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STRONG for Surgery & Strong for Life — against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery — a protocol for an RCT with nested interview study (STRONG-Cancer)

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Background: There is a large unused potential for risk reduction in the preoperative period via effective lifestyle intervention targeting co-existing risky lifestyles: Smoking, malNutrition, obesity, risky Alcohol intake and insufficient Physical activity (SNAP). This trial compares the efficacy of the integrated STRONG programme with standard care on preoperative risk reduction and secondly on SNAP factor improvement and frailty, postoperative complications and quality of life. A nested interview study explores the patient preferences and the multi-perspective view of patients, relatives and health professionals. Methods: In total, 42 surgical patients with ≥1 SNAP factor are allocated to individually tailored STRONG programme or usual care during adjuvant chemotherapy prior to radical bladder cancer surgery. The STRONG programme has ≥6 weekly sessions with patient education, motivational and pharmaceutical support. It is based on intensive smoking and alcohol cessation interventions reporting perioperative quit rates > 50%. Surgical risk reduction is measured as ≥1 step for 1 or more risky lifestyles on the ASA-score, secondly as having no risky SNAP factors, and as any SNAP improvement. The outcomes are validated by measurements and biomarkers. Postoperative complications are categorised according to the Clavien-Dindo classification. Health-related quality of life is measured by EQ-5D. The patients are followed up after 6 weeks at surgery and 6 weeks and 6 months postoperatively. A representative sample of the participants, their relatives and the clinical staff are interviewed until data saturation. Transcription, triangulated analyses and data management are conducted using NVivo computer software. Discussion: The surgical agenda is characterised by fixed dates for surgery focusing on clear risk reduction within a short time. This requires a clinical useful lifestyle intervention programme with a high effect and coverage as well as containing all SNAP factors and tailored to individual needs. The STRONG programme seems to meet these requirements. After development in multi-professional collaboration, STRONG is delivered by a specially trained nurse as part of the surgical patient journey. Overall, this study will bring important new knowledge about risk reduction in a frail patient group undergoing major cancer surgery. Trial registration: Registration at www.clintrials.gov (NCT04088968) The manuscript form from https://trialsjournal.biomedcentral.com/bmc/journal and the SPIRIT guidelines are followed.

OriginalsprogEngelsk
Artikelnummer333
TidsskriftTrials
Vol/bind23
Udgave nummer1
Sider (fra-til)333
ISSN1745-6215
DOI
StatusUdgivet - 21 apr. 2022

Bibliografisk note

Funding Information:
The Danish Cancer Society (R223-A13094): 2.9 mill. DKK (part of the COMPAS Project receiving 20 mill DKK); Novo Nordic Foundation (NNF19OC0058924): 0.6 mill DKK; the Parker Institute, Bispebjerg-Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

Funding Information:
HT and SVL conceived the study and drafted the manuscript. HT, LNL, UNJ, HP and SVL designed the study. LNL, UNJ, HP and SVL are local investigators at the participating centre. The study is supervised and coordinated by HT, UNJ, HP and SVL. HT and SVL are responsible for the accurate execution of the study. All authors approved the final manuscript. The funders play no role in the conceptualism, the design, collection, management, analyses and interpretation of data, writing the report for publications or have ultimate authority over any of these activities. The Danish Cancer Society (R223-A13094): 2.9 mill. DKK (part of the COMPAS Project receiving 20 mill DKK); Novo Nordic Foundation (NNF19OC0058924): 0.6 mill DKK; the Parker Institute, Bispebjerg-Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). The final trial data for this protocol can be supplied on request.

Publisher Copyright:
© 2022, The Author(s).

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