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Trial registered on ANZCTR


Registration number
ACTRN12619000631101
Ethics application status
Approved
Date submitted
15/04/2019
Date registered
29/04/2019
Date last updated
2/06/2020
Date data sharing statement initially provided
29/04/2019
Date results information initially provided
2/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
ENABLE: ENhAncing lifestyle Behaviours in endometriaL cancEr
Scientific title
ENABLE: ENhAncing lifestyle Behaviours in endometriaL cancEr: a pilot randomised controlled trial regarding the feasibility of a multi-disciplinary lifestyle, education and social support program.
Secondary ID [1] 297718 0
Peter Mac Foundation Protocol Number #1812
Universal Trial Number (UTN)
U1111-1230-0910
Trial acronym
ENABLE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 312038 0
Condition category
Condition code
Cancer 310602 310602 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supportive care intervention of social support and lifestyle education (nutrition and physical activity (PA)) with behavior change support.
In addition to usual care, women randomised to the intervention group will receive an eight-week multi-disciplinary program to improve lifestyle behaviours (nutrition and physical activity) coupled with social support and behaviour change techniques. The initial multi-disciplinary session (up to 1.5 hours duration) will be conducted as an individual face-to-face session involving all three clinicians at Peter MacCallum Cancer Centre. Subsequent weekly individual follow-up (20-30 minutes duration) will be completed via telehealth (or face-to face if preferred by participants). All intervention sessions will be scripted to ensure a standardised content is covered for all intervention group participants.

Each intervention session will include aspects of social support, lifestyle education and behaviour change. The social worker will work with participants to identify issues which may act as barriers to participants being able to make changes to their current nutrition and physical activity behaviours. This may involve referral to support services within the community. The dietitian and physiotherapist will provide education regarding good nutrition and increasing physical activity which is individualized and based on baseline assessment findings and patient preferences. It is anticipated that many participants will choose walking as their preferred form of physical activity. Participants will be encouraged to exercise at a moderate intensity level, commencing at a minimum of 10 minute bouts and gradually increasing to meet the physical activity recommendations of 150 minutes of moderate intensity aerobic exercise per week. To increase social support for changing lifestyle behaviours a family member or friend of the intervention group participant will also be encouraged to attend face-to-face and telehealth consultations and participate in the PA program where possible.
Recommended nutrition, weight management and PA and associated benefits for people with endometrial cancer will be discussed and standard written educational material, developed by the Peter MacCallum Cancer Centre, will be provided. Participants will work with the health professionals to establish a home-based PA program and develop individualised, patient-centred nutrition and PA-related short and longer-term goals. In addition to goal setting, behaviour change strategies will include action planning, barrier identification/problem solving, self-monitoring of behavioural outcomes (using an activity monitor and diary), relapse prevention/coping planning and providing feedback regarding performance.
Intervention code [1] 313955 0
Lifestyle
Intervention code [2] 313956 0
Behaviour
Intervention code [3] 313957 0
Rehabilitation
Comparator / control treatment
Usual care at either site (Peter MacCallum Cancer Centre or the Royal Womens Hospital) - which does not currently involve routine referral to social work, physiotherapy or nutrition services..
Control group
Active

Outcomes
Primary outcome [1] 319450 0
The primary objective of this pilot RCT is to determine the feasibility of recruitment (recruitment rate) and the reasons for trial ineligibility, in order to inform a definitive RCT. Feasibility is a composite outcome.

Additional feasibility outcomes are:
a. the proportion of eligible participants who provide consent (assessed from trial screening database)
b. the reasons for declining participation (assessed from trial screening database)
c, participant retention at each follow-up assessment (assessed from trial outcome database)
d. the proportion of complete outcome assessments at each time point (assessed from trial outcome database)
e. trial acceptability to a subgroup of participants from each group and the intervention clinicians (semi-structured individual telephone interviews will be performed at trial completion)
f. for intervention group participants only, the proportion using the trial diary to record details of nutrition and physical activity (assessed by return of participant diaries)
g. for intervention group participants only, the number, timing and duration of intervention sessions (both face-to-face and telehealth consultations, obtained from trial intervention database)
h. for intervention group participants only, intervention adherence (either face-to-face or via telehealth video or telephone, measured by the number of scheduled intervention sessions attended)
i. for all participants, the number of external referrals made for social support (obtained from medical records and the trial intervention database).
Timepoint [1] 319450 0
Feasibility: assessed at completion of data collection.
Primary outcome [2] 319770 0
Safety: the number of adverse events related to the trial intervention (applies to intervention group participants only) and outcome assessments (applies to all participants combined). These will be assessed by patient self-report and medical records.
Serious adverse events include those that: result in death, are life threatening, require hospitalisation or prolongation of existing hospitalisation or result in disability or incapacity.
Minor adverse events include: falls not resulting in injury, severe breathlessness, new or progressive pain, neurological deficits, altered mental status, palpitations and progressive fatigue.
Timepoint [2] 319770 0
Safety: for all participants this will be assessed at baseline, 9-week and 3-month follow-up assessments. In addition this will be assessed during the 7 weeks of weekly follow-up consultations with intervention group participants.
Secondary outcome [1] 368239 0
Health related Quality of Life (HRQoL): Functional Assessment of Cancer Therapy - General (FACT-G)
Timepoint [1] 368239 0
Baseline, 9 weeks post baseline, 3 months post baseline
Secondary outcome [2] 369463 0
Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue Subscale
Timepoint [2] 369463 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [3] 369464 0
Cancer Rehabilitation Evaluation System (CARES)
Timepoint [3] 369464 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [4] 369465 0
Nutritional status assessed using the Patient Generated-Subjective Global Assessment (PG-SGA)
Timepoint [4] 369465 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [5] 369466 0
Eating behaviours assessed by the Rapid eating assessment for patients (REAP)
Timepoint [5] 369466 0
Baseline, 9 weeks and 3 months
Secondary outcome [6] 369467 0
International Physical Activity Questionnaire-Short form (IPAQ-SF)
Timepoint [6] 369467 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [7] 369468 0
Physical Activity Assessment Inventory (PAAI)
Timepoint [7] 369468 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [8] 369469 0
Body composition (fat-free mass index) using bioimpedance analysis
Timepoint [8] 369469 0
Baseline, 9 weeks and 3 months post baseline
Secondary outcome [9] 369470 0
Physical activity levels (objective assessment using 7-days of accelerometry)
Timepoint [9] 369470 0
Baseline, 9 weeks and 3 months post baseline

Eligibility
Key inclusion criteria
1. Women with a histologically confirmed diagnosis of endometrial cancer (EC) following surgery and scheduled for or recently commenced adjuvant therapy (brachytherapy, radiotherapy, chemotherapy or any combination of these treatments).
2. Age 18 years or above at screening
3. Have provided written informed consent for the trial
4. Able to read and write English
5. ECOG performance status of 0-2
6. Available for follow up
7. Life expectancy greater than 3 months
8. Able to access telehealth for telephone or video consultations
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than two weeks post commencement of adjuvant therapy
2. Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial
3. Concurrent, actively treated other malignancy or history of other malignancy treated within the past year
4. Stage 4 or recurrent disease
5. Comorbidities preventing participation in an unsupervised walking program
6. Unable to access telehealth for video or telephone consultations
7. Met PA guidelines for the past month

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 will be concealed prior to randomisation by the use of the module within the REDCap database to perform randomisation. The next treatment to be assigned will not be known by any person prior to eligibility criteria being established and the intention to randomise the patient following baseline assessment being declared.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated by a statistician who is independent of the trial, the database administrator will upload the randomisation schedule and randomisation will be implemented through the module within the trial REDCap database. Confirmation of registration/randomisation will be provided electronically as well as by a unique patient identification number for the patient and the assigned randomisation arm. Randomisation will be stratified by treatment type.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The group allocation ratio will be 2:1 (intervention group:usual care)
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot feasibility study with a pragmatic sample size of 42.
Quantitative analyses:
Descriptive statistics (including counts and percentages for nominal and crude-scale ordinal (<10 levels) valued variables; and means and standard deviations or medians and interquartile ranges, as appropriate, for continuous valued variables) will be used to summarise patient demographic and clinical characteristics. Descriptive statistics will also be used to summarise operational data on the use of participant diaries, the number, timing and duration of intervention sessions, and the number of external referrals.

Primary feasibility outcomes:
Recruitment data will be summarised using a rate and 95% confidence interval using the Poisson distribution. Compliance with assessments, as well as adherence and retention data will be summarised using a proportion and 95% confidence interval; the latter will be estimated using the Wilson method.

Safety outcomes:
Counts and percentages will be used to summarise data on adverse events.

Efficacy outcomes:
Counts and percentages will be used to summarise missing data, including missing items and forms for patient-reported outcome measures. Patient-reported outcome measures will be scored according to author guidelines. Means, standard deviations and ranges will be used to summarise continuous outcomes at each time-point by trial arm. Counts and percentages will be used to summarise binary outcomes at each time-point by trial arm.

Analysis of continuous outcomes will be carried out by fitting a linear mixed model to each outcome separately using the ‘lme4’ package. Models will include fixed effects for trial arm, time and a trial arm-by-time interaction, as well as a random participant effect. Baseline assessment will be included as a covariate. Differences between trial arms at post-baseline assessments will be calculated from these models. Pearson’s chi squared (or Fisher’s exact) tests will be used to analyse trial arm differences in binary outcomes at post-baseline assessments.

Qualitative outcomes:
Semi-structured interview data will be transcribed and a sample of the transcripts will be cross-checked by a second researcher for accuracy. Data will be analysed using conventional content analysis. Line by line coding will be conducted by one of the researchers, this may be done using NVivo version 12 software and a summary of arising themes will be derived. A second independent researcher will co-code a proportion of the data. Disagreements in coding will be discussed and a third researcher will resolve these when consensus is unable to be reached.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment has been ceased from 24.3.20 due to restrictions on face-to-face contact and continuation of recruitment to research projects during the COVID-19 pandemic.
Recruitment was planned to cease by 30.3.20 and the target sample size was not reached due to participant recruitment difficulties.
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)
VIC
Recruitment hospital [1] 13409 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 13410 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 26011 0
3000 - Melbourne
Recruitment postcode(s) [2] 26012 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302245 0
Charities/Societies/Foundations
Name [1] 302245 0
Peter Mac Foundation
Address [1] 302245 0
Ground Floor
305 Grattan Street
Melbourne VIC 3000
Country [1] 302245 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 302101 0
None
Name [1] 302101 0
Address [1] 302101 0
Country [1] 302101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302922 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 302922 0
305 Grattan Street
Melbourne, VIC
3000
Ethics committee country [1] 302922 0
Australia
Date submitted for ethics approval [1] 302922 0
01/03/2019
Approval date [1] 302922 0
14/03/2019
Ethics approval number [1] 302922 0
HREC/48033/PMCC-2019

Summary
Brief summary
This study will evaluate the feasibility of a multi-disciplinary program of lifestyle education (good nutrition and physical activity) and social support for women with endometrial cancer

Who is it for?
You may be eligible to join this study if you are a woman aged 18 and above, have a histologically confirmed diagnosis of endometrial cancer following surgery and are scheduled for or have recently commenced any type of adjuvant therapy (such as brachytherapy, chemotherapy or radiotherapy) at Peter MacCallum Cancer Centre (Melbourne).

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive usual care at their treating hospital which does not routinely involve referral to social work, physiotherapy or nutrition services. Participants in the other group will receive a weekly multi-disciplinary program of social support, lifestyle education (regarding nutrition and physical activity) and behavioural change support for 8 weeks provided by a multi-disciplinary team including a dietician, physiotherapist and social worker. The one-on-one sessions will cover education on diet, physical activity, weight management, support to change dietary and physical activity behaviours and social support. The first session is conducted face-to-face at the Peter MacCallum Cancer Centre with weekly follow-up sessions for an additional seven weeks (conducted remotely by video or telephone).

The findings from this research will establish how feasible it is to provide this multi-disciplinary service to those with endometrial cancer and support future research in the area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91858 0
Dr Lara Edbrooke
Address 91858 0
Department of Cancer Experiences Research,
Peter MacCallum Cancer Centre,
Level 9, 305 Grattan Street
Parkville, Melbourne
VIC 3000
Country 91858 0
Australia
Phone 91858 0
+61 3 85595234
Fax 91858 0
Email 91858 0
lara.edbrooke@petermac.org
Contact person for public queries
Name 91859 0
Dr Lara Edbrooke
Address 91859 0
Department of Cancer Experiences Research,
Peter MacCallum Cancer Centre,
Level 9, 305 Grattan Street
Parkville, Melbourne
VIC 3000
Country 91859 0
Australia
Phone 91859 0
+61 3 85595234
Fax 91859 0
Email 91859 0
lara.edbrooke@petermac.org
Contact person for scientific queries
Name 91860 0
Dr Lara Edbrooke
Address 91860 0
Department of Cancer Experiences Research,
Peter MacCallum Cancer Centre,
Level 9, 305 Grattan Street
Parkville, Melbourne
VIC 3000
Country 91860 0
Australia
Phone 91860 0
+61 3 85595234
Fax 91860 0
Email 91860 0
lara.edbrooke@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims of the proposal.
How or where can data be obtained?
Proposals should be directed to lara.edbrooke@petermac.org
To gain access data requestors will need to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 8137 0
Study protocol
Citation [1] 8137 0
Link [1] 8137 0
Email [1] 8137 0
lara.edbrooke@petermac.org
Other [1] 8137 0
Attachment [1] 8137 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary