The effects of a family-centered psychosocial-based nutrition intervention in patients with advanced cancer: the PiCNIC2 pilot randomised controlled trial
Authors: Molassiotis Alex , Brown Teresa , Cheng Hui Lin , Byrnes Angela , Chan Raymond Javan , Wyld David , Eastgate Melissa , Yates Patsy , Marshall Andrea P , Fichera Rebecca , Isenring Liz , To Ki Fung , Ko Po Shan , Lam Wang , Lam Yuk Fong , Au Lai Fan , Lo Raymond See-kit 
Published: January 2021

Abstract
Background
Malnutrition in advanced cancer patients is common but limited and inconclusive data exists on the effectiveness of nutrition interventions. Feasibility and acceptability of a novel family-based nutritional psychosocial intervention were established recently. The aims of this present study were to assess the feasibility of undertaking a randomised controlled trial of the latter intervention, to pilot test outcome measures and to explore preliminary outcomes.

Methods
Pilot randomised controlled trial recruiting advanced cancer patients and family caregivers in Australia and Hong Kong. Participants were randomised and assigned to one of two groups, either a family-centered nutritional intervention or the control group receiving usual care only. The intervention provided 2–3 h of direct dietitian contact time with patients and family members over a 4–6-week period. During the intervention, issues with nutrition impact symptoms and food or eating-related psychosocial concerns were addressed through nutrition counselling, with a focus on improving nutrition-related communication between the dyads and setting nutritional goals. Feasibility assessment included recruitment, consent rate, retention rate, and acceptability of assessment tools. Validated nutritional and quality of life self-reported measures were used to collect patient and caregiver outcome data, including the 3-day food diary, the Patient-Generated Subjective Global Assessment Short Form, the Functional Assessment Anorexia/Cachexia scale, Eating-related Distress or Enjoyment, and measures of self-efficacy, carers’ distress, anxiety and depression.

Results
Seventy-four patients and 54 family caregivers participated in the study. Recruitment was challenging, and for every patient agreeing to participate, 14–31 patients had to be screened. The consent rate was 44% in patients and 55% in caregivers. Only half the participants completed the trial’s final assessment. The data showed promise for some patient outcomes in the intervention group, particularly with 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. Caregiver data on eating-related distress, anxiety, depression and caregiving burden, however, showed little or no change.

Conclusions
Despite challenges with participant recruitment, the intervention demonstrates good potential to have positive effects on patients’ nutritional status and eating-related distress. The results of this trial warrant a larger and fully-powered trial to ascertain the effectiveness of this intervention.

Trial registration
The trial was registered with the Australian & New Zealand Clinical Trials Registry, registration number ACTRN12618001352291.