Evaluation of Managing Cancer and Living Meaningfully (CALM) in people with advanced non-small cell lung cancer treated with immunotherapies or targeted therapies: protocol for a single-arm, mixed-methods pilot study.

INTRODUCTION: People with advanced non-small cell lung cancer (NSCLC) treated with immunotherapies (IT) or targeted therapies (TT) may have improved outcomes in a subset of people who respond, raising unique psychological concerns requiring specific attention. These include the need for people with prolonged survival to reframe their life plans and tolerate uncertainty related to treatment duration and prognosis. A brief intervention for people with advanced cancer, Managing Cancer and Living Meaningfully (CALM), could help people treated with IT or TT address these concerns. However, CALM has not been specifically evaluated in this population. This study aims to evaluate the acceptability and feasibility of CALM in people with advanced NSCLC treated with IT or TT and obtain preliminary evidence regarding its effectiveness in this population. METHODS AND ANALYSIS: Twenty people with advanced NSCLC treated with IT or TT will be recruited from Peter MacCallum Cancer Centre, Melbourne, Australia. Participants will complete three to six sessions of CALM delivered over 3-6 months. A prospective, single-arm, mixed-methods pilot study will be conducted. Participants will complete outcome measures at baseline, post-intervention, 3 months and 6 months, including Patient Health Questionnaire, Death and Dying Distress Scale, Functional Assessment of Cancer Therapy General and Clinician Evaluation Questionnaire. The acceptability of CALM will be assessed using patient experiences surveys and qualitative interviews. Feasibility will be assessed by analysis of recruitment rates, treatment adherence and intervention delivery time. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/82047/PMCC). Participants with cancer will complete a signed consent form prior to participation, and carers and therapists will complete verbal consent. Results will be made available to funders, broader clinicians and researchers through conference presentations and publications. If CALM is found to be acceptable in this cohort, this will inform a potential phase 3 trial.

Patterns of care for people with small cell lung cancer in Victoria, 2011-19: a retrospective, population-based registry data study.

OBJECTIVES: To report stage-specific patterns of treatment and the influence of management and treatment type on survival rates for people newly diagnosed with small cell lung cancer (SCLC). DESIGN: Cross-sectional patterns of care study; analysis of data prospectively collected for the Victorian Lung Cancer Registry (VLCR). SETTING, PARTICIPANTS: All people diagnosed with SCLC in Victoria during 1 April 2011 - 18 December 2019. MAIN OUTCOME MEASURES: Stage-specific management and treatment of people with SCLC; median survival time. RESULTS: During 2011-19, 1006 people were diagnosed with SCLC (10.5% of all lung cancer diagnoses in Victoria); their median age was 69 years (interquartile range [IQR], 62-77 years), 429 were women (43%), and 921 were current or former smokers (92%). Clinical stage was defined for 896 people (89%; TNM stages I-III, 268 [30%]; TNM stage IV, 628 [70%]) and ECOG performance status at diagnosis for 663 (66%; 0 or 1, 489 [49%]; 2-4, 174 [17%]). The cases of 552 patients had been discussed at multidisciplinary meetings (55%), 377 people had received supportive care screening (37%), and 388 had been referred for palliative care (39%). Active treatment was received by 891 people (89%): chemotherapy, 843 (84%); radiotherapy, 460 (46%); chemotherapy and radiotherapy, 419 (42%); surgery, 23 (2%). Treatment had commenced within fourteen days of diagnosis for 632 of 875 patients (72%). Overall median survival time from diagnosis was 8.9 months (IQR, 4.2-16 months; stage I-III: 16.3 [IQR, 9.3-30] months; stage IV: 7.2 [IQR, 3.3-12] months). Multidisciplinary meeting presentation (hazard ratio [HR], 0.66; 95% CI, 0.58-0.77), multimodality treatment (HR, 0.42; 95% CI, 0.36-0.49), and chemotherapy within fourteen days of diagnosis (HR, 0.68; 95% CI, 0.48-0.94) were each associated with lower mortality during follow-up. CONCLUSION: Rates of supportive care screening, multidisciplinary meeting evaluation, and palliative care referral for people with SCLC could be improved. A national registry of SCLC-specific management and outcomes data could improve the quality and safety of care.

Development of an Australia and New Zealand Lung Cancer Clinical Quality Registry: a protocol paper.

INTRODUCTION: Lung cancer is the leading cause of cancer mortality, comprising the largest national cancer disease burden in Australia and New Zealand. Regional reports identify substantial evidence-practice gaps, unwarranted variation from best practice, and variation in processes and outcomes of care between treating centres. The Australia and New Zealand Lung Cancer Registry (ANZLCR) will be developed as a Clinical Quality Registry to monitor the safety, quality and effectiveness of lung cancer care in Australia and New Zealand. METHODS AND ANALYSIS: Patient participants will include all adults >18 years of age with a new diagnosis of non-small-cell lung cancer (NSCLC), SCLC, thymoma or mesothelioma. The ANZLCR will register confirmed diagnoses using opt-out consent. Data will address key patient, disease, management processes and outcomes reported as clinical quality indicators. Electronic data collection facilitated by local data collectors and local, state and federal data linkage will enhance completeness and accuracy. Data will be stored and maintained in a secure web-based data platform overseen by registry management. Central governance with binational representation from consumers, patients and carers, governance, administration, health department, health policy bodies, university research and healthcare workers will provide project oversight. ETHICS AND DISSEMINATION: The ANZLCR has received national ethics approval under the National Mutual Acceptance scheme. Data will be routinely reported to participating sites describing performance against measures of agreed best practice and nationally to stakeholders including federal, state and territory departments of health. Local, regional and (bi)national benchmarks, augmented with online dashboard indicator reporting will enable local targeting of quality improvement efforts.

Patient and Clinician Preferences for Genetic and Genomic Testing in Non-Small Cell Lung Cancer: A Discrete Choice Experiment.

Precision (personalised) medicine for non-small cell lung cancer (NSCLC) adopts a molecularly guided approach. Standard-of-care testing in Australia is via sequential single-gene testing which is inefficient and leads to tissue exhaustion. The purpose of this study was to understand preferences around genetic and genomic testing in locally advanced or metastatic NSCLC. A discrete choice experiment (DCE) was conducted in patients with NSCLC (n = 45) and physicians (n = 44). Attributes for the DCE were developed based on qualitative interviews, literature reviews and expert opinion. DCE data were modelled using a mixed multinomial logit model (MMNL). The results showed that the most important attribute for patients and clinicians was the likelihood of an actionable test, followed by the cost. Patients significantly preferred tests with a possibility for reporting on germline findings over those without (ß = 0.4626) and those that required no further procedures over tests that required re-biopsy (ß = 0.5523). Physician preferences were similar (ß = 0.2758 and ß = 0.857, respectively). Overall, there was a strong preference for genomic tests that have attribute profiles reflective of comprehensive genomic profiling (CGP) and whole exome sequencing (WES)/whole genome sequencing (WGS), irrespective of high costs. Participants preferred tests that provided actionable outcomes, were affordable, timely, and negated the need for additional biopsy.

A systematic review of economic evaluations of preoperative smoking cessation for preventing surgical complications.

BACKGROUND: Whilst there is a substantial body of evidence on the costs and benefits of smoking cessation generally, the benefits of routinely providing smoking cessation for surgical populations are less well known. This review summarises the evidence on the cost-effectiveness of preoperative smoking cessation to prevent surgical complications. MATERIALS AND METHODS: A search of the Cochrane, Econlit, EMBASE, Health Technology Assessment, Medline Complete and Scopus databases was conducted from inception until June 23, 2021. Peer-reviewed, English-language articles describing economic evaluations of preoperative smoking cessation interventions to prevent surgical complications were included. Search results were independently screened for potentially eligible studies. Study characteristics, economic evaluation methods and cost-effectiveness results were extracted by one reviewer and details checked by a second. Two authors independently assessed reporting and methodological quality using the Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies Instrument checklist (QHES) respectively. RESULTS: After removing duplicates, twenty full text articles were screened from 1423 database records, resulting in six included economic evaluations. Studies from the United States (n = 4), France (n = 1) and Spain (n = 1) were reported between 2009 and 2020. Four evaluations were conducted from a payer perspective. Two-thirds of evaluations were well-conducted (mean score 83) and well-reported (on average, 86% items reported). All studies concluded preoperative smoking cessation is cost-effective for preventing surgical complications; results ranged from cost saving to €53,131 per quality adjusted life year gained. CONCLUSIONS: Preoperative smoking cessation is cost-effective for preventing surgical complications from a payer or provider perspective when compared to standard care. There is no evidence from outside the United States and Europe to inform healthcare providers, funders and policy-makers in other jurisdictions and more information is needed to clarify the optimal point of implementation to maximise cost-effectiveness of preoperative smoking cessation intervention. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2021 CRD42021257740. RESEARCH REGISTRY REGISTRATION NUMBER: reviewregistry1369.

Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy.

PURPOSE: Immunotherapy (IT) and targeted therapy (TT) have improved survival for some patients with metastatic non-small cell lung cancer (NSCLC). Their lived experience is under-studied. We conducted a single centre, qualitative study to understand concerns and unmet needs amongst this novel survivor population. METHODS: Eligible participants had metastatic NSCLC, aged >18, English-speaking and >6 months post initiation of IT/TT without progressive disease. Semi-structured interviews focused on physical, psychological, social and functional impacts of diagnosis, therapy and prognosis. Interviews were recorded and transcribed. Data were analysed via qualitative thematic analysis. RESULTS: Between May and December 2019, 20 participants were interviewed: median age 62 (range 34-83), 13 (65%) female; median time since diagnosis of metastatic NSCLC 27 months (range 10-108). Twelve out of 20 (60%) participants had a targetable mutation (EGFR/ALK/BRAF); 6 were receiving IT, 11 TT, 2 IT + chemotherapy and 1 IT + TT. Four main themes were identified: living long-term on IT and TT (chronic toxicities), psychological concerns (living with uncertainty, fear of cancer progression, scan-related anxiety), support with practical issues (finances, employment amidst prognostic uncertainty, challenges with trial participation) and wanting information pertinent to NSCLC subtype. CONCLUSIONS: Longer-term survivors of metastatic NSCLC experience significant physical, psychological and functional concerns and unmet needs. Results will inform a broader cross-sectional survey and resources to address the needs of this growing survivor group. IMPLICATIONS FOR CANCER SURVIVORS: A 'one-size-fits-all' approach to NSCLC survivorship is no longer appropriate. Survivors of metastatic NSCLC treated with novel therapies may benefit from specific information regarding long-term toxicities and psychological supports.

Ultrasound changes after rotator cuff repair: is supraspinatus tendon thickness related to pain?

BACKGROUND: Little is known about the morphology of healing rotator cuffs after surgical repair. This investigation aimed to determine whether there are changes in tendon thickness, subacromial bursa, anatomical footprint, tendon vascularity, and capsular thickness after rotator cuff repair, and whether supraspinatus tendon thickness correlates with pain. METHODS: Fifty-seven patients completed a validated pain questionnaire. Using a standardized protocol, their shoulders were scanned by the same ultrasonographer at 1 week, 6 weeks, 3 months, and 6 months postarthroscopic repair by a single surgeon. The contralateral shoulders, if uninjured, were also scanned. RESULTS: Of 57 patients, 4 re-tore their tendons at 6 weeks and 4 retore at 3 months. Sixteen of the remaining 49 patients had intact contralateral supraspinatus tendons. The repaired supraspinatus tendon thickness remained unchanged throughout the 6 months. Compared to week 1, at 6 months, bursal thickness decreased from 1.9 (0.7) mm to 0.7 (0.5) mm (P < .001); anatomical footprint increased from 7.0 (2.0) mm to 9.3 (1.5) mm; tendon vascularity decreased from mild to none (P < .001); posterior capsule thickness decreased from 2.3 (0.8) mm to 1.3 (0.6) mm (P < .001). Frequency and severity of pain and shoulder stiffness decreased (P < .001). There was no correlation between tendon thickness and pain. CONCLUSION: After rotator cuff repair, there was an immediate increase in subacromial bursa thickness, tendon vascularity, and posterior glenohumeral capsular thickness. These normalized after 6 months. Tendon thickness was unchanged while footprint contact was comparable with the contralateral tendons. There was no correlation between tendon thickness and pain.

Intraoperative determinants of rotator cuff repair integrity: an analysis of 500 consecutive repairs.

BACKGROUND: Rotator cuff repair has a relatively high (20%-90%) chance of retears. Patients with an intact rotator cuff 6 months after surgery have better subjective and objective outcomes at 6 months and 2 years after rotator cuff repair than those who do not have an intact repair. PURPOSE: The aim of this study was to determine if, and if so which, intraoperative factors predict an intact repair 6 months after rotator cuff repair. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: The study consisted of a cohort of 500 consecutive patients who had an arthroscopic rotator cuff repair performed by a single surgeon and an ultrasound evaluation using standard protocols of the repair 6 months after surgery. Exclusion criteria included previous fracture or shoulder surgery, incomplete or partial rotator cuff repair, and concomitant arthroplasty. Rotator cuff tear size was measured intraoperatively and mapped. The quality of the tendon, tendon mobility, and repair quality were assessed and ranked based on predetermined scales (1-4) and recorded on a specifically designed form. Logistic regression analysis was performed, with cuff integrity at 6-month follow-up as the dependent variable and tear/repair factors as the independent variables. RESULTS: The overall postoperative retear rate was 19% at 6 months. The best predictor of rotator cuff integrity was preoperative tear size (correlation coefficient, r = 0.33; P < .001). Patients with small (≤2 cm(2)) rotator cuff tears were least likely to have retears (retear rate, 10%). As the tear size increased, the retear rate increased in a linear fashion: ≤2 cm(2) (10%), 2 to 4 cm(2) (16%), 4 to 6 cm(2) (31%), 6 to 8 cm(2) (50%), and >8 cm(2) (57%). Other surgeon-ranked intraoperative assessments did correlate with retears, but the correlations were relatively weak: repair quality (r = -0.17; P < .001), tendon mobility (r = -0.15; P < .001), and tendon quality (r = -0.14; P < .01). Regression analysis showed that the retear rate at 6-month follow-up was best predicted from the preoperative tear size and the surgeon-ranked repair quality: chance of retear = 0.38 + (0.02 × tear size in cm(2)) - (0.08 × repair quality). Tendon quality and tendon mobility did not contribute significantly to this prediction. CONCLUSION: Tear size was the best intraoperative predictor of repair integrity after rotator cuff repair, with tears less than 2 cm(2) twice as likely to heal than tears greater than 6 cm(2).

A comparison of outcomes after arthroscopic repair of partial versus small or medium-sized full-thickness rotator cuff tears.

BACKGROUND: Little is known about the outcomes after repair of partial-thickness rotator cuff tears. The aim of this study was to assess the outcome after repair of partial-thickness rotator cuff tears compared with full-thickness tears. Our hypothesis was that repair of partial-thickness tears leads to more shoulder stiffness but fewer retears compared with repair of full-thickness tears. METHODS: A group of 105 consecutive patients who had a full-thickness tear measuring <3 cm2 was compared with a group of sixty-four patients who had a partial-thickness tear. All tears were repaired with use of a knotless single-row arthroscopic repair. The American Shoulder and Elbow Surgeons (ASES) score and standardized patient and examiner-determined outcomes were obtained preoperatively and at six, twelve, and twenty-four weeks and at two years after surgery. Rotator cuff integrity was determined by ultrasound examination at six months and two years after surgery. RESULTS: Examiner-determined postoperative stiffness at six weeks was common in both groups (50% of those with a partial-thickness tear and 47% of those with a full-thickness tear) but was decreased compared with preoperative findings in both groups to 21% and 19%, respectively, at three months and to 15% and 14% at six months. The ultrasound-determined retear rate was small (5% in the partial-thickness group and 10% in the full-thickness group) at six months, but increased to 10% and 20%, respectively, at twenty-four months. The ASES score, patient-determined overall shoulder function, and all pain scores were superior to preoperative scores at six months (p < 0.001) and at twenty-four months (p < 0.001) in both groups. CONCLUSIONS: Arthroscopic repair of partial-thickness and small and medium-sized full-thickness rotator cuff tears was associated with excellent medium-term clinical outcomes with low retear rates. The data did not support our hypothesis: the differences in retear rate and postoperative shoulder stiffness rate found between the two groups did not reach significance.