Study preregistration is one of several “open science” practices (e.g., open data, preprints) that researchers use to improve the transparency and rigour of their research. As more researchers adopt preregistration as a regular research practice, examining the nature and content of preregistrations can help identify strengths and weaknesses of current practices. The value of preregistration, in part, relates to the specificity of the study plan and the extent to which investigators adhere to this plan. We identified 53 preregistrations from the gambling studies field meeting our predefined eligibility criteria and scored their level of specificity using a 23-item protocol developed to measure the extent to which a clear and exhaustive preregistration plan restricts various researcher degrees of freedom (RDoF; i.e., the many methodological choices available to researchers when collecting and analysing data, and when reporting their findings). We also scored studies on a 32-item protocol that measured adherence to the preregistered plan in the study manuscript. We found that gambling preregistrations had low specificity levels on most RDoF. However, a comparison with a sample of cross-disciplinary preregistrations (N = 52; Bakker et al., 2020) indicated that gambling preregistrations scored higher on 12 (of 29) items. Thirteen (65%) of the 20 associated published articles or preprints deviated from the protocol without declaring as much (the mean number of undeclared deviations per article was 2.25, SD = 2.34). Overall, while we found improvements in specificity and adherence over time (2017-2020), our findings suggest the purported benefits of preregistration—including increasing transparency and reducing RDoF—are not fully achieved by current practices. Using our findings, we provide 10 practical recommendations that can be used to support and refine preregistration practices.

Gambling self-exclusion programs are under-utilised and barriers to entry include shame and embarrassment with face-to-face registration, and complex and effortful procedures. The current study aimed to facilitate self-exclusion from gambling venues via an online self-directed website. A co-design approach was used to elicit key stakeholders' perspectives on required website features, functionality, and to identify variables potentially impacting on development and implementation. Semi-structured focus groups and interviews were conducted across four stakeholders ( N = 25): self-exclusion end users (consumers, n = 5), gambling counsellors ( n = 7), venue staff ( n = 6), and policy makers ( n = 7). Overall, stakeholder perspectives were consistent with content analysis indicating the importance of website user-friendliness, flexibility, supportiveness, and trustworthiness. Importantly, these attributes were linked to target end users': perceived vulnerabilities, diverse backgrounds and individual expectations. Participants believed that the entire self-exclusion process should be conducted online, including identity verification, whilst expecting high-level data security measures to protect their personal privacy. A separate webpage was also suggested containing relevant information and links to additional help services, such as counselling. This study describes an adaptable co-design framework for developing a usable and acceptable self-exclusion website. Future studies should empirically test system usability and acceptability to refine and maximise system uptake upon implementation. Findings may have broader implications for digital health intervention design.

PURPOSE: Fear of cancer recurrence (FCR) affects 50%-70% of cancer survivors. This multicenter, single-arm study sought to determine the participant-rated usefulness of an oncologist-delivered FCR intervention. METHODS: Women who completed treatment for early breast cancer (could be receiving endocrine therapy) with baseline FCR > 0 were invited to participate. FCR was measured using a validated 42-item FCR Inventory. The brief oncologist-delivered intervention entailed (1) FCR normalization; (2) provision of personalized prognostic information; (3) recurrence symptoms education, (4) advice on managing worry, and (5) referral to psycho-oncologist if FCR was high. FCR, depression, and anxiety were assessed preintervention (T0), at 1 week (T1), and 3 months (T2) postintervention. The primary outcome was participant-rated usefulness. Secondary outcomes included feasibility and efficacy. RESULTS: Five oncologists delivered the intervention to 61/255 women invited. Mean age was 58 ± 12 years. Mean time since breast cancer diagnosis was 2.5 ± 1.3 years. Forty-three women (71%) were on adjuvant endocrine therapy. Of 58 women who completed T1 assessment, 56 (97%) found the intervention to be useful. FCR severity decreased significantly at T1 (F = 18.5, effect size = 0.39, P < .0001) and T2 (F = 24, effect size = 0.68, P < .0001) compared with baseline. There were no changes in unmet need or depression or anxiety. Mean consultation length was 22 minutes (range, 7-47 minutes), and mean intervention length was 8 minutes (range, 2-20 minutes). The intervention was perceived as useful and feasible by oncologists. CONCLUSION: A brief oncologist-delivered intervention to address FCR is useful and feasible, and has preliminary efficacy in reducing FCR. Plans for a cluster randomized trial are underway.

12115 Background: FCR affects 50-70% of cancer survivors. There are no validated oncologist-delivered FCR interventions. This multicentre, single-arm study sought to determine the helpfulness, feasibility and efficacy of an oncologist-delivered FCR intervention. Methods: Women were invited to participate if they had completed local treatment, chemotherapy and/or HER2 targeted therapy for early stage breast cancer and had a FCR score >0 on the 42-item FCR Inventory. The brief intervention, delivered by their medical oncologist at routine follow-up, entailed 1) FCR normalisation; 2) provision of personalised prognostic information; 3) take-home education sheet on recurrence symptoms; and 4) advice on managing worry. Consultations were audio-recorded. FCR, need for help, depression and anxiety were assessed before the intervention (T0), and at one week (T1) and three months (T2) after the intervention. Satisfaction with the intervention was assessed at T1. The primary outcome was participant-rated helpfulness. Secondary outcomes included feasibility (response rate, time taken for intervention) and efficacy. Results: Five oncologists delivered the intervention to 61 women (255 women invited; response rate 24%). The mean age was 57 ± 13 years. The mean time since breast cancer diagnosis was 2.5 ± 1.3 years. Forty-three (72%) were on adjuvant hormonal therapy. Overall, 58 women (95%) found the intervention helpful and 59 (98%) would recommend it to others. FCR severity, and the proportion of women with clinically significant FCR decreased significantly over time. There were no significant changes in unmet need, depression, or anxiety. Forty (66%) of consultations were recorded. Mean consultation length was 22 minutes (range 12-37 minutes) and mean intervention length was 9 minutes (3-20 minutes). The intervention was perceived as useful and feasible by oncologists, all of whom have used components of the intervention to help manage FCR in other breast cancer patients. Conclusions: A brief oncologist-delivered intervention to address FCR is helpful and feasible, and has shown preliminary efficacy in reducing FCR. Plans for an implementation study amongst oncologists in Australia are underway. Clinical trial information: ACTRN12618001615279 . [Table: see text]