We conducted a cross-sectional analysis of data from 1160 hematological cancer survivors, who rated their degree of concern regarding 20 physical, emotional, and practical changes. Clusters of concerns were identified using latent class analysis. Associations between respondent characteristics and cluster membership were calculated using multinomial logistic regression. RESULTS: Survivors had a mean of 7.5 concerns (SD, 4.6; range, 0-19), the most frequent being fatigue/tiredness (85.4%); anxiety, stress, and worry about cancer returning (70.2%); and changes to concentration/memory (55.4%). Three distinct classes of concerns were identified: class 1 (low, 47.0%), characterized by low endorsement of most concerns, apart from fatigue; class 2 (moderate, 32.3%), characterized by high endorsement of a combination of concerns across domains; and class 3 (high, 20.7%), characterized by the highest number of concerns out of the 3 identified classes, including greater endorsement of concerns relating to sexual well-being. Class membership was differentiated by survivor age, sex, marital status, and diagnosis. CONCLUSIONS: Three distinct patterns of concerns were detected in a large sample of hematological cancer survivors. Patterns of concerns could be differentiated by survivor characteristics. IMPLICATIONS FOR PRACTICE: Our study highlights the concerns experienced by hematological cancer survivors and provides support for a tailored biopsychosocial approach to survivorship care in this context.

High-risk health behaviours of pregnancy-planning women and men: Is there a need for preconception care?

AIM: To examine the prevalence and predictors of high-risk health behaviours in pregnancy-planning women and men. DESIGN: Cross-sectional online survey. SETTING: Canada. PARTICIPANTS: Canadian women (n = 529) and men (n = 92) self-identifying as planning a pregnancy within 5 years, recruited through email and social media. MEASUREMENTS: Health behaviours examined included smoking, alcohol and cannabis use, internet addiction, low physical activity, overweight and obesity, eating habits, and sleeping less than 6 h/night. FINDINGS: Prevalent preconception high-risk health behaviours in both women and men were low physical activity (women 44.9%, men 38.8%), overweight and obesity (women 52.5%, men 64.9%), and unhealthy eating habits (women 42.8%, men 55.8%), while men had a significantly higher prevalence of cigarette smoking (women 4.9%, men 12.0%, p=.008) and alcohol use (women 19.6%, men 40.7%, p<.001). The mean number of high-risk health behaviours in women was 2.1 (SD=1.37) compared to 2.5 (SD=1.37) in men (p=.001). Significant predictors of a higher number of high-risk health behaviours included multiparity, low education and depression in women, and higher perceived stress in men. KEY CONCLUSIONS: There is a high prevalence of high-risk health behaviours in women and men actively trying to conceive or planning to achieve pregnancy soon. Health promotion should be a key component of preconception health interventions for both women and men as part of a life course approach to optimizing population health. IMPLEMENTATION FOR PRACTICE: Findings demonstrate modifiable targets for preconception programs and factors that can be used to identify at-risk groups requiring intervention. Individual-level interventions require societal changes that promote healthy behaviours through better health policies and strong public health messaging.

Impact of rapid genetic testing for BRCA1 and BRCA2 at time of breast cancer diagnosis on psychosocial functioning.

PURPOSE: Many women are being offered rapid genetic testing (RGT) for cancer predisposition genes, at the time of breast cancer diagnosis prior to surgery. The goal of this study was to determine if psychosocial functioning was affected in women receiving RGT for BRCA1 and BRCA2 at the time of breast cancer diagnosis. METHODS: Participants were women with invasive breast cancer diagnosed between 2013 and 2018, at four centres in Toronto, Canada. Eligible women were referred into the study by their surgeon at the time of diagnosis. Participants received pre-test genetic counselling and were offered RGT for BRCA1 and BRCA2. Standardized questionnaires (Impact of Event Scale and Hospital Anxiety and Depression Scale) were completed before genetic counselling, and follow-up questionnaires at one-week and one-year post-genetic test result disclosure (higher scores indicate higher symptoms). RESULTS: 1007 women had RGT; 60 women (6.0%) were found to have a BRCA1 or BRCA2 mutation, 80 women (7.9%) had a VUS, and 867 (86.1%) had a negative test result. At one-week post-testing, there were no differences in distress (p = 0.32), anxiety (p = 0.14), or depression (p = 0.42) between women with a BRCA1/2 mutation and those with a negative result. At one year, there were no differences in distress (p = 0.75) or anxiety (p = 0.13) between women with a BRCA1 or BRCA/2 mutation and those with a negative result. However, women with a BRCA1 or BRCA2 mutation had significantly lower depression scores compared to women with a negative result (p = 0.03). CONCLUSION: For women who have RGT for BRCA1 and BRCA2 at the time of breast cancer diagnosis, identifying a BRCA1 or BRCA2 mutation does not impair psychosocial functioning in the short or long term.

A comparison of educational events for physicians and nurses in Australia sponsored by opioid manufacturers.

BACKGROUND: Educational activities for physicians sponsored by opioid manufacturers are implicated in the over- and mis-prescribing of opioids. However, the implications of promotion to nurses are poorly understood. Nurses play a key role in assessing pain, addressing the determinants of pain, and administering opioid medications. We sought to understand the nature and content of pain-related educational events sponsored by opioid manufacturers and to compare events targeting physicians and nurses. METHODS: We conducted a cross sectional, descriptive analysis of pharmaceutical company reports detailing 116,845 sponsored educational events attended by health professionals from 2011 to 2015 in Australia. We included events that were sponsored by manufacturers of prescription opioid analgesics and were pain related. We compared event characteristics across three attendee groups: (a) physicians only; (b) at least one nurse in attendance; and (c) nurses only. We coded the unstructured data using iteratively generated keywords for variables related to location, format, and content focus. RESULTS: We identified 3,411 pain-related events sponsored by 3 companies: bioCSL/CSL (n = 15), Janssen (n = 134); and Mundipharma (n = 3,262). Pain-related events were most often multidisciplinary, including at least one nurse (1,964/3,411; 58%); 38% (1,281/3,411) included physicians only, and 5% (166/3,411) nurses only. The majority of events were held in clinical settings (61%) and 43% took the form of a journal club. Chronic pain was the most common event topic (26%) followed by cancer pain and palliative care (18%), and then generic or unspecified references to pain (15%); nearly a third (32%) of event descriptions contained insufficient information to determine the content focus. Nurse-only events were less frequently held in clinical settings (32%; p < .001) and more frequently were product launches (17%; p < .001) and a significantly larger proportion focused on cancer or palliative care (33%; p < .001), generic pain topics (27%; p < .001), and geriatrics (25%; p < .001) than physician-only or multidisciplinary events. DISCUSSION: Opioid promotion via sponsored educational events extends beyond physicians to multidisciplinary teams and specifically, nurses. Despite lack of evidence that opioids improve outcomes for long-term chronic non-cancer pain, hundreds of sponsored educational events focused on chronic pain. Regulators should consider the validity of distinguishing between pharmaceutical companies' "promotional" and "non-promotional" activities.

Late cognitive outcomes among allogeneic stem cell transplant survivors: follow-up data from a 6-year longitudinal study.

CONTEXT: Survivors of allogeneic hematopoietic stem cell transplantation (alloHCT) may experience cognitive impairment over time post-treatment, but early identification of these individuals is limited. OBJECTIVES: We previously reported a prospective evaluation of cognitive functioning over the first 6 months of alloHCT. Here, we report an extension of this study, with specific aims to (1) evaluate the trajectory of cognitive outcomes over the first 6 years post-alloHCT, and (2) determine the extent to which late cognitive impairment is predicted by earlier impairment. METHODS: Participants completed objective and subjective cognitive measures before alloHCT, and at 100 days, 6 months, and 6 years post-alloHCT. Outcome trajectories were determined using linear mixed effects models. Relationships between early and late cognitive impairment were assessed using logistic regression and receiver operator curves. RESULTS: This analysis is based on longitudinal data from 59 participants, of whom 20 provided data at 6-year follow-up. Longitudinal models revealed an overall stability of cognitive outcomes over time, except for psychomotor efficiency/processing speed performance, which significantly improved (p = .049). However, poor learning/memory and cognitive complaints were persistently observed. At 6 years, 40% of relapse-free survivors met the impairment criteria. Impairment at 100 days was associated with impairment 6 years (OR = 20.00, p = .028) and demonstrated good accuracy in classifying those who were impaired and not impaired at 6 years (AUC = .79; 95% CI = .56-1.00). CONCLUSION: Poor cognitive outcomes among long-term alloHCT survivors are associated with cognitive functioning during the early post-treatment period. Early identification of survivors likely to experience poor cognitive outcomes may be possible, enabling timely intervention to mitigate long-term negative impacts.

Examining Predictors of Fear of Cancer Recurrence Using Leventhal's Commonsense Model: Distinct Implications for Oncology Nurses.

BACKGROUND: Fear of cancer recurrence (FCR) is a common concern for survivors. Oncology nurses have a unique opportunity to identify survivors at increased risk of heightened FCR. Understanding predictors of FCR would be useful for this purpose; however, results about FCR predictors are inconsistent. OBJECTIVE: To examine empirically inconsistent predictors of FCR as guided by Leventhal's Commonsense Model. METHODS: A cross-sectional survey design was used to assess FCR, sociodemographic and clinical characteristics, and characteristics of the self (self-esteem and generalized expectancies) among cancer survivors. Structural equation modeling was used to examine predictors of FCR. RESULTS: Among 1001 participants, the mean time since diagnosis was 9.07 years, and most were diagnosed with breast cancer (65.93%). The strongest predictor of higher FCR was belief that knowing someone with a recurrence affects one's own level of FCR, although knowing someone with a recurrence actually predicted lower FCR. Other significant predictors of higher FCR were having 1 or more symptoms attributed to cancer, lower self-esteem, younger age, female gender, lower pessimism, longer time since diagnosis, and active follow-up at the survivorship clinic. CONCLUSION: Cancer survivors' perceptions are among an important series of variables that may predict higher levels of FCR. Oncology nurses are uniquely situated to identify the subset of cancer survivors with levels of FCR requiring professional intervention. IMPLICATIONS FOR PRACTICE: Oncology nurses can use the predictors indicated in this study to identify survivors with greatest need for coping with FCR to facilitate expedient intervention and/or referral to psychosocial providers.

Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial.

INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.

Factor structure of the Quality of Children's Palliative Care Instrument (QCPCI) when complete by parents of children with cancer.

BACKGROUND: Currently available indicators of quality pediatric palliative care tend to focus on care provided during the end-of-life period rather than care provided throughout the disease trajectory. We adapted a previously developed instrument focused on mothers' perspectives on the quality of end-of-life care and assessed its psychometric properties with mothers and fathers of children with cancer at any stage of the illness. METHODS: Four subscales were included in the analysis: Connect with Families, Involve Parents, Share Information Among Health Professionals, Support Siblings. The number of items across the four subscales was reduced from 31 to 15. We conducted confirmatory factor analysis, composite reliability, internal consistency, and tests of correlation between the overall scale and subscale totals and a separate question inquiring about overall quality of care. Measurement invariance between mothers and fathers was assessed. RESULTS: A total of 533 mothers and fathers completed the survey. The four-factor model was confirmed and there were significant correlations between each subscale score and responses to the overall item on care quality. Cronbach's alpha was adequate for the scale as a whole and for each subscale ranging from 0.78 to 0.90. We also found the factor structure, means, and intercepts were similar across mothers and fathers, suggesting the tool can be used by both groups. CONCLUSIONS: There is evidence for a four-factor structure within a new Quality of Children's Palliative Care Instrument (QCPCI) with demonstrated reliability when used with mothers and fathers of children with cancer. Ongoing assessment of the psychometric properties is needed, including testing in additional populations. However, our initial findings suggest that the QCPCI may be a helpful tool for assessing the quality of palliative care for pediatric patients anywhere along the disease trajectory from the perspective of parents.

Health status, emergency department visits, and oncologists' feedback: An analysis of secondary endpoints from a randomized phase II geriatric assessment trial.

PURPOSE: Geriatric Assessment (GA) can help uncover previously unknown health issues and recommend tailored interventions to optimize outcomes; however, no completed randomized trial has examined the impact of GA on utility-based health status, healthcare use, and oncologists' opinions about GA. We examined these secondary outcomes of a randomized phase II trial. METHODS: A planned analysis of secondary outcomes of a two-group parallel single-blind randomized phase II trial of GA (ClinicalTrials.gov Identifier:NCT02222259) recruited patients ≥ age 70, diagnosed with stage II-IV breast/gastrointestinal/genitourinary cancer within six weeks of beginning chemotherapy at the Princess Margaret Cancer Centre, Toronto, Canada. Descriptive analyses using intent-to-treat were conducted for health status (EuroQol EQ-5D-3L) and healthcare utilization (patient self-report). Oncologist opinions were captured via open-ended interviews and summarized. RESULTS: A total of 95 patients who met the inclusion criteria were approached; 61 of them consented (64%). For health status, at all time-points, there were no significant differences between the two groups. The number of emergency department and family physician visits was low overall; there were no statistically significant differences between the two groups at any time point. All interviewed oncologists (eight of fourteen invited) were satisfied with the intervention, but wanted more straightforward recommendations and earlier GA results. CONCLUSIONS: No difference was found in terms of relationships between GA and utility-based health status or GA and healthcare use. Underreporting of healthcare use was possible. Oncologists welcome GA feedback and prefer to receive it in pre-treatment decision context. Larger trials with earlier GA are warranted.

Examining the dimensionality of the Fear of Cancer Recurrence Inventory.

OBJECTIVE: Fear of cancer recurrence (FCR) is a common concern among cancer survivors, and the Fear of Cancer Recurrence Inventory (FCRI) is a frequently used measure to assess FCR. Given that the dimensionality of FCR has received recent debate, the overall goal of this secondary analysis was to re-examine the dimensionality of the FCRI using confirmatory factor analyses (CFA) to compare models of FCR, using data from a large sample of cancer survivors. METHODS: Three models of FCR (including unidimensional and multidimensional models of the FCRI) were informed by the literature and proposed a priori. Separate CFAs were conducted to test the fit of each model to the data, and models with acceptable fits were compared. RESULTS: Of all the tested FCR models, a multidimensional first-order model aligned with the originally developed 7-subscale FCRI revealed the best fit to the data (χ2  = 3359.135, P < .0001, df = 795, RMSEA = 0.057 [0.055, 0.059], CFI = 0.897, TLI = 0.888). When this 7-factor structure was loaded onto a single, second-order factor of overall FCR, the model fit statistics were slightly poorer (χ2  = 3459.632, P < .0001, df = 807, RMSEA = 0.058 [0.056, 0.060], CFI = 0.893, TLI = 0.886). However, the difference between the models was significant (chi-square difference = 103.142, P < .0001, df = 12) indicating that the first-order model was a better fit to the data. CONCLUSIONS: These results align with empirical and theoretical literature that supports the use of the FCRI as a multidimensional scale. Implications of results are discussed in light of FCR conceptualization and measurement.