The impact of coronavirus disease 2019 on genitourinary and prostate cancer care and clinical trials: a qualitative exploration of the Australian and New Zealand experience.

Abstract: Purpose: This qualitative study aimed to understand the impact of the coronavirus disease 2019 pandemic from March to November 2020 on healthcare delivery and clinical trials for genitourinary (GU) cancers in Australia. Methods: Annually a pre‐conference workshop is hosted by the Australian New Zealand Urogenital and Prostate Cancer Trials Group for supportive care health professionals. In November 2020, those that selected to attend were invited to participate in a focus group. Workshop and focus group discussions were recorded and transcripts were analyzed thematically. Results: Seventy‐two individuals involved in GU cancer care and clinical trials took part. Participants described negative changes to GU cancer care and clinical trials from the pandemic due to reduced clinical services and increased wait times. Trial recruitment was paused temporarily during lockdowns, and standard treatment protocols were used to limit hospital visits. Trial process changes included electronic capture of informed consent, home delivery of oral medications, and delegations of assessments. These changes increased administrative activity for clinical trial teams and Human Research Ethics Committees. A transition to telehealth enabled continuity of service delivery and trials but reduced the opportunity for face‐to‐face patient consultations with increasing concern about the failure to detect supportive care needs. Conclusion: The pandemic has prompted a critical review of service delivery and clinical trials for people with GU cancers

Psychological support for patients with cancer: evidence review and suggestions for future directions

This is a non-final version of an article published in final form in Hulbert-Williams, N. J., Beatty, L., & Dhillon. H. (2018). Psychological support for patients with cancer: evidence review and suggestions for future research. Current Opinion in Supportive & Palliative Care, 12(3), 276-292.Purpose of the review. Psychological distress and mental health comorbidity are common in cancer. Various therapeutic frameworks have been used for interventions to improve psychological wellbeing and quality of life in cancer patients with mixed results. This paper reviews contributions to that literature published since January 2017. Recent findings. The majority of new psychological intervention research in cancer has used Cognitive Behavioural Therapy or Mindfulness-Based Interventions. Cognitive behavioural Therapy has been considered a gold-standard intervention and recent evidence justifies continuation of this. Recent reviews call into question the validity of evidence for Mindfulness- Based Interventions. A smaller number of trials using Acceptance and Commitment Therapy, Meta-Cognitive Therapy, Dignity Therapy and Coaching have emerged, and whilst findings are promising, additional fully-powered trials are required. Weaker evidence exists for counselling, support-based, and Narrative Therapy interventions. Summary. Efficacious, timely and acceptable psychological interventions are a necessary component of comprehensive cancer care. There is some way to go before the evidence conclusively points towards which interventions work for which cancer groups and for which specific outcomes. Methodological limitations must be addressed in future trials; at the forefront remains the need for fully-powered, head-to-head comparison trials

Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Objectives: Qualitative studies nested within clinical trials can provide insight into the treatment experience, how this evolves over time and where improved supportive care is required. The purpose of this qualitative study is to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial; a randomised trial of 177Lu-PSMA-617 compared with cabazitaxel chemotherapy. Methods: Fifteen men with advanced prostate cancer were recruited from the TheraP clinical trial with interviews conducted at three timepoints during the trial. An interpretative phenomenological approach was used, and interviews analysed using thematic analysis. This research paper reports the results from the mid-point, conclusion and follow up interviews, focusing specifically on participants\u27 experiences of trial participation. Results: Three themes were identified representing the lived experiences of men with advanced prostate cancer participating in the TheraP trial: (1) facing limited options; (2) anticipating outcomes and (3) coping with health changes. Conclusions: Men who enrol in clinical trial of anti-neoplastic treatments for prostate cancer need targeted psychological and supportive care that includes attention to unique aspects of the experience of having prostate cancer and being in a clinical trial. As part of their trial experience, men with advanced prostate cancer need to be regularly assessed for survivorship needs, fully informed, supported and referred to services for regular care and support across the trajectory of their disease. Trial registration: NCT03392428. Registered on 8 January 2018 (ANZUP1603)

Setting an International Research Agenda for Fear of Cancer Recurrence: an online delphi consensus study

This Document is Protected by copyright and was first published by Frontiers. All rights reserved. it is reproduced with permissionBackground: Fear of cancer recurrence (FCR) is common amongst cancer survivors. There is rapidly growing research interest in FCR but a need to prioritise research to address the most pressing clinical issues and reduce duplication and fragmentation of effort. This study aimed to establish international consensus among clinical and academic FCR experts regarding priorities for FCR research. Methods: Members of the International Psycho-oncology Society (IPOS) Fear of Cancer Recurrence Special Interest Group (FORwards) were invited to participate in an online Delphi study. Research domains identified in Round 1 were presented and discussed at a focus group (Round 2) to consolidate the domains and items prior to presentation in further survey rounds (Round 3) aimed at gaining consensus on research priorities of international significance. Results: Thirty four research items were identified in Round 1 and 33 of the items were consolidated into 6 overarching themes through a focus group discussion with FCR experts. The 33 research items were presented in subsequent rounds of the delphi technique. Twenty one participants contributed to delphi round 1, 16 in round 2 and 25 and 29 participants for subsequent delphi rounds. Consensus was reached for 27 items in round 3.1. A further 4 research items were identified by panellists and included in round 3.2. After round 3.2, 35 individual research items were ratified by the panellists. Given the high levels of consensus and stability between rounds no further rounds were conducted. Overall intervention research was considered the most important focus for FCR research. Panellists identified models of care that facilitate greater access to FCR treatment and evaluation of the effectiveness of FCR interventions in real world settings as the two research items of highest priority. Defining the mechanisms of action and active components across FCR/P interventions, was the third highest priority identified. Conclusions: The findings of this study outline a research agenda for international FCR research. Intervention research to identify models of care that increase access to treatment, are based on a flexible approach based on symptom severity and can be delivered within routine clinical care, were identified as research areas to prioritise. Greater understanding of the active components and mechanisms of action of existing FCR interventions will facilitate increased tailoring of interventions to meet patient need

Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Objectives: Qualitative studies nested within clinical trials can provide insight into the treatment experience, how this evolves over time and where improved supportive care is required. The purpose of this qualitative study is to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial; a randomised trial of 177Lu-PSMA-617 compared with cabazitaxel chemotherapy. Methods: Fifteen men with advanced prostate cancer were recruited from the TheraP clinical trial with interviews conducted at three timepoints during the trial. An interpretative phenomenological approach was used, and interviews analysed using thematic analysis. This research paper reports the results from the mid-point, conclusion and follow up interviews, focusing specifically on participants’ experiences of trial participation. Results: Three themes were identified representing the lived experiences of men with advanced prostate cancer participating in the TheraP trial: (1) facing limited options; (2) anticipating outcomes and (3) coping with health changes. Conclusions: Men who enrol in clinical trial of anti-neoplastic treatments for prostate cancer need targeted psychological and supportive care that includes attention to unique aspects of the experience of having prostate cancer and being in a clinical trial. As part of their trial experience, men with advanced prostate cancer need to be regularly assessed for survivorship needs, fully informed, supported and referred to services for regular care and support across the trajectory of their disease

Evaluation of a Web-Based Cognitive Rehabilitation Program in Cancer Survivors Reporting Cognitive Symptoms After Chemotherapy

Purpose: Cognitive impairment is reported frequently by cancer survivors. There are no proven treatments. We evaluated a cognitive rehabilitation program (Insight) and compared it with standard care in cancer survivors self-reporting cognitive symptoms. Patients and Methods: We recruited adult cancer survivors with a primary malignancy (excluding central nervous system malignancies) who had completed three or more cycles of adjuvant chemotherapy in the previous 6 to 60 months and reported persistent cognitive symptoms. All participants received a 30-minute telephone consultation and were then randomly assigned to the 15-week, home-based intervention or to standard care. Primary outcome was self-reported cognitive function (Functional Assessment of Cancer Therapy Cognitive Function [FACT-COG] perceived cognitive impairment [PCI] subscale): difference between groups after intervention (T2) and 6 months later (T3). Results: A total of 242 participants were randomly assigned: median age, 53 years; 95% female. The primary outcome of difference in FACT-COG PCI was significant, with less PCI in the intervention group at T2 (P < .001). This difference was sustained at T3 (P < .001). At T2, there was a significant difference in all FACT-COG subscales, favoring the intervention. Neuropsychological results were not significantly different between the groups at T2 or T3. There were significantly lower levels of anxiety/depression and fatigue in the intervention group at T2. There were significant improvements in stress in the intervention group at both time points. There was no significant difference in quality of life between the groups at T2, but the intervention group had better quality of life at T3. Conclusion: The intervention, Insight, led to improvements in cognitive symptoms compared with standard care. To our knowledge, this is the first large randomized controlled trial showing an improvement in self-reported cognitive function in cancer survivors, indicating that this intervention is a feasible treatment.Supported by the Cancer Council New South Wales, Friends of the Mater Foundation, a Cancer Institute New South Wales Clinical Fellowship (V.J.B.), a Clinical Oncology Society of Australia/Roche Hematology Oncology Targeted Therapies Fellowship (V.J.B.), a Pfizer Cancer Research Grant (V.J.B.), and by the National Breast Cancer Foundation (J.L.V.)

Investigation of herb-drug interactions with ginkgo biloba in women receiving hormonal treatment for early breast cancer

Women receiving treatment for breast cancer commonly ingest herbal medicines. Little is known about the potential for herb-drug interactions in this population. The aim of this study is to investigate the effect of ginkgo biloba co-administration on the pharmacokinetics of tamoxifen, anastrozole and letrozole. This was a prospective open-label cross-over study in 60 women with early stage breast cancer taking either tamoxifen, anastrozole or letrozole (n=20/group). Participants received ginkgo biloba (EGb 761) for 3 weeks (120 mg twice daily). Trough concentrations of drugs were measured before and after ginkgo biloba treatment using LC-MS/MS. Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events. Trough concentrations before and after treatment with ginkgo biloba were not significantly different for tamoxifen (93.5 ± 29.0, 86.5 ± 25.3 ng/mL; p=0.16), letrozole (91.1 ± 50.4, 89.6 ± 52.14 ng/mL; p=0.60) or anastrozole (29.1 ± 8.6, 29.1 ± 7.6 ng/mL; p=0.97). Ginkgo biloba was well tolerated, with no difference in toxicity during ginkgo biloba. Co-administration of ginkgo biloba does not significantly affect the pharmacokinetics of tamoxifen, anastrozole or letrozole. There was no difference in the toxicity profile of hormone therapy with ginkgo biloba use in women with early stage breast cancer

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan

Background: The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness. Objective: The objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis. Methods: The SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data. Results: The resulting SAP is consistent with best practice and will allow open and transparent reporting. Conclusion: We have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias

Whole brain radiotherapy after local treatment of brain metastases in melanoma patients - a randomised phase III trial

<p>Abstract</p> <p>Background</p> <p>Cerebral metastases are a common cause of death in patients with melanoma. Systemic drug treatment of these metastases is rarely effective, and where possible surgical resection and/or stereotactic radiosurgery (SRS) are the preferred treatment options. Treatment with adjuvant whole brain radiotherapy (WBRT) following neurosurgery and/or SRS is controversial. Proponents of WBRT report prolongation of intracranial control with reduced neurological events and better palliation. Opponents state melanoma is radioresistant; that WBRT yields no survival benefit and may impair neurocognitive function. These opinions are based largely on studies in other tumour types in which assessment of neurocognitive function has been incomplete.</p> <p>Methods/Design</p> <p>This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial comparing WBRT to observation following local treatment of intracranial melanoma metastases with surgery and/or SRS. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an ECOG status of 0-2 are eligible. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for brain metastases are ineligible. WBRT prescription is at least 30 Gy in 10 fractions commenced within 8 weeks of surgery and/or SRS. Randomisation is stratified by the number of cerebral metastases, presence or absence of extracranial disease, treatment centre, sex, radiotherapy dose and patient age. The primary endpoint is the proportion of patients with distant intracranial failure as determined by MRI assessment at 12 months. Secondary end points include: survival, quality of life, performance status and neurocognitive function.</p> <p>Discussion</p> <p>Accrual to previous trials for patients with brain metastases has been difficult, mainly due to referral bias for or against WBRT. This trial should provide the evidence that is currently lacking in treatment decision-making for patients with melanoma brain metastases. The trial is conducted by the Australia and New Zealand Melanoma Trials Group (ANZMTG-study 01-07), and the Trans Tasman Radiation Oncology Group (TROG) but international participation is encouraged. Twelve sites are open to date with 43 patients randomised as of the 31st March 2011. The target accrual is 200 patients.</p> <p>Trial registration</p> <p>Australia and New Zealand Clinical Trials Register (ANZCTR): <a href="http://www.anzctr.org.au/ACTRN12607000512426.aspx">ACTRN12607000512426</a></p