Efficacy of aerobic and resistance exercises on cancer pain: A meta-analysis of randomised controlled trials.

Purpose: To evaluate effects of aerobic and resistance exercises for cancer-related pain in adults with and surviving cancer. Secondary objectives were to a) evaluate the effect of exercise on fatigue, psychological function, physical function, b) assess fidelity to exercise. Design: A systematic search of MEDLINE, EMBASE, AMED, CINAHL and Cochrane Central Register of Controlled Trials was conducted to identify randomised controlled trials (RCTs) comparing aerobic and/or resistance exercise to control groups. The primary endpoint were changes in cancer-related pain intensity from baseline to post intervention. Meta-regression analysis evaluated predictors for heterogeneity between study findings. Tolerability was defined as reporting of exercise-induced adverse events while fidelity evaluated by reported intervention dropout. Results: Twenty-three RCTs including 1954 patients (age 58 ± 8.5 years; 78 % women); 1087 (56 %) and 867 (44 %) allocated to aerobic/resistance exercise therapy and control group, respectively. Exercise therapy was associated with small to moderate decreases in cancer-related pain compared to controls (SMD = 0.38, 95 % CI: 0.17, 0.58). Although there was significant heterogeneity between individual and pooled study effects (Q = 205.25, p < 0.0001), there was no publication bias. Meta-regression including supervision, age, duration and exercise type as moderators showed no significant differences in reported outcomes. Analysis of secondary outcomes revealed a moderate effect for improvements in physical function, fatigue and psychological symptoms. Conclusions: Aerobic and resistance exercises are tolerable and effective adjunct therapies to reduce cancer-related pain while also improving physical function, fatigue and mood. Future RCTs of dose, frequency, compliance and exercise type in specific cancer settings are required.

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology.

OBJECTIVE: Informal family caregivers play a crucial role in cancer care. Effective caregiver involvement in cancer care can improve both patient and caregiver outcomes. Despite this, interventions improving the caregiver involvement are sparse. This protocol describes a randomised controlled trial evaluating the combined effectiveness of novel online caregiver communication education modules for: (1) oncology clinicians (eTRIO) and (2) patients with cancer and caregivers (eTRIO-pc). METHODS AND ANALYSIS: Thirty medical/radiation/surgical oncology or haematology doctors and nurses will be randomly allocated to either intervention (eTRIO) or control (an Australian State Government Health website on caregivers) education conditions. Following completion of education, each clinician will recruit nine patient-caregiver pairs, who will be allocated to the same condition as their recruiting clinician. Eligibility includes any new adult patient diagnosed with any type/stage cancer attending consultations with a caregiver. Approximately 270 patient-caregiver pairs will be recruited. The primary outcome is caregiver self-efficacy in triadic (clinician-patient-caregiver) communication. Patient and clinician self-efficacy in triadic communication are secondary outcomes. Additional secondary outcomes for clinicians include preferences for caregiver involvement, perceived module usability/acceptability, analysis of module use, satisfaction with the module, knowledge of strategies and feedback interviews. Secondary outcomes for caregivers and patients include preferences for caregiver involvement, satisfaction with clinician communication, distress, quality of life, healthcare expenditure, perceived module usability/acceptability and analysis of module use. A subset of patients and caregivers will complete feedback interviews. Secondary outcomes for caregivers include preparedness for caregiving, patient-caregiver communication and caring experience. Assessments will be conducted at baseline, and 1 week, 12 weeks and 26 weeks post-intervention. ETHICS AND DISSEMINATION: Ethical approval has been received by the Sydney Local Health District Human Research Ethics Committee (REGIS project ID number: 2019/PID09787), with site-specific approval from each recruitment site. Protocol V.7 (dated 1 September 2020) is currently approved and reported in this manuscript. Findings will be disseminated via presentations and peer-reviewed publications. Engagement with clinicians, media, government, consumers and peak cancer groups will facilitate widespread dissemination and long-term availability of the educational modules. TRIAL REGISTRATION NUMBER: ACTRN12619001507178.

Instruments that measure psychosocial factors related to vaccination: a scoping review protocol.

INTRODUCTION: As vaccine-preventable disease outbreaks increase, there is growing international interest in monitoring public attitudes towards vaccination and implementing and evaluating vaccine promotion interventions. Outcome selection and measurement are central to intervention evaluation. Measuring uptake rates alone cannot determine which elements in a multicomponent vaccine-promotion intervention are most effective, why specific populations are undervaccinated or when confidence in vaccines is wavering. To develop targeted and cost-effective interventions and policies, it is necessary to measure vaccination-related psychosocial factors such as knowledge, attitudes and aspects of decision-making. This scoping review aims to identify, compare and summarise the properties and validation of instruments for measuring vaccination-related psychosocial factors and identify gaps where no instruments exist. METHODS AND ANALYSIS: We will search Medline OVID, Embase OVID, CINAHL and PsycINFO with no date restriction, using a pilot-tested search strategy of terms related to vaccination: knowledge, attitudes, trust, acceptance and decision-making and measurement, psychometric testing or validation. This search will be supplemented with manual search and expert consultation. We will include studies that describe instrument development, adaptation or testing and include evaluation of at least two measurement properties (eg, content, criterion, or construct validity; test-retest reliability; internal consistency; sensitivity; responsiveness). Instruments measuring a vaccination-related psychosocial factor in any population will be included. All studies will be screened by one reviewer, with a sample double-screened to confirm accuracy. Disagreements will be resolved with a third reviewer. Data will be synthesised narratively and through summary tables to chart and compare instrument characteristics such as factors measured, date and/or location of development or validation, measurement properties evaluated and population. ETHICS AND DISSEMINATION: This scoping review aims to provide an overview of existing instruments and ascertain measurement gaps where no measurement instruments currently exist. The identified instruments will form the basis of an open-access online repository of instruments.

The EORTC Quality of Life Questionnaire for cancer patients (QLQ-C30): Australian general population reference values.

OBJECTIVES: To generate Australian general population reference values for the EORTC Quality of Life Questionnaire for cancer patients (QLQ-C30); to compare Australian values with published EORTC general population reference values, and to explore associations between socio-demographic and health characteristics and QLQ-C30 subscale scores. DESIGN: Analysis of responses to cross-sectional, online survey (QLQ-C30), March 2015 - February 2016, and supplementary health-related and socio-demographic questions. SETTING, PARTICIPANTS: 1979 people quota-sampled from a national online survey panel to be representative of the Australian general population by age and sex. MAIN OUTCOME MEASURES: Mean QLQ-C30 subscale scores, adjusted for socio-demographic characteristics and comorbid conditions, by sex and age group. RESULTS: Data for 1821 participants were analysed (92% completion rate); 924 (50.7%) were women. Higher psychological distress was associated with worse outcomes on all QLQ-C30 subscales. Better self-reported general health was associated with better global quality of life and better functioning (except cognitive functioning), and less fatigue, pain, dyspnoea and insomnia. Having arthritis or rheumatism was associated with poorer global quality of life, and poorer physical, role and social functioning, and with more fatigue, pain, insomnia, diarrhoea, and financial difficulties. Although differences between Australian QLQ-C30 subscale scores and EORTC general population values were clinically trivial, the Australian values are more accurate benchmarks for QLQ-C30 results from Australians with cancer. CONCLUSIONS: Our Australian QLQ-C30 reference values provide normative benchmarks that facilitate interpretation of data for Australians with cancer in terms of burden of disease and its treatment. In survivorship studies and studies without pre-disease baseline data, comparisons with reference values can indicate the extent to which people have returned to better levels of health.

Psychometric Evaluation of a Patient-Reported Symptom Index for Nonmuscle Invasive Bladder Cancer: Field Testing Protocol.

BACKGROUND: Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. OBJECTIVE: The overarching aim of this study was to develop and evaluate a patient-reported symptom index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to differences between contemporary treatments for NMIBC; and fit for purpose as an endpoint in clinical trials. METHODS: The NMIBC-SI will be evaluated in 2 field tests across a total of 3 years. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or those who completed final treatment within the past week. Data collected include patient demographics, clinical features of the tumor, risk category, treatment type, comorbidity, and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at 4 time points during treatment: before tumor resection, 1 week after resection, end-of-induction intravesical therapy, and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. RESULTS: Participant recruitment to field test 1 commenced in February 2017. Recruitment for field test 2 is planned to commence in January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. CONCLUSIONS: This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity, and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research and provides an evidence base for the ongoing improvement of future therapies for NMIBC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03091764; http://clinicaltrials.gov/ct2/showNCT03091764 (Archived by WebCite at http://www.webcitation.org/6umBhQeNX).

Barriers to radiotherapy utilisation in New South Wales Australia: Health professionals' perceptions of impacting factors.

INTRODUCTION: Utilisation of radiation therapy (RT) in Australia is below recommended evidence-based benchmarks. Barriers to the referral of patients for RT and the uptake of RT by patients may be affecting RT utilisation. The current study aimed to examine health professionals' (HPs) perceptions of potential barriers to RT referral and uptake. METHODS: A custom survey was developed to assess perceptions regarding the degree to which a range of issues affect decisions regarding RT. Hard copy surveys were disseminated to HPs involved in the care of cancer patients across New South Wales (NSW): medical, radiation and surgical oncologists, physicians (including palliative care), and general practitioners with an interest in oncology. Electronic versions of the survey were disseminated via oncology multidisciplinary teams and professional networks at participating hospitals. RESULTS: Two hundred fifty-three HPs participated via hard copy (n = 208) or electronic (n = 45) surveys. Two-thirds of HPs perceived acute side effects of RT, their management and impact on daily commitments, as well as fear and anxiety about RT, to exert moderate to significant influence on RT decisions. Treatment-related travel, need for accommodation and relocation were also perceived by 64% of HPs to do the same. Over half of HPs rated concern regarding late effects of RT, disruption to family and work life, and the ability to organise family and work commitments around RT, as moderate to significant influences on RT uptake. CONCLUSION: Perceptions of HPs in NSW reveal potential important influencers of RT decisions by patients and clinicians. An understanding of these additional issues and their actual impact on RT-related decisions may inform future interventions to improve RT access and utilisation.

Deriving a preference-based utility measure for cancer patients from the European Organisation for the Research and Treatment of Cancer's Quality of Life Questionnaire C30: a confirmatory versus exploratory approach.

BACKGROUND: Multi attribute utility instruments (MAUIs) are preference-based measures that comprise a health state classification system (HSCS) and a scoring algorithm that assigns a utility value to each health state in the HSCS. When developing a MAUI from a health-related quality of life (HRQOL) questionnaire, first a HSCS must be derived. This typically involves selecting a subset of domains and items because HRQOL questionnaires typically have too many items to be amendable to the valuation task required to develop the scoring algorithm for a MAUI. Currently, exploratory factor analysis (EFA) followed by Rasch analysis is recommended for deriving a MAUI from a HRQOL measure. AIM: To determine whether confirmatory factor analysis (CFA) is more appropriate and efficient than EFA to derive a HSCS from the European Organisation for the Research and Treatment of Cancer's core HRQOL questionnaire, Quality of Life Questionnaire (QLQ-C30), given its well-established domain structure. METHODS: QLQ-C30 (Version 3) data were collected from 356 patients receiving palliative radiotherapy for recurrent/metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter informed by the established QLQ-C30 structure and views of both patients and clinicians on which are the most relevant items. Dimensions determined by EFA or CFA were then subjected to Rasch analysis. RESULTS: CFA results generally supported the proposed QLQ-C30 structure (comparative fit index =0.99, Tucker-Lewis index =0.99, root mean square error of approximation =0.04). EFA revealed fewer factors and some items cross-loaded on multiple factors. Further assessment of dimensionality with Rasch analysis allowed better alignment of the EFA dimensions with those detected by CFA. CONCLUSION: CFA was more appropriate and efficient than EFA in producing clinically interpretable results for the HSCS for a proposed new cancer-specific MAUI. Our findings suggest that CFA should be recommended generally when deriving a preference-based measure from a HRQOL measure that has an established domain structure.