A PatIent-family-Centered intervention to promote Nutrition In advanced Cancer patients: a pilot randomised controlled trial

Royal Brisbane and Women's Hospital0 sites32 target enrollmentAugust 10, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2018

End Date

April 10, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Will be (1\) aged 18 years or older, (2\) diagnosed with advanced non curative solid tumours (\+/\- metastatic disease), (3\) with life expectancy of at least 6 months at discretion of the treating medical oncologist, (4\) at risk of malnutrition from any cause (score equal to or greater than 2 as assessed by the Malnutrition Screening Tool), (5\) capable of oral food intake, (6\) Eastern Cooperative Oncology Group (ECOG) score 0\-2, (7\) living at home with or without a carer, and (8\) able to communicate in English and fill in the study questionnaires with or without assistance.
•Will be (1\) aged 18 years or older, (2\) a family member (e.g. husband/wife, children, relatives), or someone who is designated to take care of the patient who visits for at least one hour per day on most days, (3\) able and willing to provide regular assistance with meals and/or nutritional support at home (ideally being present for 2 or more meals a day), and (4\) able to communicate in English and fill in the study questionnaires.

•Patients will be excluded if they are (1\) Completely 'nil by mouth' or participating in other types of nutritional intervention research. (2\) unable to give informed consent and communicate with the study team. (3\) currently under the active care of a dietitian with a follow up appointment scheduled.
•In this pilot study, patients will not be excluded if they do not have an identified caregiver participating in the study, as these patients are expected to also benefit from the intervention in the feasibility trial.