Nursing - Research Publications

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    Interventions to improve patient understanding of cancer clinical trial participation: a systematic review
    Kao, CY ; Aranda, S ; Krishnasamy, M ; Hamilton, B (WILEY, 2017-03)
    Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio-visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process.
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    Self-guided interventions for managing psychological distress in people with cancer - A systematic review
    Ugalde, A ; Haynes, K ; Boltong, A ; White, V ; Krishnasamy, M ; Schofield, P ; Aranda, S ; Livingston, P (ELSEVIER IRELAND LTD, 2017-05)
    OBJECTIVE: People with cancer can experience psychological distress but do not always desire, or engage with, professional support to assist with managing distress. Interventions that are self-directed or guided by patients may hold promise as they allow patients to engage with interventions as they need. The objective of this review is to describe and appraise the evidence for effectiveness of self-guided interventions that aim to manage psychological distress in people with cancer. METHODS: A systematic search of Medline, PsychInfo and CINAHL identified 15 relevant papers, reporting on 14 studies. RESULTS: Of the interventions, three studies comprised hard-copy workbooks, six studies used resource packs, four were online resources and one was a brief multimedia resource. One study was adequately powered and demonstrated a positive effect. Almost all interventions required some level of facilitation. Distressed participants may benefit more from interventions. CONCLUSION: Self-guided interventions represent a potentially efficient way of delivering support for people affected by cancer, however evidence supporting them is lacking. PRACTICE IMPLICATIONS: There is a need to generate evidence to understand the impact of self-guided interventions for: i) the ideal delivery point in the disease trajectory, ii) patient groups, iii) intervention content and iv) type and mode of delivery.
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    Identifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study
    Kao, C-Y ; Aranda, S ; Krishnasamy, M ; Hamilton, B (WILEY, 2018-11)
    PURPOSES: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. DESIGN AND METHODS: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff. FINDINGS: Of 156 eligible participants, 101 participants (64.7%) completed all three rounds. In round 1, 994 information items were reported and generated into 74 statements. These were grouped under eight headings essential to the informed consent process. In rounds 2 and 3, the list was reduced to 15 statements representing consensus on essential information to be included in a summarised patient information document to support decision-making regarding trial participation. Risks and discomforts, participation requirements and trial governance were identified as important considerations. CONCLUSIONS: The 15 essential statements identified in this study could be used as components of a summarised information sheet given to potential cancer clinical trial participants, as an adjunct to the informed consent process. A robust evaluation of the impact of these statements on the quality of the informed consent process is needed.
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    Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial
    Jefford, M ; Aranda, S ; Gough, K ; Lotfi-Jam, K ; Butow, P ; Krishnasamy, M ; Young, J ; Phipps-Nelson, J ; Russell, L ; King, D ; Schofield, P (BMC, 2013-08-19)
    BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful. METHODS/DESIGN: This study is a multisite, randomised controlled trial, designed to assess the impact of the addition of the SurvivorCare intervention to usual post-treatment care, for people with potentially cured CRC. SurvivorCare comprises the provision of survivorship educational materials, a tailored survivorship care plan, an individually tailored nurse-led, face-to-face end of treatment consultation and three subsequent telephone calls. Eligible patients have completed treatment for potentially cured CRC. Other eligibility criteria include stage I to III disease, age greater than 18 years and adequate understanding of English. All consenting patients complete questionnaires at three time points over a six-month period (baseline, two and six months). Measures assess psychological distress, unmet needs and quality of life. DISCUSSION: This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12610000207011.
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    A systematic review of cancer caregiver interventions: Appraising the potential for implementation of evidence into practice
    Ugalde, A ; Gaskin, CJ ; Rankin, NM ; Schofield, P ; Boltong, A ; Aranda, S ; Chambers, S ; Krishnasamy, M ; Livingston, PM (WILEY, 2019-04)
    OBJECTIVE: nformal caregivers provide substantial support for people living with cancer. Previous systematic reviews report on the efficacy of cancer caregiver interventions but not their potential to be implemented. The aim of this systematic review was to explore the potential for cancer caregiver interventions to be implemented into practice. METHODS: We searched three electronic databases to identify cancer caregiver interventions on 5 January 2018. We operationalised six implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and costs) into a tool to guide data extraction. RESULTS: The search yielded 33 papers (27 papers from electronic databases and six papers from other sources) reporting on 26 studies that met review criteria. Fewer than half the studies (46%) contained evidence about the acceptability of interventions from caregivers' perspectives; only two studies (8%) included interventions developed with input from caregivers. Two studies (8%) addressed potential adoption of interventions, and no studies discussed intentions, agreement, or action to implement interventions into practice. All studies reported on intervention appropriateness by providing a rationale for the interventions. For feasibility, on average less than one-third of caregivers who were eligible to be involved consented to participate. On fidelity, whether interventions were conducted as intended was reported in 62% of studies. Cost data were reported in terms of intervention delivery, requiring a median time commitment of staff of 180 minutes to be delivered. CONCLUSIONS: Caregiver intervention studies lack components of study design and reporting that could bridge the gap between research and practice. There is enormous potential for improvements in cancer caregiver intervention study design to plan for future implementation.
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    Identifying priorities for cancer caregiver interventions: protocol for a three-round modified Delphi study
    Blaschke, S-M ; Lambert, SD ; Livingston, PM ; Aranda, S ; Boltong, A ; Schofield, P ; Chambers, SK ; Krishnasamy, M ; Ugalde, A (BMJ PUBLISHING GROUP, 2019-06)
    INTRODUCTION: Cancer is often considered a chronic disease, and most people with cancer have a caregiver, often a family member or friend who provides a significant amount of care during the illness trajectory. Caregivers are frequently in need of support, and a range of interventions have been trialled to improve outcomes. Consensus for optimal ways to support caregivers is not known. The aim of this protocol paper is to describe procedures for a modified Delphi study to explore expert consensus about important factors when developing caregiver interventions. METHODS AND ANALYSIS: Online modified Delphi methodology will be used to establish consensus for important caregiver intervention factors incorporating the Patient problem, Intervention, Comparison and Outcome framework. Round 1 will comprise a free-text questionnaire and invite the panel to contribute factors they deem important in the development and evaluation of caregiver interventions. Round 2 is designed to determine preliminary consensus of the importance of factors generated in round 1. The panel will be asked to rate each factor using a 4-point Likert-type scale. The option for panellists to state reasoning for their rating will be provided. Descriptive statistics (median scores and IQR) will be calculated to determine each item's relative importance. Levels of consensus will be assessed based on a predefined consensus rating matrix. In round 3, factors will be recirculated including aggregate group responses (statistics and comment summaries) and panellists' own round 2 scores. Panellists will be invited to reconsider their judgements and resubmit ratings using the same rating system as in round 2. This will result in priority lists based on the panel's total rating scores. ETHICS AND DISSEMINATION: Ethics for this study has been gained from the Deakin University Human Ethics Advisory Group. It is anticipated that the results will be published in peer-reviewed journals and presented in a variety of forums.
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    Understanding rural caregivers' experiences of cancer care when accessing metropolitan cancer services: a qualitative study
    Ugalde, A ; Blaschke, S ; Boltong, A ; Schofield, P ; Aranda, S ; Phipps-Nelson, J ; Chambers, SK ; Krishnasamy, M ; Livingston, PM (BMJ PUBLISHING GROUP, 2019-08)
    OBJECTIVE: To explore the experiences of cancer caregivers who live in rural Australia and travel to a metropolitan cancer health service to access cancer treatment. DESIGN: A qualitative study using semistructured, audio-recorded interviews conducted between December 2017 and July 2018 with caregivers and social workers. Thematic analysis using interpretative descriptive techniques performed on textual interview data within a critical realist paradigm to develop understanding of rural caregivers' lived experiences. SETTING: Participants were from rural areas attending a metropolitan cancer centre in Australia and social workers. PARTICIPANTS: 21 caregivers (16 female) of people with cancer living in rural Australia within a minimum distance of 100 km from the metropolitan cancer centre where they access treatment, and five social workers employed at a metropolitan cancer service with experience of working with rural patients and caregivers. RESULTS: Thematic analysis developed two overarching themes: theme 1: caregiving in the rural setting describes the unique circumstance in which caregiving for a person with cancer takes place in the rural setting at considerable distance from the cancer service where the person receives treatment. This is explored in three categories: 'Rural community and culture', 'Life adjustments' and 'Available supports'. Theme 2: accessing metropolitan cancer services captures the multiplicity of tasks and challenges involved in organising and coordinating the journey to access cancer treatment in a metropolitan hospital, which is presented in the following categories: 'Travel', 'Accommodation' and 'Health system navigation'. CONCLUSIONS: Caregivers who live in rural areas face significant challenges when confronting geographic isolation between their rural home environment and the metropolitan setting, where the patient accessed cancer treatment. There is a need for healthcare services to identify this group to develop feasible and sustainable ways to provide interventions that have the best chance of assisting rural caregivers in supporting the patient while maintaining their own health and well-being.
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    Multidisciplinary home-based rehabilitation in inoperable lung cancer: a randomised controlled trial
    Edbrooke, L ; Aranda, S ; Granger, CL ; McDonald, CF ; Krishnasamy, M ; Mileshkin, L ; Clark, RA ; Gordon, I ; Irving, L ; Denehy, L (BMJ PUBLISHING GROUP, 2019-08)
    BACKGROUND: Lung cancer is associated with poor health-related quality of life (HRQoL) and high symptom burden. This trial aimed to assess the efficacy of home-based rehabilitation versus usual care in inoperable lung cancer. METHODS: A parallel-group, assessor-blinded, allocation-concealed, randomised controlled trial. Eligible participants were allocated (1:1) to usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone. Assessments occurred at baseline, 9 weeks and 6 months. The primary outcome, change in between-group 6 min walk distance (6MWD), was analysed using intention-to-treat (ITT). Subsequent analyses involved modified ITT (mITT) and included participants with at least one follow-up outcome measure. Secondary outcomes included HRQoL and symptoms. RESULTS: Ninety-two participants were recruited. Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46%. There were no significant between-group differences for the 6MWD (n=92) at 9 weeks (p=0.308) or 6 months (p=0.979). The mITT analyses of 6MWD between-group differences were again non-significant (mean difference (95% CI): 9 weeks: -25.4 m (-64.0 to 13.3), p=0.198 and 6 months: 41.3 m (-26.7 to 109.4), p=0.232). Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy-Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory-Lung Cancer: -2.2 (-3.6 to -0.9), p=0.001). CONCLUSIONS: Home-based rehabilitation did not improve functional exercise capacity but there were improvements in patient-reported exploratory secondary outcomes measures observed at 6 months. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614001268639).
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    Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial
    Edbrooke, L ; Aranda, S ; Granger, CL ; McDonald, CF ; Krishnasamy, M ; Mileshkin, L ; Irving, L ; Braat, S ; Clark, RA ; Gordon, I ; Denehy, L (BMC, 2017-09-29)
    BACKGROUND: Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. METHODS: This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. DISCUSSION: There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. TRIAL REGISTRATION: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14).
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    A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial
    Schofield, P ; Juraskova, I ; Bergin, R ; Gough, K ; Mileshkin, L ; Krishnasamy, M ; White, K ; Bernshaw, D ; Penberthy, S ; Aranda, S (BMC, 2013-02-11)
    BACKGROUND: Women who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women's informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis. METHODS/DESIGN: This multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy. DISCUSSION: This timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12611000744954.