Aims: To explore feasibility and preliminary outcomes of a randomised controlled trial, using a family-centred, psychosocial-based, nutrition intervention in patients with advanced cancer identified at risk of malnutrition.
Methods: Pilot randomised controlled multicentre trial in Australia and Hong Kong. Patients with or without family caregivers were randomised to receive usual care or intensive nutrition counselling consisting of three dietitian appointments over a 4-6-week period. The aim of the intervention was to address nutrition impact symptoms, food or eating-related psychosocial concerns and set appropriate nutritional goals in conjunction with the patient and carer. Feasibility assessment included recruitment, consent rate, retention rate, and assessment tool acceptability. Validated nutritional and quality of life self-reported measures were used to collect outcomes at baseline and on conclusion of the intervention.
Results: Seventy-four patients and 54 family caregivers participated in the study, with 34 patients randomised to the intervention and 40 to usual care. Recruitment rates were between 7-15%, with consent rates of 44% in patients and 55% in caregivers. Retention rates were 82% (Australia) and 62% (Hong Kong), however approximately only half of all participants returned the outcome assessment forms. Acceptability of the assessment tools (on a 10-point scale) ranged from 6.28-7.99 for patients and 5.18-8.55 in carers.
Patient outcome data were promising for those receiving the intervention, particularly showing improvements in eating-related distress (p=0.046 in the Australian data; p=0.07 in the Hong Kong data), eating-related enjoyment (p=0.024, Hong Kong data) and quality of life (p=0.045, Australian data). Energy and protein intake also increased in a clinically meaningful way. However, caregiver data showed little change.
Conclusions: Despite difficulties with recruitment, the intervention demonstrates good potential to have positive effects on patients’ eating-related distress and quality of life. The results of this trial warrant a larger and fully-powered trial to ascertain the effectiveness of this intervention.