Dataset Information

Communicating risk in active surveillance of localised prostate cancer: a protocol for a qualitative study.

ABSTRACT:

Introduction

One in five men is likely to receive a diagnosis of prostate cancer (PCa) by the age of 85 years. Men diagnosed with low-risk PCa may be eligible for active surveillance (AS) to monitor their cancer to ensure that any changes are discovered and responded to in a timely way. Communication of risk in this context is more complicated than determining a numerical probability of risk, as patients wish to understand the implications of risk on their lives in concrete terms. Our study will examine how risk for PCa is perceived, experienced and communicated by patients using AS with their health professionals, and the implications for treatment and care.

Methods and analysis

This is a proof of concept study, testing out a multimethod, qualitative approach to data collection in the context of PCa for the first time in Australia. It is being conducted from November 2016 to December 2017 in an Australian university hospital urology clinic. Participants are 10 men with a diagnosis of localised PCa, who are using an AS protocol, and 5 health professionals who work with this patient group (eg, urologists and Pca nurses). Data will be collected using observations of patient consultations with health professionals, patient questionnaires and interviews, and interviews with healthcare professionals. Analysis will be conducted in two stages. First, observational data from consultations will be analysed thematically to encapsulate various dimensions of risk classification and consultation dialogue. Second, interview data will be coded to derive meaning in text and analysed thematically. Overarching themes will represent patient and health professional perspectives of risk communication.

Ethics and dissemination

Ethical approval for the study has been granted by Macquarie University Human Research Ethics Committee, approval 5201600638. Knowledge translation will be achieved through publications, reports and conference presentations to patients, families, clinicians and researchers.

SUBMITTER: Rapport F

PROVIDER: S-EPMC5640046 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Publications

Communicating risk in active surveillance of localised prostate cancer: a protocol for a qualitative study.

Rapport Frances F Hogden Anne A Gurney Howard H Gillatt David D Bierbaum Mia M Shih Patti P Churruca Kate K

BMJ open 20171005 10

<h4>Introduction</h4>One in five men is likely to receive a diagnosis of prostate cancer (PCa) by the age of 85 years. Men diagnosed with low-risk PCa may be eligible for active surveillance (AS) to monitor their cancer to ensure that any changes are discovered and responded to in a timely way. Communication of risk in this context is more complicated than determining a numerical probability of risk, as patients wish to understand the implications of risk on their lives in concrete terms. Our st ...[more]

PMID: 28982830

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Project description:ObjectiveLittle is known about clinicians' decision-making about decreasing active surveillance (AS) testing/converting patients to watchful waiting (WW), nor are there any guidelines. The objective of this study was to identify factors that clinicians consider when decreasing AS testing/converting to WW for men with prostate cancer.DesignExploratory qualitative study.SettingAll participants practiced in various institutions in the USA.ParticipantsEligible clinicians had to provide clinical care for patients with prostate cancer in the USA and speak English. Clinicians could be either urologists or radiation oncologists. Of the 24 clinicians, 83% were urologists representing 11 states, 92% were men and 62% were white.MethodsThis qualitative study used data from semi-structured interviews. Purposive sampling was used to ensure geographical variation in the USA. Data collection continued until thematic saturation was achieved. Framework analysis guided coding and identification of themes. Two researchers coded all transcripts independently, met to discuss and reached consensus.ResultsInterviews with clinicians demonstrated that testing or monitoring for AS or transitioning to WW is happening in practice, whether intentionally or unintentionally. Decisions to decrease AS were personalised and tailored to patients' health status. Life expectancy was the dominant factor that influenced decision, but clinicians were generally hesitant to specify an age when they would decrease AS or transition to WW. Fear that poor adherence could lead to missed progression and concerns about the medico-legal issue of not doing enough were cited as barriers to decreasing AS.ConclusionsThese findings suggest that in certain situations, AS frequency is reduced or transitioned to WW, yet decisions appear to be inconsistent and there are no significant barriers. These findings could inform further areas to explore when drafting recommendations that consider patients' values and preferences when making decisions about decreasing AS/converting to WW.

Project description:INTRODUCTION:Despite the development of new therapies for advanced prostate cancer, it remains the most common cause of cancer and the second leading cause of cancer death in men. It is critical to develop novel agents for the treatment of prostate cancer, particularly those that target aspects of androgen receptor (AR) signalling or prostate biology other than inhibition of androgen synthesis or AR binding. Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials. CDK4/6 inhibitors have evidence of efficacy in breast cancer, and have been shown to have activity in preclinical models of hormone sensitive and castrate resistant prostate cancer. The LEEP trial aims to assess the pharmacodynamic effects of LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor, in men undergoing radical prostatectomy for high-risk, localised prostate cancer. METHODS AND ANALYSIS:The multicentre randomised, controlled 4:1 two-arm, phase II, open label pharmacodynamic study will recruit 47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy. Participants who are randomised to receive the study treatment will be treated with LEE011 400?mg daily for 21 days for one cycle. The primary endpoint is the frequency of a 50% reduction in Ki-67 proliferation index from the pretreatment prostate biopsy compared to that present in prostate cancer tissue from radical prostatectomy. Secondary and tertiary endpoints include pharmacodynamic assessment of CDK4/6?cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis. ETHICS AND DISSEMINATION:The protocol was approved by a central ethics review committee (St Vincent's Hospital HREC) for all participating sites (HREC/17/SVH/294). Results will be disseminated in peer-reviewed journals and at scientific conferences. DRUG SUPPLY:Novartis. PROTOCOL VERSION:2.0, 30 May 2019 TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618000354280).

Project description:ObjectivesActive surveillance (AS) enables men with low risk, localised prostate cancer (PCa) to avoid radical treatment unless progression occurs; lack of reliable AS protocols to determine progression leaves uncertainties for men and clinicians. This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.DesignLongitudinal serial in-depth qualitative interviews every 2-3 years for a median 7 (range 6-14) years following diagnosis.SettingFour centres within the UK Protect trial.ParticipantsPurposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52-68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM. Eleven men continued with AM throughout the study period (median 7 years). Nine received radical treatment after a median 4 years (range 0.8-13.8 years).InterventionAM: 3-monthly serum prostate-specific antigen (PSA)-level assessment (year 1), 6-12 monthly thereafter; increase in PSA ≥50% during previous 12 months or patient/clinician concern triggered review.Main outcomesThematic analysis of 73 interviews identified strategies to accommodate uncertainty and anxiety of living with untreated cancer; implications for patient care.ResultsMen sought clarity, control or reassurance, with contextual factors mediating individual responses. Trust in the clinical team was critical for men in balancing anxiety and facilitating successful management change/continued monitoring. Only men from ProtecT were included; men outside ProtecT may have different experiences.ConclusionMen looked to clinicians for clarity, control and reassurance. Where provided, men felt comfortable continuing AM or having radical treatments when indicated. Clinicians build patient trust by clearly describing uncertainties, allowing patients control wherever possible and being aware of how context influences individual responses. Insights indicate need for supportive services to build trust and patient engagement over the long term.Trial registration numberISRCTN20141297; Pre-results.

Dataset Information

Communicating risk in active surveillance of localised prostate cancer: a protocol for a qualitative study.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Communicating risk in active surveillance of localised prostate cancer: a protocol for a qualitative study.

Similar Datasets

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