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Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC. The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition. A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy. ClinicalTrials.gov NCT06582498.

ObjectivesThere are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument.DesignA scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged.SettingFour countries (Spain, UK, USA and Portugal).ParticipantsExperts working in a cancer-related health profession or cancer-related research were recruited.Main outcome measuresItems were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting.ResultsA total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress.ConclusionsWe identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.