Sanela Begic

Objective: RESTORE II compared in an RCT the impact of a 12-week multidisciplinary rehabilitation program versus standard care (SC) on cardiorespiratory fitness and physical function in patients postupper gastrointestinal (UGI) oncologic surgery. Summary of Background Data: The value of multidisciplinary cancer rehabilitation in UGI cancer survivorship is unclear, with limited high-quality data. Methods: Disease-free patients, ≥3 months post-UGI cancer resection were randomized to SC or RESTORE (physiotherapy-led aerobic and resistance exercise, dietary counselling, and psychosocial support). The primary endpoint was cardiorespiratory fitness (VO ₂ peak). Secondary endpoints included body composition (anthropometry and bioimpedance analysis), muscle strength (hand grip strength and leg-press 1-repetition maximum), functional performance (Short Physical Performance Battery), physical activity (accelerometery), and health-related quality of life (EORTC-QLQ-C30). Assessments were conducted at baseline (T0), postintervention (T1), and 3-month follow-up (T2). Results: Eighty-eight participants were randomized to SC (n=44) or RESTORE (n=44). Median age was 67.5 (range: 43–86) years, n=60 (68.2%) male, and median time postsurgery was 33 (range: 3.5–145) months. VO₂peak remained stable in the SC group. Estimated interaction effects for time ^× group indicate that the mean increases in VO₂peak were greater for RESTORE relative to SC from baseline to T1, by a mean of 1.5 mL/min/kg (95% CI: 0.52–2.48; P -value=0.003), and from baseline to T2 by a mean of 1.23 mL/min/kg (95% CI: 0.18–2.27; P -value=0.02). Secondary endpoints remained stable across treatment arms with no significant differences observed. Conclusion: RESTORE II provides Level I evidence that cardiorespiratory fitness can be targeted and improved in survivors of UGI cancer surgery.

A substantial body of evidence supports the role of exercise in mitigating many effects of cancer and its treatments. However, services for survivors remain scarce, highlighting a significant research-to-practice gap. To address this gap, it is essential to explore strategies that could enhance the dissemination of evidence, supporting the translation of exercise oncology trial findings into clinical practice. To this end, this qualitative study aimed to explore the viewpoints of stakeholders (patients/healthcare professionals (HCPs)/policy makers/researchers) on the dissemination of exercise oncology trials. Stakeholders were invited to take part in a one-to-one semi-structured interview exploring their experiences of and preferences for exercise oncology trial dissemination. Interviews were audio-recorded, transcribed verbatim, and analysed using a thematic approach. Thirty stakeholders were recruited: patients with a history of cancer (n = 14), healthcare professionals (HCPs) (n = 3), researchers (n = 10), and policy makers/healthcare management (n = 3). Median interview length was 14 min and 10 s (range 8 min 16 s to 37 min and 23 s). Three main themes were identified: (i) the need for enhanced dissemination strategies, (ii) engaging stakeholders throughout the study lifespan as key to facilitating effective dissemination, and (iii) tools to support closing the research-to-practice gap. Results indicate that stakeholders want dissemination approaches tailored to the intended audience and presented in formats that are accessible both linguistically and practically, recognising the individuality of each stakeholder group. To support this, three main recommendations were generated: (i) engage all stakeholders throughout the entire research project, from planning to dissemination, to ensure that dissemination avenues are appropriately targeted; (ii) implement a multi-component dissemination strategy that incorporates multiple avenues, blending traditional and innovative approaches to address the priorities of specific stakeholder groups; (iii) adopt multiple communication approaches that extend beyond written format alone and use stakeholder-specific language which is understandable to target audience while maintaining credibility and rigour.

Exercise is an effective intervention at mitigating many of the sequalae of cancer and its treatments. However, a scarcity of exercise services for cancer survivors remains, highlighting a research-to-practice gap. Accordingly, there is considerable rationale to explore strategies to enhance the implementation of exercise oncology trial findings into clinical practice. Dissemination is the active process of spreading research findings to key stakeholders and is crucial to the implementation of evidence base practice. However, little is known regarding the optimal methods of disseminating results of exercise oncology trials. To this end, this project aimed to explore the viewpoints of stakeholders (patients/ health care professionals (HCPs)/ policy makers/ researchers) on the dissemination of exercise oncology trials. Stakeholders were invited to take part in a one-to-one semi-structured interview exploring their experiences of and preferences for exercise oncology trial dissemination. Interviews were audio recorded, transcribed verbatim, and analyzed using a thematic approach. Thirty stakeholders were recruited: patients with a history of cancer (n=14), health care professionals (HCPs) (n=3), researchers (n=10), and policy makers/ health care management (n=3). Median interview length was 14 minutes and 10 seconds (range 8 minutes 16 seconds to 37 minutes and 23 seconds). Three main themes were identified: i) The need for enhanced dissemination strategies, ii) engaging stakeholders throughout the study lifespan is key to facilitating effective dissemination and iii) tools to facilitate closing the research to practice gap. Stakeholders acknowledged that there is limited awareness amongst the public regarding the benefits of exercise across the cancer trajectory, and that accessible and trustworthy information delivered through a variety of mediums to target different stakeholders is required. Stakeholders felt strongly that research outputs need to be targeted to the interests of key stakeholders to aid the integration of evidence into practice, and that buy-in from clinicians is paramount to integrating exercise into usual care. Results of this qualitative study highlight there is a need for more widespread and targeted dissemination of exercise oncology trial results. Stakeholders recommended a comprehensive approach to dissemination to help mitigate the research to practice gap.

Introduction: Public and patient involvement (PPI) may be utilised to improve aspects of trial conduct. This study within a trial (SWAT) aimed to examine if a PPI‐informed participant information leaflet (PIL) could improve recruitment, retention, and quality of decision‐making of an exercise‐based rehabilitation trial (RESTORE II) for upper gastrointestinal (UGI) cancer survivors. Methods: This SWAT was conducted over two phases. Phase 1 applied qualitative methods to develop and refine a PPI‐informed PIL. Phase 2 embedded a randomised controlled double‐blind SWAT within the RESTORE II trial, comparing a standard PIL (PIL A) to the PPI‐informed PIL (PIL B) in terms of recruitment, retention, and quality of decision‐making (Decision Making Questionnaire [DMQ]). Results: Phase 1 recruited 16 PPI members (mean age 67.01 [9.28] years, mostly male [81.25%] and all UGI cancer survivors). Participants reviewed the standard PIL A and made suggestions for improvement, including revisions to the layout, title, text, provision of key information on the first page, and greater emphasis on the potential benefits of participation. This feedback was used to draft the alternative PIL B, which the Phase 1 participants reviewed and refined through minor changes to the appearance, text, and layout. In Phase 2, 307 potential RESTORE II trial participants were randomised to receive either PIL A ( n = 154) or PIL B ( n = 153). The overall recruitment rate was 28.7%. (PIL A 26.6% vs. PIL B 30.7%, OR 1.22 [95% CI 0.74 to 2.01, p = 0.43]), retention was 84.1% (PIL A 85.4% vs. PIL B 83.0%, OR 0.84 [95% CI 0.26 to 2.65, p = 0.760]). No significant difference in mean (SD) DMQ scores was observed: PIL A: 29.1 (4.4) vs. PIL B: 29.1 (5.1) (mean difference 0.03, 95% CI −1.64 to 1.69, p = 0.49). Conclusions: A PPI‐informed PIL did not improve recruitment, retention, or decision‐making for the RESTORE II trial. Patient or Public Contribution: Patients with UGI cancer informed the development of the interventional PIL B. Author P.B. provided input from the patient's perspective throughout the SWAT as a member of the Trial Steering Committee, providing oversight to the SWAT management, and contributed to analysis and the production of this manuscript. Trial Registration: SWAT Registration: The Northern Ireland Hub for Trials Methodology Research, SWAT Store, SWAT 100 https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,914713,en.pdf . Host Trial Registration Clinical Trials. gov https://clinicaltrials.gov/study/NCT03958019 .