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A study investigating whether more regular, individualised dietary counselling with patients and their caregivers can improve quality of life in people with cancer and those looking after them.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001352291
Acronym
PiCNIC2 Trial
Enrollment
32
Registered
2018-08-10
Start date
2018-09-28
Completion date
2019-01-25
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Who is it for? You may be eligible for this study if you are aged over 18, have cancer, are attending the Royal Brisbane and Women's Hospital medical oncology outpatient clinics and have been identified as being at risk of malnutrition. Caregivers of these patients may also be eligible. Study details Participants will be randomised (by chance) into two groups. One group will see a hospital research dietitian for three counselling sessions, two weeks apart (i.e. over four to five weeks). The other group will continue to receive their usual care. Before and after the program, participants will answer a number of questionnaires relating to their quality of life, nutritional status and level of distress. It is hoped this research demonstrates improved quality of life for people with cancer and their caregivers (where available). Additionally, this research hopes to demonstrate the feasibility of the program, and facilitate the implementation of a definitive randomised controlled trial (RCT) in the future.

Interventions

In this two arm randomised controlled trial (RCT), subjects who are randomised to the intervention group will receive an intensive nutrition intervention by an Accredited Practising Dietitian who is highly skilled in cancer care and independent of both the research team and usual care for medical oncology cancer care dietetic services. The intervention provides 2-2.5 hours of dietitian direct contact time over a 4-5-week period, including regular, frequent follow up to monitor, re-enforce and ad

In this two arm randomised controlled trial (RCT), subjects who are randomised to the intervention group will receive an intensive nutrition intervention by an Accredited Practising Dietitian who is highly skilled in cancer care and independent of both the research team and usual care for medical oncology cancer care dietetic services. The intervention provides 2-2.5 hours of dietitian direct contact time over a 4-5-week period, including regular, frequent follow up to monitor, re-enforce and adjust goals, with a focus on including family/carers in the process where applicable. The intervention for this trial is refined based on findings from prior feasibility intervention study. The focus of this intervention is to improve symptoms and quality of life and psychosocial outcomes in patients and caregivers through nutritional counselling, rather than solely achieving sufficient energy/protein intake as per traditional dietary interventions. The intervention will last for 4 weeks and includes the following components: WEEK 1, DAY 1 - Face-to-face counselling over 1-1.5 hrs, to: 1. Assess patient’s nutrition status, nutrition impact symptoms and diet history including any dietary beliefs; 2. Negotiate nutritional goals with patient and caregivers; 3. Answer any nutrition-related questions from patient and family if any; 4. Provide patient and family-centred nutrition counselling supplemented with relevant nutrition education materials; 5. Liaise with multidisciplinary team (MDT) for management of nutrition impact symptoms as required; and 6. Make an appointment for telehealth-based reinforcement counselling. WEEK 3, DAY 1 - Reinforcement counselling face-to-face or via videoconference (telehealth) over 30 minutes, to: 1. Assess patient’s nutrition status, nutrition impact symptoms and diet history; 2. Identify barriers/facilitators to goal achievement and adjust goal if necessary; 3. Provide patient and family-centred nutrition counselling; and 4. Make an appointment for telehealth follow-up. WEEK 5, DAY 1 - Follow-up face-to-face or via videoconference (telehealth) over 30 minutes, to: 1. Assess patient’s nutrition status, nutrition impact symptoms and diet history; 2. Discuss nutritional goal achievement; 3. Identify barriers/facilitator to inform future goal setting and adjust goal if necessary; 4. Provide further patient and family-centred nutrition counselling as required; and 5. Discuss if patient would like ongoing care and refer into usual care as required.

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

PATIENTS 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. CAREGIVERS 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.

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026