The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000027213
Ethics application status
Approved
Date submitted
17/11/2017
Date registered
12/01/2018
Date last updated
16/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising care: a program supporting women with metastatic breast cancer to be active and eat well
Scientific title
Optimising care: a pilot study evaluating the feasibility, safety and preliminary efficacy of an exercise and dietary intervention for women with metastatic breast cancer
Secondary ID [1] 292240 0
NBCF: PS-17-051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 303742 0
Condition category
Condition code
Cancer 303114 303114 0 0
Breast
Diet and Nutrition 303115 303115 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a 16-week exercise and dietary program, tailored to their individual needs.

The exercise program will focus on increasing aerobic-based and resistance-based exercise. Women will have eight supervised exercise sessions with an accredited exercise physiologist (AEP) based at their local gymnasium, their home or another location convenient to the participant. The target dose of exercise will be for participants to complete 150 minutes of moderate intensity activity per week, including two sessions of resistance exercises. The data collected as part of the baseline assessment will be used to inform and guide the initial exercise prescription. The exercises will be progressed and adapted as appropriate, with a tapering of frequency of contacts with the AEP over the course of the program.

The dietary program will focus on ensuring adequate consumption of protein, increasing diet quality and managing nutritional impact symptoms (e.g. nausea/vomiting, constipation/diarrhoea), which will be common in women undergoing chemotherapy. Women will have an initial one-on-one face-to-face session with an accredited practising dietitian (APD), followed by seven telephone sessions. The dietitian will also discuss participants' goals and preferences in relation to dietary intake and will use this to tailor the content and focus of sessions.

Women will complete three study assessments over a 10-month period: baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention) and 10-months (T3/6-months post-intervention).
Intervention code [1] 298402 0
Lifestyle
Intervention code [2] 298403 0
Behaviour
Comparator / control treatment
Single-arm pilot study (all participants receive intervention)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302493 0
Feasibility:
i) participant reach as measured by consent rates (#consenting / # interested and eligible / 100%) and representativeness (comparing basic characteristics of participants to non-participants);
ii) intervention adherence (#completed sessions / #scheduled sessions, x100%)
iii) compliance (prescribed program compared with completed program each week);
iv) participant retention (#completed follow-up testing /#completed baseline testing x100%);
v) participant satisfaction (participant satisfaction survey, semi-structured interview)
Timepoint [1] 302493 0
i) Participant reach: baseline (T1/pre-intervention)
ii) Intervention adherence
iii) Compliance: 16-weeks (T2/end-of-intervention)
iv) Participant retention: 16-weeks (T2, end-of-intervention), 10-months (T3/6-months post-intervention)
v) Participant satisfaction:: 16-weeks (T2/end-of-intervention)
Primary outcome [2] 302494 0
Safety: incidence and severity of adverse events. Adverse events will be categorised using the CTC-AE version 4 (Common Terminology Criteria for Adverse Events) criteria. Adverse events will also be categorised according to whether they were related to the intervention. Examples of adverse events that could relate to participation in the program include (but are not limited to): fall, sprain, fracture, injury, episode of low blood sugar, strain, pull, tear of muscle or bone, or any other adverse events the participant considers as being a direct result of the program.

The study will be deemed safe if the proportion of participants reporting grade 3-5 adverse events (as measured by the standard CTC-AE version 4) related to the intervention is less than 10%.
Timepoint [2] 302494 0
throughout intervention; 16-weeks (T2/end-of-intervention); 10-months (T3/6-months post-intervention)
Secondary outcome [1] 336187 0
Quality of life as measured by:
i) Functional Assessment of Cancer Therapy – Breast (FACT+4)
ii) European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30)
Timepoint [1] 336187 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [2] 336188 0
Body composition: Dual-energy X-ray Absorptiometry (DEXA)
Timepoint [2] 336188 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [3] 336217 0
Hand grip strength (Smedley handheld dynamometer)
Timepoint [3] 336217 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [4] 336220 0
Fitness: 6 minute walk test
Timepoint [4] 336220 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [5] 336221 0
Nutritional status: Scored Patient-Generated Subjective Global Assessment (Scored PG-SGA)
Timepoint [5] 336221 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [6] 336222 0
Fatigue: Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue)
Timepoint [6] 336222 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [7] 336223 0
Cancer and treatment-related symptoms: symptom scales and items from the EORTC QLQ-C30 (nausea, pain, dyspnoea, insomnia, appetite loss, constipation and diarrhoea)
Timepoint [7] 336223 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [8] 336224 0
Psychosocial well-being: Hospital Anxiety and Depression Scale (HADS)
Timepoint [8] 336224 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [9] 336225 0
Physical activity and sedentary time: activPAL3 inclinometer; Actigraph GT3X+ accelerometer
Timepoint [9] 336225 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [10] 337686 0
Dietary intake: Australian Eating Survey (AES)
Timepoint [10] 337686 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [11] 340898 0
Body composition: CT scan at lumbar spine 3
Timepoint [11] 340898 0
end of study
Secondary outcome [12] 340899 0
Mid-upper arm muscle area: skin-fold caliper, assessor measured
Timepoint [12] 340899 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [13] 340900 0
Upper body endurance (YMCA benchpress)
Timepoint [13] 340900 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [14] 340901 0
Lower extremity physical performance status (Short Physical Performance Battery)
Timepoint [14] 340901 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [15] 340904 0
Fatigue: symptom scales and items from the EORTC QLQ-C30
Timepoint [15] 340904 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)
Secondary outcome [16] 340905 0
Stress: 10-item Perceived Stress Scale
Timepoint [16] 340905 0
baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention), 10-months (T3/6-months post-intervention)

Eligibility
Key inclusion criteria
- Diagnosis of metastatic breast cancer in the previous 5 years, or progression of metastatic disease over the last 2 years
- Estimated prognosis of 12 months or more as deemed by the treating oncologist
- ECOG performance status 0 – 2 (i.e. ‘fully active, able to carry on all pre-disease performance’ through to ‘ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours’)
- Deemed otherwise suitable for participation in an exercise and dietary intervention by the treating oncologist (e.g. no significant comorbidities such as unstable angina or significant psychiatric conditions)
- Reside within the greater Brisbane area and able to travel for assessments
- Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant
- Insufficient English to complete assessments and participate in the intervention
- Unable to travel to Brisbane to complete study assessments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Feasibility, safety and acceptability will be reported descriptively. The feasibility of the intervention will be assessed by computing retention, adherence and compliance rates and deemed acceptable when at or above 75%. The study will be deemed safe if the proportion of participants reporting grade 3-5 adverse events (as measured by the standard CTC-AE version 4) related to the intervention is less than 10%.

Changes in secondary outcomes over time will be analysed using linear mixed models, with all evaluable cases analysed. Estimates of mean changes (and the variance) for these outcomes will be used to inform effect sizes for future trials. Statistical significance will be set at p<0.05. Where available, mean changes (and confidence intervals) in outcomes will be compared to established minimum clinically important differences

The sample of women recruited will be heterogeneous in terms of disease burden, treatment and symptoms. Therefore, to inform the larger-scale trial, we will explore predictors of study participation, intervention adherence and drop out, such as site(s) and burden (number of sites/volume) of metastatic disease, current treatments, breast cancer subtype (ER+/HR versus other), performance status etc. We will also explore individual variation in changes in patient-relevant outcomes to examine whether there are particular subgroups of women for whom the intervention appeared to be more or less beneficial. We will also explore trajectories of outcomes through a subgroup analysis and categorise participants according to trajectories (e.g. improvers, no change, decliners).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8403 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 8404 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 8405 0
Mater Private Hospital - South Brisbane
Recruitment hospital [4] 8406 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 8407 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [6] 8408 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [7] 8409 0
Icon Cancer Care Chermside - Chermside
Recruitment postcode(s) [1] 16478 0
4029 - Herston
Recruitment postcode(s) [2] 16479 0
4101 - South Brisbane
Recruitment postcode(s) [3] 18008 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 18009 0
4066 - Auchenflower
Recruitment postcode(s) [5] 18010 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 296787 0
Charities/Societies/Foundations
Name [1] 296787 0
National Breast Cancer Foundation (NBCF)
Address [1] 296787 0
GPO Box 4126
Sydney
NSW 2001
Country [1] 296787 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Public Health
The University of Queensland
Herston Road
Herston QLD 4072
Country
Australia
Secondary sponsor category [1] 295770 0
None
Name [1] 295770 0
Address [1] 295770 0
Country [1] 295770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298011 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 298011 0
Office of the Human Research Ethics Committee
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Butterfield St
Herston Qld 4029
Ethics committee country [1] 298011 0
Australia
Date submitted for ethics approval [1] 298011 0
31/07/2017
Approval date [1] 298011 0
15/11/2017
Ethics approval number [1] 298011 0
Ethics committee name [2] 298023 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 298023 0
Research & Innovation Division
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia Qld 4072
Ethics committee country [2] 298023 0
Australia
Date submitted for ethics approval [2] 298023 0
17/11/2017
Approval date [2] 298023 0
30/11/2017
Ethics approval number [2] 298023 0
2017001817

Summary
Brief summary
The aim of this study is to assess the feasibility and safety of an individually-tailored exercise and dietary program for women with metastatic breast cancer (MBC) and provide preliminary evidence on changes in patient-relevant outcomes such as quality of life.

Who is it for?
You may be eligible to join this study if you are a woman aged 18 years or over and have a diagnosis of metastatic breast cancer in the previous 5 years, or progression of metastatic disease over the last 2 years.

Study details
All women will receive a 16-week exercise and dietary program, individually-tailored based on their baseline assessment, tumour burden and treatment. The program will focus on increasing exercise (aerobic- and resistance-based), improving diet quality and managing nutritional symptoms (e.g., nausea/vomiting, constipation/diarrhoea), to improve (or attenuate declines in) quality of life, lean body mass and physical function. Data will be collected at baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention) and 10-months (T3/six-months post-intervention).

We hypothesise that a 16-week exercise and dietary program will be feasible and safe for women with MBC and will improve (or reduce declines in) patient-relevant outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75726 0
A/Prof Marina Reeves
Address 75726 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 75726 0
Australia
Phone 75726 0
+61 7 3346 4692
Fax 75726 0
+61 7 3365 5540
Email 75726 0
m.reeves@sph.uq.edu.au
Contact person for public queries
Name 75727 0
A/Prof Marina Reeves
Address 75727 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 75727 0
Australia
Phone 75727 0
+61 7 3346 4692
Fax 75727 0
+61 7 3365 5540
Email 75727 0
m.reeves@sph.uq.edu.au
Contact person for scientific queries
Name 75728 0
A/Prof Marina Reeves
Address 75728 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 75728 0
Australia
Phone 75728 0
+61 7 3346 4692
Fax 75728 0
+61 7 3365 5540
Email 75728 0
m.reeves@sph.uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results