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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] 295618 0
None
Universal Trial Number (UTN)
Trial acronym
PiCNIC2 Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer 308943 0
Malnutrition 308944 0
Psychosocial distress 308945 0
Eating-related distress 308946 0
Condition category
Condition code
Cancer 307844 307844 0 0
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] 301923 0
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] 306922 0
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] 306922 0
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] 350339 0
Change in patient Quality of life, measured using The functional Assessment of Anorexia/Cachexia Therapy tool (39 items)
Timepoint [1] 350339 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [2] 350340 0
Change in patient nutritional status, measured using the Patient-Generated Subjective Global Assessment Short Form (4-item)
Timepoint [2] 350340 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [3] 350341 0
Change in patient weight, measured using a single set of digital scales
Timepoint [3] 350341 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [4] 350342 0
Change in patient body composition, measured using a single set of digital scales with bioelectric impedance analysis (BIA) capacity
Timepoint [4] 350342 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [5] 350343 0
Change in patient eating-related distress, measured using two single-item measures, including:
- One question (unvalidated) about satisfaction and enjoyment of food (measured on a 0-10 likert scale)
- One question (unvalidated) about distress level related to diet, based on the concept of diet-related distress from the Symptom Assessment Scale (measured on a 0-10 likert scale)
Timepoint [5] 350343 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [6] 350344 0
Change in caregiver anxiety and depression, measured using the Hospital Anxiety & Depression Scale (14 items)
Timepoint [6] 350344 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [7] 350345 0
Change in caregiver self-efficacy, measured using the Caregiver Self-efficacy Scale (21 items)
Timepoint [7] 350345 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [8] 350346 0
Change in caregiver distress, measured using Caregiver Distress Checklist (18 items)
Timepoint [8] 350346 0
Baseline (Week 0) and post-intervention (Week 6)
Secondary outcome [9] 350347 0
Change in caregiver eating-related distress, measured using:
- The Eating-related Distress Scale (19 items)
- One question (unvalidated) about distress level related to diet, based on the concept of diet-related distress from the Symptom Assessment Scale (measured on a 0-10 likert scale)
Timepoint [9] 350347 0
Baseline (Week 0) and post-intervention (Week 6)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be undertaken by the principal investigator using sequentially numbered sealed opaque envelopes. Randomised sequences of block sizes (two and four) will be used to minimise the ability to predict the next assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated in advance using a computer-generated randomisation program. To ensure equal distributions of participants between the two groups with the small sample size in this study, block randomisation procedures will be followed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered to the IBM SPSS version 21.0. Descriptive statistics will be used to describe the sample profiles. Non-parametric tests will be used to conduct inferential analysis due to the small sample size. Differences in outcomes at two time points across 2 groups will be compared.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
28/09/2018
Date of last participant enrolment
Anticipated
Actual
25/01/2019
Date of last data collection
Anticipated
Actual
10/04/2019
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11534 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 23561 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 300197 0
Charities/Societies/Foundations
Name [1] 300197 0
RBWH Foundation
Country [1] 300197 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Department of Nutrition and Dietetics
Lvl 2, Dr James Mayne Bldg
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 299702 0
None
Name [1] 299702 0
Address [1] 299702 0
Country [1] 299702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301023 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 301023 0
Lower ground floor, Executive Offices
Dr James Mayne Bldg
Butterfield Street, Herston QLD 4029
Ethics committee country [1] 301023 0
Australia
Date submitted for ethics approval [1] 301023 0
30/07/2018
Approval date [1] 301023 0
10/09/2018
Ethics approval number [1] 301023 0
HREC/2018/QRBW/43155

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85626 0
Dr Teresa Brown
Address 85626 0
Department of Nutrition and Dietetics
Lvl 2, Dr James Mayne Bldg, Royal Brisbane and Women's Hospital
Herston, Qld, 4029
Country 85626 0
Australia
Phone 85626 0
+61 7 3646 8268
Fax 85626 0
Email 85626 0
[email protected]
Contact person for public queries
Name 85627 0
Teresa Brown
Address 85627 0
Department of Nutrition and Dietetics
Lvl 2, Dr James Mayne Bldg, Royal Brisbane and Women's Hospital
Herston, Qld, 4029
Country 85627 0
Australia
Phone 85627 0
+61 7 3646 8268
Fax 85627 0
Email 85627 0
[email protected]
Contact person for scientific queries
Name 85628 0
Teresa Brown
Address 85628 0
Department of Nutrition and Dietetics
Lvl 2, Dr James Mayne Bldg, Royal Brisbane and Women's Hospital
Herston, Qld, 4029
Country 85628 0
Australia
Phone 85628 0
+61 7 3646 8268
Fax 85628 0
Email 85628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval has not been sought to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.