Implementation and evaluation of a smoking cessation checklist implemented within Australian cancer services.

INTRODUCTION: The detrimental impact of smoking tobacco can be mitigated when cancer patients quit smoking. Smoking cessation clinical pathways are inconsistently implemented within Australian cancer services. The aim of this study was to pilot test and evaluate the reach, adoption, and implementation of a smoking cessation checklist within oncology services. METHODS: The checklist was implemented over a 6-month period in medical and radiation oncology services at two metropolitan and one rural hospital. The RE-AIM framework guided the evaluation process. Implementation strategies included training, process mapping, and identifying champions. Evaluation measures included a clinical data audit, surveys, and semi-structured interviews with healthcare professionals (HCPs). RESULTS: Healthcare professionals (HCPs; N = 63; 41% oncologists, 32% nurses, 27% others) completed 1276 checklists with cancer patients between November 2019 and December 2020. Of the 126 (10%) identified current smokers, 34 (27%) accepted a referral to either Quitline, Nicotine Replacement Therapy, to a general practitioner or dedicated HCP for follow-up telephone support. There was variation in screening adoption by HCPs across the three hospitals, with 16%, 92% and 89.5% of patients screened respectively. Contextual factors, such as perceived commitment, role identity, and communication processes appeared to influence the outcomes. CONCLUSION: A checklist is a simple, effective, and versatile intervention used to standardise smoking cessation practices in medical and radiation oncology services. The checklist supports standardisation of referral practices to smoking cessation services for cancer patients by either oncologist and/or nurses.

Phase 2 Multicenter Study of Gantry-Based Stereotactic Radiotherapy Boost for Intermediate and High Risk Prostate Cancer (PROMETHEUS).

Objectives: To report feasibility, early toxicity, and PSA kinetics following gantry-based, stereotactic radiotherapy (SBRT) boost within a prospective, phase 2, multicenter study (PROMETHEUS: ACTRN12615000223538). Methods: Patients were treated with gantry-based SBRT, 19-20 Gy in two fractions delivered 1 week apart, followed by conventionally fractionated IMRT (46 Gy in 23 fractions). The study mandated MRI fusion for RT planning, rectal displacement, and intrafraction image guidance. Toxicity was prospectively graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4). Results: Between March 2014 and July 2018, 135 patients (76% intermediate, 24% high-risk) with a median age of 70 years (range 53-81) were treated across five centers. Short course (≤6 months) androgen deprivation therapy (ADT) was used in 36% and long course in 18%. Rectal displacement method was SpaceOAR in 59% and Rectafix in 41%. Forty-two and ninety-three patients were treated at the 19 Gy and 20 Gy dose levels, respectively. Median follow-up was 24 months. Acute grade 2 gastrointestinal (GI) and urinary toxicity occurred in 4.4 and 26.6% with no acute grade 3 toxicity. At 6, 12, 18, 24, and 36 months post-treatment the prevalence of late grade ≥2 gastrointestinal toxicity was 1.6, 3.7, 2.2, 0, and 0%, respectively, and the prevalence of late grade ≥2 urinary toxicity was 0.8, 11, 12, 7.1, and 6.3%, respectively. Three patients experienced grade 3 late toxicity at 12 to 18 months which subsequently resolved to grade 2 or less. For patients not receiving ADT the median PSA value pre-treatment was 7.6 ug/L (1.1-20) and at 12, 24, and 36 months post-treatment was 0.86, 0.36, and 0.20 ug/L. Conclusions: Delivery of a gantry-based SBRT boost is feasible in a multicenter setting, is well-tolerated with low rates of early toxicity and is associated with promising PSA responses. A second transient peak in urinary toxicity was observed at 18 months which subsequently resolved. Follow-up is ongoing to document late toxicity, long-term patient reported outcomes, and tumor control with this approach.

Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers.

AIM: Clinical trials play a critical role in advancing cancer care, but international research shows that few cancer patients, particularly culturally and linguistically diverse (CALD) patients, participate in trials. This limits generalizability of trial results and increases health disparities. This study aimed to establish rates and correlates of trial participation among CALD patients in South Western Sydney Local Health District (SWSLHD), a highly culturally diverse area. METHODS: Data from all cancer patients diagnosed and/or treated in SWSLHD from January 2006 to July 2016 were analyzed retrospectively. The primary outcome was trial enrolment among patients born in non-English speaking countries (CALD) versus English speaking countries (non-CALD). Multivariable logistic regression evaluated CALD status as a predictor of trial participation. Moderators of trial participation by the different CALD groups, namely those whose preferred language was English (CALD-PLE) or was not English (CALD-PLNE), were examined by testing interactions between CALD status and other demographic and clinical variables. RESULTS: A total of 19 453 patients were analyzed (54.9% non-CALD, 16.5% CALD-PLE, 18.5% CALD-PLNE). Overall, 7.4% of patients were enrolled in a trial. Trial participation was significantly lower in CALD patients than non-CALD patients (5.7% vs 8.4%; odds ratio [OR] = 0.80; 95% confidence interval [CI], 0.69-0.91; P = 0.001). CALD-PLNE patients were less likely to participate in trials than non-CALD (OR = 0.45; 95% CI, 0.36-0.56; P < 0.0001) and CALD-PLE patients (OR = 0.53; 95% CI, 0.67-0.41; P < 0.0001). CONCLUSIONS: Limited English proficiency seems particularly unfavorable to trial participation. Development and evaluation of strategies to overcome language barriers (e.g. simplified and translated multimedia participant information materials) is needed.

Obstacles to participation in randomised cancer clinical trials: a systematic review of the literature.

Accrual to clinical trials continues to be a problem in many countries including Australia despite its fundamental importance to the progress of evidence-based medicine. This paper reviews the current literature addressing the obstacles to accrual excluding those related to protocol design. An electronic search of the literature identified publications in oncology specifically addressing the obstacles to participation in clinical trials. This search was supplemented by searches of key oncology journals. Obstacles fall into three main categories - clinician, patient and system; however, there are overlaps between categories. Clinician behaviour is the most important of these. Exclusion of patients for reasons other than defined eligibility criteria, concerns about increased time requirements, and suboptimal communication with patients all affect accrual. Risk management strategies for clinical trials need to be individualised to address the obstacles most likely to negatively impact on accrual. Communication between clinician and patient appears to be a greater issue than previously recognised. Time concerns need to be addressed as generational change affects the expectations of the medical workforce.