The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care.

BACKGROUND: The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. METHODS: The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18-65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. DISCUSSION: This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.

The Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening.

BACKGROUND: A risk-stratified approach to colorectal cancer (CRC) screening could result in a more acceptable balance of benefits and harms, and be more cost-effective. AIM: To determine the effect of a consultation in general practice using a computerised risk assessment and decision support tool (Colorectal cancer RISk Prediction, CRISP) on risk-appropriate CRC screening. DESIGN AND SETTING: Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018. METHOD: Participants were recruited from a consecutive sample of patients aged 50-74 years attending their GP. Intervention consultations included CRC risk assessment using the CRISP tool and discussion of CRC screening recommendations. Control group consultations focused on lifestyle CRC risk factors. The primary outcome was risk-appropriate CRC screening at 12 months. RESULTS: A total of 734 participants (65.1% of eligible patients) were randomised (369 intervention, 365 control); the primary outcome was determined for 722 (362 intervention, 360 control). There was a 6.5% absolute increase (95% confidence interval [CI] = -0.28 to 13.2) in risk-appropriate screening in the intervention compared with the control group (71.5% versus 65.0%; odds ratio [OR] 1.36, 95% CI = 0.99 to 1.86, P = 0.057). In those due CRC screening during follow-up, there was a 20.3% (95% CI = 10.3 to 30.4) increase (intervention 59.8% versus control 38.9%; OR 2.31, 95% CI = 1.51 to 3.53, P<0.001) principally by increasing faecal occult blood testing in those at average risk. CONCLUSION: A risk assessment and decision support tool increases risk-appropriate CRC screening in those due screening. The CRISP intervention could commence in people in their fifth decade to ensure people start CRC screening at the optimal age with the most cost-effective test.

Designing a decision aid for cancer prevention: a qualitative study.

OBJECTIVES: Australian guidelines recommend people aged 50-70 years old consider taking low-dose aspirin to reduce their risk of colorectal cancer. The aim was to design sex-specific decision aids (DAs) with clinician and consumer input, including expected frequency trees (EFTs) to communicate the risks and benefits of taking aspirin. METHODS: Semi-structured interviews were conducted with clinicians. Focus groups were conducted with consumers. The interview schedules covered ease of comprehension, design, potential effects on decision-making, and approaches to implementation of the DAs. Thematic analysis was employed; independent coding by 2 researchers was inductive. Themes were developed through consensus between authors. RESULTS: Sixty-four clinicians were interviewed over 6 months in 2019. Twelve consumers aged 50-70 years participated in two focus groups in February and March 2020. The clinicians agreed that the EFTs would be helpful to facilitate a discussion with patients but suggested including an additional estimate of the effects of aspirin on all-cause mortality. The consumers felt favourable about the DAs and suggested changes to the design and wording to ease comprehension. CONCLUSION: DAs were designed to communicate the risks and benefits of low-dose aspirin for disease prevention. The DAs are currently being trialled in general practice to determine their impact on informed decision-making and aspirin uptake.

Aspirin can help to prevent bowel cancer up by to 25% and the chances of dying from it by up to 33%. Australian guidelines recommend that people aged 50­70 years old to consider taking low-dose aspirin to reduce their risk of bowel cancer. To encourage GPs and their patients to discuss the guidelines, we designed a brochure called a decision aid with the help of clinicians and people in the community of Victoria, Australia. The decision aid covered the benefits and risks of taking aspirin. Clinicians participated in interviews and provided feedback on the statistics presented in a chart called an expected frequency tree. People in the community participated in group discussions and improved the design and comprehension of the decision aid. The clinicians and people who participated in this study do not fully represent the diversity of the Australian population, as they were mostly white and highly educated. We are now testing if the decision aid is effective for supporting a discussion between patients and general practitioners, helping their patients make an informed decision about taking aspirin, and whether it encourages them to take aspirin daily after being shown the decision aid in general practice.

The nature and impact of patient and public involvement in cancer prevention, screening and early detection research: A systematic review.

Patient and public involvement can produce high-quality, relevant research that better addresses the needs of patients and their families. This systematic review investigated the nature and impact of patient and public involvement in cancer prevention, screening and early detection research. Two patient representatives were involved as members of the review team. Databases (Medline, EMBASE, Emcare, Involve Evidence Library) were searched for English-language studies published 1995-March 2022. Titles/abstracts were screened by two reviewers independently. For eligible studies, data were extracted on study characteristics, patient and public involvement (who, when, how, and impact on research outcomes), and reporting quality using the Guidance for Reporting Involvement of Patients and the Public 2-Short Form. Of 4095 articles screened, 58 were eligible. Most research was from the United States (81%) and examined cancer screening or prevention (82%). Community members/organisations/public were the most involved (71%); fewer studies involved patients and/or carers (14%). Over half reported a high-level of involvement (i.e. partner and/or expert involvement), although this declined in later stages of the research cycle, e.g. data analysis. Common positive impacts included improved study design, research methods and recruitment, although most papers (62%) did not describe methods to determine impact. Reporting quality was sub-optimal, largely due to failure to consider challenges. This review found that high-level involvement of patients and the public in cancer prevention, screening and early detection research is feasible and has several advantages. However, improvements are needed to encourage involvement across the research cycle, and in evaluating and reporting its impact.

The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care.

BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation. METHODS: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery. DISCUSSION: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021.

Exploring a novel method for optimising the implementation of a colorectal cancer risk prediction tool into primary care: a qualitative study.

BACKGROUND: We developed a colorectal cancer risk prediction tool ('CRISP') to provide individualised risk-based advice for colorectal cancer screening. Using known environmental, behavioural, and familial risk factors, CRISP was designed to facilitate tailored screening advice to patients aged 50 to 74 years in general practice. In parallel to a randomised controlled trial of the CRISP tool, we developed and evaluated an evidence-based implementation strategy. METHODS: Qualitative methods were used to explore the implementation of CRISP in general practice. Using one general practice in regional Victoria, Australia, as a 'laboratory', we tested ways to embed CRISP into routine clinical practice. General practitioners, nurses, and operations manager co-designed the implementation methods with researchers, focussing on existing practice processes that would be sustainable. Researchers interviewed the staff regularly to assess the successfulness of the strategies employed, and implementation methods were adapted throughout the study period in response to feedback from qualitative interviews. The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide and intervention strategy. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains and a fidelity checklist was developed to ensure CRISP was being used as intended. RESULTS: Between December 2016 and September 2019, 1 interviews were conducted, both face-to-face and via videoconferencing (Zoom). All interviews were transcribed verbatim and coded. Themes were mapped onto the following CFIR domains: (1) 'characteristics of the intervention': CRISP was valued but time consuming; (2) 'inner setting': the practice was open to changing systems; 3. 'outer setting': CRISP helped facilitate screening; (4) 'individual characteristics': the practice staff were adaptable and able to facilitate adoption of new clinical processes; and (5) 'processes': fidelity checking, and education was important. CONCLUSIONS: These results describe a novel method for exploring implementation strategies for a colorectal cancer risk prediction tool in the context of a parallel RCT testing clinical efficacy. The study identified successful and unsuccessful implementation strategies using an adaptive methodology over time. This method emphasised the importance of co-design input to make an intervention like CRISP sustainable for use in other practices and with other risk tools.

The SYMPTOM-upper gastrointestinal study: A mixed methods study exploring symptom appraisal and help-seeking in Australian upper gastrointestinal cancer patients.

OBJECTIVE: There is limited evidence on the development of pancreatic and oesophagogastric cancer, how patients decide to seek help and the factors impacting help-seeking. Our study, the first in Australia, aimed to explore symptom appraisal and diagnostic pathways in these patients. A secondary aim was to examine the potential to recruit cancer patients through a cancer quality registry. METHODS: Patients diagnosed with pancreatic or oesophagogastric cancer were recruited through Monash University's Upper-Gastrointestinal Cancer Registry. Data collected through general practitioners (GP) and patient questionnaires included symptoms and their onset, whereas patient interviews focused on the patient's decision-making in seeking help from healthcare pracitioners. Data collection and analysis was informed by the Aarhus statement. Coding was inductive, and themes were mapped onto the Model of Pathways to Treatment. RESULTS: Between November 2018 and March 2020, 27 patient questionnaires and 13 phone interviews were completed. Prior to diagnosis, patients lacked awareness of pancreatic and oesophagogastric cancer symptoms, leading to the normalisation, dismissal and misattribution of the symptoms. Patients initially self-managed symptoms, but worsening of symptoms and jaundice triggered help-seeking. Competing priorities, beliefs about illnesses and difficulties accessing healthcare delayed help-seeking. CONCLUSION: Increased awareness of insidious pancreatic and oesophagogastric cancer symptoms in patients and general practitioners may prompt more urgent investigations and lead to earlier diagnosis.

Informed choice and attitudes regarding a genomic test to predict risk of colorectal cancer in general practice.

OBJECTIVE: A genomic test to predict personal risk of colorectal cancer (CRC) that targets screening and could be feasibly implemented in primary care. We explored informed decision-making and attitudes towards genomic testing in this setting. METHODS: A CRC genomic test was offered to 150 general practice patients with brief discussion of its implications. We measured informed choice about the test, consisting knowledge, attitudes and test uptake. Sixteen purposively-sampled participants were interviewed. RESULTS: Of 150, 142 (95%) completed the informed choice measure and of 27 invited, 16 (59%) completed an interview. 73% made an informed choice about the test. Interviews revealed that participants with inadequate knowledge on the informed choice scale still understood the gist of the test. While positive attitudes were most prevalent, some had concerns, and many were indifferent to the test. Positive attitudes included: that risk information could facilitate risk reduction; negative attitudes included: that risk results could cause worry and be used for insurance discrimination; indifferent attitudes included: that the test seemed benign and it was easy to do. CONCLUSIONS: Our study adds to the evidence that genomic tests for CRC risk do not pose significant concern to patients in community settings. PRACTICE IMPLICATIONS: As genomic tests become more prevalent, this study's findings can be used to facilitate informed decision-making and ensure equitable access.

Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19.

BACKGROUND: Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020. MAIN BODY: We originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies. CONCLUSION: We developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic.

An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial.

BACKGROUND: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin. METHODS: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. DISCUSSION: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.

Clinicians' opinions on recommending aspirin to prevent colorectal cancer to Australians aged 50-70 years: a qualitative study.

OBJECTIVES: Australian guidelines recommend all adults aged 50-70 years old without existing contraindications consider taking low-dose aspirin (100-300 mg per day) for at least 2.5 years to reduce their risk of developing colorectal cancer. We aimed to explore clinicians' practices, knowledge, opinions, and barriers and facilitators to the implementation of these new guidelines. METHODS: Semistructured interviews were conducted with clinicians to whom the new guidelines may be applicable (Familial Cancer Clinic staff (geneticists, oncologists and genetic counsellors), gastroenterologists, pharmacists and general practitioners (GPs)). The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains: characteristics of the intervention, outer setting, inner setting, individual characteristics and process. RESULTS: Sixty-four interviews were completed between March and October 2019. Aspirin was viewed as a safe and cheap option for cancer prevention. GPs were considered by all clinicians as the most important health professionals for implementation of the guidelines. Cancer Council Australia, as a trusted organisation, was an important facilitator to guideline adoption. Uncertainty about aspirin dosage and perceived strength of the evidence, precise wording of the recommendation, previous changes to guidelines about aspirin and conflicting findings from trials in older populations were barriers to implementation. CONCLUSION: Widespread adoption of these new guidelines could be an important strategy to reduce the incidence of bowel cancer, but this will require more active implementation strategies focused on primary care and the wider community. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620001003965).

Effects of a wearable technology-based physical activity intervention on sleep quality in breast cancer survivors: the ACTIVATE Trial.

INTRODUCTION: Physical activity interventions can improve sleep quality in breast cancer survivors. This paper examines the effects of the ACTIVATE Trial, a wearable-based physical activity intervention (Garmin Vivofit2® coupled with behavioral feedback, goal setting, and health coaching) on sleep outcomes. METHODS: Post-primary treatment, inactive, postmenopausal breast cancer survivors were recruited and randomized to primary intervention or waitlist. Wrist-worn actigraphy (sleep onset latency, SOL; total sleep time, TST; sleep efficiency, SE; wake after sleep onset, WASO; and number of awakenings, NWAKE) and questionnaire-derived sleep measures (Pittsburgh Sleep Quality Index) were assessed at baseline (T1), 12 weeks (end of primary intervention and start of waitlist intervention, T2), and at 24 weeks (T3). RESULTS: Eighty-three women (mean age = 62 years) were randomized; trial retention was 94% at T2 and 87% at T3. At T2, primary intervention participants had greater improvements in WASO (- 5.7 min, 95% CI - 11.7 to - 0.2) and NWAKE compared with the waitlist arm (- 2.0, 95% CI - 3.6 to - 0.4). At T3, within-group improvements were observed for SE (both groups), WASO (both groups), NWAKE (primary intervention group only), total PSQI score (primary intervention group), and sleep efficacy (primary intervention group). CONCLUSIONS: The intervention reduced actigraphy-measured sleep disturbances. Within-group analyses suggest that improvements in sleep quality are sustained over a longer duration, and there may be similar benefits from an abridged intervention (wearable device only). Actigraphy-measured effects appeared stronger in participants who were poor sleepers at study entry. IMPLICATIONS FOR CANCER SURVIVORS: Wearable technology can increase physical activity and improve sleep for breast cancer survivors.

A Genomic Test for Colorectal Cancer Risk: Is This Acceptable and Feasible in Primary Care?

INTRODUCTION: Genomic tests can predict risk and tailor screening recommendations for colorectal cancer (CRC). Primary care could be suitable for their widespread implementation. OBJECTIVE: We aimed to assess the feasibility and acceptability of administering a CRC genomic test in primary care. METHODS: Participants aged 45-74 years recruited from 4 Australian general practices were offered a genomic CRC risk test. Participants received brief verbal information about the test comprising 45 CRC-associated single-nucleotide polymorphisms, before choosing whether to undertake the test. Personalized risks were given to testers. Uptake and knowledge of the genomic test, cancer-specific anxiety (Cancer Worry Scale), psychosocial impact (Multidimensional Impact of Cancer Risk Assessment [MICRA] score), and impact on CRC screening behaviour within 6 months were measured. RESULTS: In 150 participants, test uptake was high (126, 84%), with 125 (83%) having good knowledge of the genomic test. Moderate risk participants were impacted more by the test (MICRA mean: 15.9) than average risk participants (mean: 9.5, difference in means: 6.4, 95% confidence interval (CI): 1.5, 11.2, p = 0.01), but all scores were low. Average risk participants' cancer-specific anxiety decreased (mean differences from baseline: 1 month -0.5, 95% CI: -1.0, -0.1, p = 0.03; 6 months -0.6, 95% CI: -1.0, -0.2, p = 0.01). We found limited evidence for genomic testers being more likely to complete the risk-appropriate CRC screening than non-testers (41 vs. 17%, odds ratio = 3.4, 95% CI: 0.6, 34.8, p = 0.19), but some mediators of screening behaviour were altered in genomic testers. CONCLUSIONS: Genomic testing for CRC risk in primary care is acceptable and likely feasible. Further development of the risk assessment intervention could strengthen the impact on screening behaviour.

Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors.

BACKGROUND: The ACTIVATE Trial examined the efficacy of a wearable-based intervention to increase physical activity and reduce sedentary behavior in breast cancer survivors. This paper examines the effects of the intervention on health-related quality of life (HRQoL) and fatigue at 12 weeks (T2; end of intervention) and 24 weeks (T3; follow-up). METHODS: Inactive and postmenopausal women who had completed primary treatment for stage I-III breast cancer were randomized to intervention or waitlist control. Physical activity and sedentary behavior were measured by Actigraph and activPAL accelerometers at baseline (T1), end of the intervention (T2), and 12 weeks follow-up (T3). HRQoL and fatigue were measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Primary intervention effects were evaluated comparing intervention and waitlist group at T2 using repeated measures mixed effects models. RESULTS: Overall, 83 women were randomized and trial retention was high (94%). A 4.6-point difference in fatigue score was observed between groups at T2 (95% CI: 1.3, 7.8) indicating improvement in fatigue profiles in the intervention group. In within groups analyses, the intervention group reported a 5.1-point increase in fatigue from baseline to T2 (95% CI: 2.0, 8.2) and a 3.3-point increase from baseline to T3 (95% CI: 0.1, 6.41). CONCLUSIONS: Despite small improvements in fatigue profiles, no effects on HRQoL were observed. While the ACTIVATE Trial was associated with improvements in physical activity and sedentary behavior, more intensive or longer duration interventions may be needed to facilitate changes in HRQoL.

Decision support tools to improve cancer diagnostic decision making in primary care: a systematic review.

BACKGROUND: The diagnosis of cancer in primary care is complex and challenging. Electronic clinical decision support tools (eCDSTs) have been proposed as an approach to improve GP decision making, but no systematic review has examined their role in cancer diagnosis. AIM: To investigate whether eCDSTs improve diagnostic decision making for cancer in primary care and to determine which elements influence successful implementation. DESIGN AND SETTING: A systematic review of relevant studies conducted worldwide and published in English between 1 January 1998 and 31 December 2018. METHOD: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, and a consultation of reference lists and citation tracking was carried out. Exclusion criteria included the absence of eCDSTs used in asymptomatic populations, and studies that did not involve support delivered to the GP. The most relevant Joanna Briggs Institute Critical Appraisal Checklists were applied according to study design of the included paper. RESULTS: Of the nine studies included, three showed improvements in decision making for cancer diagnosis, three demonstrated positive effects on secondary clinical or health service outcomes such as prescribing, quality of referrals, or cost-effectiveness, and one study found a reduction in time to cancer diagnosis. Barriers to implementation included trust, the compatibility of eCDST recommendations with the GP's role as a gatekeeper, and impact on workflow. CONCLUSION: eCDSTs have the capacity to improve decision making for a cancer diagnosis, but the optimal mode of delivery remains unclear. Although such tools could assist GPs in the future, further well-designed trials of all eCDSTs are needed to determine their cost-effectiveness and the most appropriate implementation methods.

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial.

BACKGROUND: This brief report examines the maintenance of moderate to vigorous physical activity (MVPA) and sedentary behavior changes approximately 12 weeks after the delivery of the ACTIVATE Trial primary intervention (use of the Garmin Vivofit 2 activity tracker coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions). We also examine the efficacy of an abridged intervention (use of the Garmin Vivofit 2 only) in the waitlist control group. METHODS: A pre-post design was employed to examine the secondary aims of the ACTIVATE Trial (n = 80; mean age = 62 years). MVPA and sedentary behavior were measured using Actigraph and activPAL accelerometers after delivery of the primary intervention (T2), and again 12 weeks later (T3). Linear mixed models with random effects were used to examine within-group changes in MVPA and sitting time variables. RESULTS: After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3 = 14 min/wk; 95% CI = -18 to 46; P = .37). However, their sitting time increased slightly, by 7 min/d (95% CI = -20 to 34; P = .58), but it did not return to its preintervention level. After receiving the Garmin Vivofit 2, the waitlist control group increased their MVPA by 33 min/wk (95% CI = 3-64; P = .03) and reduced their sitting time by 38 min/d (95% CI = -69 to -7; P = .02) over the same 12-week period. CONCLUSION: The secondary outcomes from the ACTIVATE Trial suggest that wearable technology may generate sustainable changes in MVPA and sitting time. Wearable technology alone may be sufficient to change behavior, at least in the short term.

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial.

BACKGROUND: The benefits of an active lifestyle after a breast cancer diagnosis are well recognized, but the majority of survivors are insufficiently active. The ACTIVATE Trial examined the efficacy of an intervention (use of the Garmin Vivofit 2 activity monitor coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions) to increase moderate to vigorous physical activity (MVPA) and reduce sedentary behavior in breast cancer survivors. METHODS: This randomized controlled trial recruited 83 inactive, postmenopausal women diagnosed with stage I-III breast cancer who had completed primary treatment. Participants were randomly assigned to the intervention group or to the control group, and the intervention was delivered over a 12-week period. MVPA and sedentary behavior were measured with Actigraph and activPAL accelerometers at baseline (T1) and at the end of the intervention (T2). RESULTS: Retention in the trial was high, with 80 (96%) of participants completing T2 data collection. At T2, there was a significant between-group difference in MVPA (69 min/wk; 95% CI = 22-116) favoring the intervention group. The trial resulted in a statistically significant decrease in both total sitting time and prolonged bouts (≥20 min) of sitting, with between-group reductions of 37 min/d (95% CI = -72 to -2) and 42 min/d (95% CI = -83 to -2), respectively, favoring the intervention group. CONCLUSION: Results from the ACTIVATE Trial suggest that the use of wearable technology presents an inexpensive and scalable opportunity to facilitate more active lifestyles for cancer survivors. Whether or not such wearable technology-based interventions can create sustainable behavioral change should be the subject of future research.

The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial.

BACKGROUND: Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of the immunochemical faecal occult blood test, poor identification of individuals at increased risk of colorectal cancer, and over-referral of individuals at average risk for colonoscopy. Our pre-trial research has developed a novel Colorectal cancer RISk Prediction (CRISP) tool, which could be used to implement precision screening in primary care. This paper describes the protocol for a phase II multi-site individually randomised controlled trial of the CRISP tool in primary care. METHODS: This trial aims to test whether a standardised consultation using the CRISP tool in general practice (the CRISP intervention) increases risk-appropriate colorectal cancer screening compared to control participants who receive standardised information on cancer prevention. Patients between 50 and 74 years old, attending an appointment with their general practitioner for any reason, will be invited into the trial. A total of 732 participants will be randomised to intervention or control arms using a computer-generated allocation sequence stratified by general practice. The primary outcome (risk-appropriate screening at 12 months) will be measured using baseline data for colorectal cancer risk and objective health service data to measure screening behaviour. Secondary outcomes will include participant cancer risk perception, anxiety, cancer worry, screening intentions and health service utilisation measured at 1, 6 and 12 months post randomisation. DISCUSSION: This trial tests a systematic approach to implementing risk-stratified colorectal cancer screening in primary care, based on an individual's absolute risk, using a state-of-the-art risk assessment tool. Trial results will be reported in 2020. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry, ACTRN12616001573448p . Registered on 14 November 2016.