Michael Jefford

Improvement of informed consent and the quality of consent documents.

Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.

Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review.

PURPOSE Adverse effects of chemotherapy can be severe and can have a significant impact on a persons quality of life. With chemotherapy treatment increasingly administered in the ambulatory setting, there is a need for patients to be informed about effective self-care strategies to manage treatment adverse effects. Advice for patients needs to be based on evidence. This systematic review provides an overview of the intervention research in this area as well as an effectiveness review of nonpharmacologic (self-care) strategies evaluated in high-quality randomized controlled trials (RCTs). METHODS An extensive literature search was conducted to identify RCTs relating to self-care strategies for reducing nausea/vomiting, constipation, diarrhea, fatigue, hair loss, or mucositis. Relevant studies published in peer-reviewed journals between 1980 and August 2007 were included. Study characteristics, results and methodologic quality were examined. High-quality RCTs were further analyzed to establish the effectiveness of specific self-care strategies. RESULTS The search identified 77 RCTs. Findings from RCTs of reasonable quality provide limited support for cognitive distraction, exercise, hypnosis, relaxation, and systematic desensitization to reduce nausea and vomiting, psycho-education for fatigue, and scalp cooling to reduce hair loss. CONCLUSION Although some strategies seem promising, the quality of the RCTs was generally quite low, making it difficult to draw conclusions about the effectiveness of self-care strategies. Future studies require better design and reporting of methodologic issues to establish evidence-based self-care recommendations for people receiving chemotherapy.

The views of bowel cancer survivors and health care professionals regarding survivorship care plans and post treatment follow up

Goals of workIncreasing numbers of people survive cancer beyond diagnosis and treatment. Many survivors have ongoing needs and they may encounter fragmented, poorly coordinated follow up care. Survivorship care plans (SCP) have been promoted as a key aspect of survivorship care. This study aimed to survey key stakeholders in the care of people with colorectal cancer (survivors, primary care providers and hospital-based healthcare professionals) regarding follow-up and SCP.Patients and methodsIn study 1, cancer survivors completed a questionnaire regarding their follow-up and experiences during survivorship. Participants’ primary care physicians completed a phone interview regarding proposed SCP elements. A subgroup of survivors reviewed a sample SCP and participated in a phone interview regarding this. In study 2, healthcare professionals working with colorectal cancer patients completed a questionnaire regarding follow-up and proposed elements of a SCP.Main resultsTwenty survivors completed the questionnaire, 14 primary care providers completed a phone interview and 12 survivors reviewed the sample SCP.Ninety-five healthcare professionals (30 medical professionals and 65 nurses) completed the questionnaire. There was strong support for core elements of the SCP. Additionally, nurses and survivors expressed support for supportive care and psychosocial elements. There was lack of consensus regarding who should prepare and discuss the SCP.ConclusionsThere is strong support for the development and use of SCPs for bowel cancer survivors. There is some variation in opinion regarding ideal content of the SCP, who might prepare it, and how it might be discussed and utilised.Implications for Cancer SurvivorsOvercoming identified barriers to implementing SCPs for bowel cancer survivors is necessary for high quality cancer care.

Effectively discussing complementary and alternative medicine in a conventional oncology setting: Communication recommendations for clinicians

OBJECTIVE Justifiable concerns around the use of complementary and alternative medicines (CAM) amongst cancer patients are becoming increasingly prominent. The aim was to develop evidence-based guidelines to assist oncology health professionals (HP) to have respectful, balanced and useful discussions with patients about CAM. METHODS A systematic review was conducted, covering relevant literature from 1997 to 2007. The level of evidence was rated using a standardized rating system. The evidence was qualitatively synthesised into structured recommendations by a multidisciplinary team including a consumer. RESULTS The search identified 78 original papers; 36 directly related to discussing CAM. No randomized controlled trials specifically addressing the methods or benefits of discussing CAM were identified. Evidence based guidelines are presented as a sequence of recommended steps: (1) Elicit the persons understanding of their situation; (2) Respect cultural and linguistic diversity and different epistemological frameworks; (3) Ask questions about CAM use at critical points in the illness trajectory; (4) Explore details and actively listen; (5) Respond to the persons emotional state; (6) Discuss relevant concerns while respecting the persons beliefs; (7) Provide balanced, evidence-based advice; (8) Summarize discussions; (9) Document the discussion; (10) Monitor and follow-up. CONCLUSION This represents the first comprehensive guidelines for discussing CAM. PRACTICE IMPLICATIONS Given the concerns surrounding CAM use, it is critical to encourage informed decision-making about CAM and ultimately, improve outcomes for patients.

Health-Related Quality of Life in Patients With Advanced Colorectal Cancer Treated With Cetuximab: Overall and KRAS-Specific Results of the NCIC CTG and AGITG CO.17 Trial

PURPOSE National Cancer Institute of Canada Clinical Trials Group CO.17 demonstrated the antiepidermal growth factor receptor (anti-EGFR) monoclonal antibody cetuximab improves overall and progression-free survival in patients with advanced, chemotherapy-refractory colorectal cancer (CRC), particularly in patients with wild-type KRAS tumors. This article reports the health-related quality-of-life (HRQL) outcomes from CO.17. PATIENTS AND METHODS Patients (N = 572) with pretreated EGFR-detectable advanced CRC were randomly assigned to cetuximab and best supportive care (BSC) or to BSC alone. HRQL primary end points assessed by the EORTC QLQ-C30 were physical function (PF) and global health status (GHS); mean changes from baseline to 8 and 16 weeks were assessed. Post hoc analysis by KRAS mutation status was performed. RESULTS Questionnaire compliance was 94% at baseline, but it declined differentially (67% v 47% for cetuximab v BSC at 16 weeks). PF change scores were -3.9 for cetuximab and -8.6 for BSC (P = .046) at 8 weeks and were -5.9 and -12.5 for cetuximab and BSC, respectively, (P = .027) at 16 weeks. GHS change scores were -0.5 and -7.1 (P = .008) at 8 weeks and were -3.6 and -15.2 (P = .008) at 16 weeks for cetuximab and BSC, respectively. In patients who had tumors with wild-type KRAS status, cetuximab resulted in less PF deterioration at 8 weeks (-0.7 v -7.2; P = .11) and 16 weeks (-3.4 v -13.8; P = .008) compared with BSC. Patients with wild-type status who received cetuximab experienced improved GHS at 8 weeks, whereas patients who received BSC alone deteriorated (3.2 v -7.7; P = .002). Cetuximab preserved GHS at 16 weeks (-0.2 v -18.1; P < .001). No significant differences were noted between study arms for patients with mutated KRAS tumors. CONCLUSION Cetuximab offers important HRQL and survival benefits for pretreated patients with advanced, wild-type KRAS CRC.

Chemotherapy Dosing Strategies in the Obese, Elderly, and Thin Patient: Results of a Nationwide Survey

PURPOSE Determining the optimal starting dose of chemotherapy (CHT) presents a considerable challenge when using body-surface area (BSA)-based dosing, particularly in obese, elderly, or thin patients. We sought to document the range of approaches employed when administering CHT to these patients. METHODS A questionnaire was developed by a panel of oncologists and mailed to all members of the Medical Oncology Group of Australia. RESULTS From 315 oncologists, 188 responded (response rate 59.7%). BSA-based dosing is standard practice for 176 (97.2%) of the responding oncologists. In the adjuvant disease setting, 23 (12.7%) use ideal rather than actual body weight (BW) to calculate BSA, or choose whichever is less. When treating obese patients, only 6.1% of respondents routinely use actual BW. Of the remainder, 69.5% either cap the dose at 2 m(2) or use ideal BW. In underweight patients, 95% (n = 171) routinely calculate BSA using actual BW. Forty one respondents (22.7%) routinely reduce dose in the fit elderly. CONCLUSION This analysis of BSA-based CHT dosing methods demonstrates significant variability in practice. Based on evidence from adjuvant studies showing that actual BSA-based dosing is desirable, a substantial number of Australian patients are being underdosed. Further education, together with ongoing research, is required to optimize individualized dosing for efficacy and tolerability.

Development and pilot testing of a nurse-led posttreatment support package for bowel cancer survivors.

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. 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. Objectives: This study aimed to develop and pilot test an innovative supportive care program for people with potentially curative CRC. Methods: The SurvivorCare intervention was developed by a multidisciplinary team using 3 key principles: (1) promote patient involvement and engagement; (2) address the specific needs of individual patients, and (3) use evidence-based strategies to promote well-being and reduce treatment sequelae. It also addressed 4 essential components of survivorship planning, defined by the US Institute of Medicine. Ten survivors completed questionnaires and satisfaction interviews before and after receiving the intervention. Results: SurvivorCare comprises survivorship educational materials (booklet, DVD, and question prompt list), a tailored survivorship care plan, a tailored nurse-led end-of-treatment consultation, and 3 follow-up telephone calls. Pilot data demonstrated that survivors considered the intervention appropriate, relevant, and useful. Conclusions: SurvivorCare is a well-received, comprehensive intervention that will now be evaluated in a randomized controlled trial aiming to reduce distress and unmet needs and improve quality of life in CRC survivors. Implications for Practice: If SurvivorCare is shown to be effective, it will be possible to quickly and broadly disseminate this model of care.

Phase III Randomized, Placebo-Controlled Study of Cetuximab Plus Brivanib Alaninate Versus Cetuximab Plus Placebo in Patients With Metastatic, Chemotherapy-Refractory, Wild-Type K-RAS Colorectal Carcinoma: The NCIC Clinical Trials Group and AGITG CO.20 Trial

PURPOSE The antiepidermal growth factor receptor monoclonal antibody cetuximab has improved survival in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal cancer. The addition of brivanib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor and fibroblast growth factor receptor, to cetuximab has shown encouraging early clinical activity. PATIENTS AND METHODS Patients with metastatic colorectal cancer previously treated with combination chemotherapy were randomly assigned 1:1 to receive cetuximab 400 mg/m(2) intravenous loading dose followed by weekly maintenance of 250 mg/m(2) plus either brivanib 800 mg orally daily (arm A) or placebo (arm B). The primary end point was overall survival (OS). RESULTS A total of 750 patients were randomly assigned (376 in arm A and 374 in arm B). Median OS in the intent-to-treat population was 8.8 months in arm A and 8.1 months in arm B (hazard ratio [HR], 0.88; 95% CI, 0.74 to 1.03; P = .12). Median progression-free survival (PFS) was 5.0 months in arm A and 3.4 months in arm B (HR, 0.72; 95% CI, 0.62 to 0.84; P < .001). Partial responses observed (13.6% v 7.2%; P = .004) were higher in arm A. Incidence of any grade ≥ 3 adverse events was 78% in arm A and 53% in arm B. Fewer patients received ≥ 90% dose-intensity of both cetuximab (57% v 83%) and brivanib/placebo (48% v 87%) in arm A versus arm B, respectively. CONCLUSION Despite positive effects on PFS and objective response, cetuximab plus brivanib increased toxicity and did not significantly improve OS in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal cancer.

Implementing improved post-treatment care for cancer survivors in England, with reflections from Australia, Canada and the USA

Increasing cancer incidence together with improved survival rates are contributing to the growing number of cancer survivors. Survivors may encounter a range of potential effects as a result of the cancer itself or cancer treatments. Traditionally, the major focus of follow-up care has been on detection of cancer recurrence; however, the efficacy of such strategies is questionable. Traditional follow-up frequently fails to identify or adequately address many survivors’ concerns. Aftercare needs to be planned to enable better outcomes for survivors, while using scarce health-care resources efficiently. This review focuses on provision of survivorship care, rather than on research. England’s National Cancer Survivorship Initiative has developed principles for improved care of those living with and beyond cancer. These include risk-stratified pathways of care, the use of treatment summaries and care plans, information and education to enable choice and the confidence to self manage, rapid re-access to specialist care, remote monitoring and well-coordinated care. Many of these principles are relevant internationally, though preferred models of care will depend on local circumstances.

Preparing patients for threatening medical treatments: effects of a chemotherapy educational DVD on anxiety, unmet needs, and self-efficacy

Goals of workBased on meta-analyses regarding the preparation of patients for potentially threatening medical procedures, a DVD, incorporating behavioral role modelling, was developed to prepare patients for chemotherapy and assist them to self-manage side effects. It was hypothesized that patients who watched the DVD (vs those who did not) would report (1) lower anxiety; (2) higher self-efficacy related to coping with treatment side effects; (3) fewer supportive care needs; and (4) higher satisfaction with information received. It was further hypothesized that these effects would be stronger in those perceiving their treatment intent to be curative rather than palliative.Materials and methodsQuasi-experimental design using a historical control group was employed. Participants were scheduled to receive their first ever chemotherapy treatment. Group 1 (usual care; n = 50) was prospectively recruited before the release of the DVD and group 2 (DVD plus usual care; n = 50) after the release. Before commencing chemotherapy, all patients completed reliable and valid measures of self-efficacy, anxiety, and supportive care needs. Data was stratified according to perceived treatment intent. Independent sample t tests were performed for each group (curative vs palliative).Main resultsSignificant differences were found between the usual care and intervention groups: for self-perceived curative patients in relation to self-efficacy for seeking social support (p = 0.044), with increased confidence in those watching the DVD, and for self-perceived palliative patients in relation to their satisfaction with information about side effects (p = 0.026), with increased satisfaction in those watching the DVD. Overall, significant differences were found between self-perceived curative vs palliative patients on measures of self-efficacy and supportive care needs, with self-perceived curative patients reporting more confidence and fewer needs.ConclusionsThe educational DVD was considered highly acceptable by patients and was found to increase self-efficacy and reduce supportive care needs. Hence, it is appropriate to give to patients before face-to-face chemotherapy education. Additional pretreatment education is recommended, particularly for self-perceived palliative patients, to reduce their pretreatment anxiety and enhance their confidence in coping with treatment.