ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001352291

Ethics application status

Approved

Date submitted

30/07/2018

Date registered

10/08/2018

Date last updated

21/10/2019

Date data sharing statement initially provided

21/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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.

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PiCNIC2 Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Advanced cancer

Malnutrition

Psychosocial distress

Eating-related distress

Condition category

Condition code

Cancer

Any cancer

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Subjects in the control group will receive usual care. They will be referred to the outpatient dietitian who provides usual care for medical oncology cancer care dietetic services and an appointment is then made to align with next cycle of chemotherapy or within 10 working days from receipt of referral. The initial appointment is 30 minutes which is usually scheduled during their chemotherapy appointment and may not necessarily include family/carers. Based on clinical discretion patients are then reviewed by the usual care dietitian at their next chemotherapy cycle, which is usually in 3-6 weeks’ time and/or via telephone review with a dietetic assistant.

If patients are admitted during the intervention period – the ward dietitian will provide care to the patient whilst they are an inpatient as per current standard care.

Control group

Active

Outcomes

Primary outcome [1]

As this is a pilot RCT, the primary outcome is study feasibility. Feasibility will be assessed as:
- Consent rate (target: equal to or greater than 80%)
-- Reasons for consent failure, collected as an additional optional question during the consent process
- Retention rate (target: equal to or greater than 80% of recruited patients)
- Fidelity to the intervention, measured as:
-- Proportion of patients attending all three (3) dietitian appointments;
-- Proportion of caregivers (where available) attending all three (3) dietitian appointments;
-- Adherence of appointment dates to specified study timeframe (i.e. Week 1, Week 3, Week 5);
-- Proportion of patients with a document treatment goal, retrospectively collected from the medical chart by the RA.
- Proportion of patients with and without a caregiver, collected by participant report during the eligibility screening process using a standardised tool.
- Acceptability of each survey listed in the secondary outcomes to patients and/or caregivers, measured as a two question likert scale (0-10) to assess (a) ease of completing each survey, and (b) relevancy of the questions (target: score of greater than 5 for both ease and relevancy).

Timepoint [1]

Feasibility will be determined at trial completion (i.e. following post-intervention (week 6) data collection for the last patient), including collection of documented treatment goal.

Secondary outcome [1]

Change in patient Quality of life, measured using The functional Assessment of Anorexia/Cachexia Therapy tool (39 items)

Timepoint [1]