Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000797572p
Ethics application status
Submitted, not yet approved
Date submitted
30/05/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
RECENTRE: Determining the Acceptability and Efficacy of The Enhancing Women's Recovery after Cancer Treatment Program
Scientific title
RECENTRE: Determining the Acceptability, Safety and Efficacy of The Enhancing Women's Recovery after Cancer Treatment Program.
Secondary ID [1] 312227 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
RECENTRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 333926 0
Gynaecological cancer 333927 0
Condition category
Condition code
Cancer 330594 330594 0 0
Breast
Cancer 330595 330595 0 0
Cervical (cervix)
Cancer 330596 330596 0 0
Ovarian and primary peritoneal
Cancer 330597 330597 0 0
Womb (Uterine or endometrial cancer)
Cancer 330598 330598 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure


RECENTRE is a single-cohort implementation study; hence, all participants receive the intervention. The 12-week digital intervention targets health education and health promotion incorporating international recommendations for the core outcomes of physical activity, diet, and minimising alcohol and body weight management as well as evidence-based strategies to manage smoking cessation, sleep, stress, menopausal symptoms, and sexual health over a 12-week period.

Physical activity recommendations align with Australia’s physical activity and exercise guidelines for all Australians whilst accounting for sedentary behaviour guidelines and World Cancer Research Fund cancer prevention guidelines. For example to be moderately physically active, equivalent to brisk walking, for greater than or equal to 30 minutes daily. As fitness improves, aim for greater than or equal to 60 minutes of moderate (or for greater than or equal to 30 minutes of vigorous) physical activity every day and to be as lean as possible within the healthy weight range.

Dietary recommendations include: eat mostly foods of plant origin; limit consumption of energy dense foods; avoid sugary drinks; limit intake of red meat and avoid processed meat; and avoid alcohol consumption. These are based on several guidelines including those from the Australian Dietary Guidelines, World Cancer Research Fund and the American Institute for Cancer Research.

All other recommendations have been clinically informed by experts in the field of cancer recovery. Participants are provided the content firstly on a day-to-day basis (weeks 1-3) and then weekly (weeks 4-12) to build on, expand, revisit and reflect on knowledge gained.

The timing and application of these strategies reflect the life stage of these women and are personalized to meet their individual goals and functional capacities. A baseline needs assessment assists participants to identify areas of priority and focus whilst working through the intervention content (accessing or omitting content relevant to personal preference and at a frequency of their choosing). Time taken to complete each section will vary from person to person depending on the content they choose, but we anticipate on average participants will spend an average of one-2 hours per week over the course of the 12 weeks to complete the full content available including completion of their RECENTRE Wellbeing Journal and RECENTRE thermometer. Reflections and a mid-program needs assessment helps to realign goals and priorities with the aim to build self-efficacy for personalised long-term health management. Additional customisation is offered to participants assessed as requiring additional support (i.e. advancer cancer, distressed) and by way of personalised virtual nurse specialist consultations.

The content (covering but not limited to topics noted above) will be delivered individually via a self-directed interactive online platform. Participants flagged as requiring additional in-person support will be identified the needs assessments as well as via completion of three-weekly RECENTRE thermometers embedded in the intervention Wellbeing Journal. The RECENTRE thermometer is a single visual analogue scale (scores range 0 – 10) that essentially ‘flags’ if the participant is experiencing distress and or need, and therefore requires additional support from a clinical team member. Any participant identified as having advanced cancer at baseline will be offered additional clinical support for the duration of the intervention (maximum three consultations) and referral to appropriate clinical Associate Investigators based at Mater, if required.

Each participant requiring additional in-person support will be offered individual virtual clinical consultations with trained clinicians via Zoom, Teams, FaceTime, or telephone to tailor their lifestyle program, and motivate them towards goal achievement, self-management, and a sustainably healthy lifestyle.

The RECENTRE program provides all necessary health promotion content and supports participants to log relevant health and lifestyle information into the Wellbeing Journal, which is populated with responses to activities over time. The participant start date triggers a progression bar which is also displayed within the Wellbeing Journal. A weekly physical activity planner encourages participants to plan for their physical activity in the following week. The intervention platform incorporates news and announcements; new evidence; an overview of the program; and an online moderated ‘community’, programmed and monitored by RECENTRE clinical and technical teams, that allows participants to communicate with each other and ask basic questions relating to RECENTRE. Security of information entered by participants is ensured through encrypted data transmission and secure storage. The website and digital intervention is adapted for all computing platforms, including mobile phones however for ease of use the module content and updating of the Wellbeing Journal is best completed using a larger screen.

Consultations (if required) with a nurse specialist trained in the intervention and with expertise in supportive cancer care will be conducted via video- or teleconferencing and will last approximately one hour. Therefore participants can undertake this study from their own homes or anywhere comfortable to them where they can access a Wi-Fi connection and privacy. In keeping with privacy guidelines, no recording of the consultations is undertaken.
Intervention code [1] 328678 0
Lifestyle
Intervention code [2] 328679 0
Behaviour
Comparator / control treatment
No Control Group - all participants receive the intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338348 0
A. To determine the Feasibility of the intervention via delivery of RECENTRE to 800 women treated for either breast or gynaecological cancers at Mater facilities.
Timepoint [1] 338348 0
a) Feasibility: Measure at Time 0 (Baseline), on completion of study recruitment
b) Feasibility: Measured at Time 1 ( 12 weeks - completion of intervention)
c) Feasibility: Measured at Time 1 ( 12 weeks - completion of intervention)
d) Feasibility: Measured at Time 1 (12 weeks -
completion of intervention).
Primary outcome [2] 338472 0
To determine the Acceptability of the intervention via delivery of RECENTRE to 800 women treated for either breast or gynaecological cancers at Mater facilities.
Timepoint [2] 338472 0
Acceptability: Measured at T1 (12 weeks - completion of intervention)
Primary outcome [3] 338473 0
Safety: Type, number and severity of adverse events (according to Common Terminology Criteria for Adverse Events guidelines) requiring disruption or modification of the intervention.
Data will be collected by clinical nurse specialist and/or self-reported via intervention monitoring tools.

Timepoint [3] 338473 0
Safety: Measured throughout the study
Secondary outcome [1] 435602 0
Composite outcome - To determine the Reach of the RECENTRE study.
Timepoint [1] 435602 0
Assessed 12 months post-commencement of study, using data collected at baseline',
Secondary outcome [2] 435603 0
Quality of Life
Timepoint [2] 435603 0
Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
Secondary outcome [3] 436077 0
Physical Activity
Timepoint [3] 436077 0
Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
Secondary outcome [4] 436535 0
Dietary adequacy
Timepoint [4] 436535 0
Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
Secondary outcome [5] 436536 0
Emotion and Unmet Needs
Timepoint [5] 436536 0
Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
Secondary outcome [6] 436537 0
Composite Outcome - Health Costs
Timepoint [6] 436537 0
a) Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
b) Measured at: Time 0 (Baseline) and 12 Months post baseline.
Secondary outcome [7] 436538 0
Composite outcome - Adoption of the RECENTRE Study.
Timepoint [7] 436538 0
a) Measured at: Time 0 (Baseline), Time 1 (12 weeks - completion of intervention), Time 2 (24 weeks).
b) Measured at: Time 0 (Baseline).
Secondary outcome [8] 436539 0
Participants’ use of and perception of the intervention materials
Timepoint [8] 436539 0
a) Measured at Time 1 (12 weeks - completion of intervention).
b) Measured at Time 1 (12 weeks - completion of intervention).
c) Measured throughout the study period.
Secondary outcome [9] 436540 0
Interventionists’ fidelity to the intervention protocol.
Timepoint [9] 436540 0
Measured at Time 1 (12 weeks - completion of intervention).

Eligibility
Key inclusion criteria
• Confirmed diagnosis of breast or gynaecological cancer (all stages).
• Have completed intensive cancer treatment more than 4 weeks ago including surgery, chemotherapy, immunotherapy and/or radiotherapy (maintenance therapy as specified by treating team permitted e.g. oral chemotherapy; targeted therapies for example trastuzumab; endocrine therapy; bisphosphonates) and up to 36 months post-intensive treatment.
• >18 years of age.
• Received care through any Mater facility.
• Are residing in Queensland, Australia.
• Cognitively capable of consent.
• Have access to the internet with a stable connection.
• Own, or have access to, a computer, tablet device or smartphone.
• Willing and able to comply with all study requirements, including intervention, timing, and nature of required assessments.
• Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to.
• Voluntary written (electronic) informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those who do not fit the above inclusion criteria.
• Women who are palliative, or on intensive treatment and/or unlikely to be able to complete the program, or unable to provide informed consent.
• Any clinical contraindication that precludes safe completion of the program in the judgement of the project team

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
1. The sample size for the consumer intervention (n = 800) for this study is deemed suitable by the investigator team to address the research aim and objectives.
In our work with women with Stage I-III breast cancer (N=351, APP1056856) we reported dropout rates of 12.5% (Week 12) and 14.6% (Week 24)33. The most common reason for dropout cited by participants was survey burden, which we have minimised here. Considering these dropout rates, and the inclusion in this study of women with Stage IV cancers (who might have serious comorbidities), we conservatively estimate a 25% dropout at Week 12. With a sample size of 800 participants, and assuming 600 (75%) complete the intervention at Week 12, we can estimate rates for Aim 1 (feasibility, acceptability, safety) outcomes with a 95% confidence interval ranging between ±2% and ±4%. For the Aim 2 dual primary clinical effectiveness outcomes (derived from the Short Form-36 [SF36] quality of life measure) N=600 participants with complete Week 0-12 data provide 91.6% power to detect a mean of 2 normed units in the mental component summary (MCS), and 99% power to detect a mean change of 2 normed units of physical component summary (PCS) of the SF36. This assumes a change in SD of 11.7 for MCS and 9.5 for PCS (based on previous work using the same instrument) 12 using a one-sided paired t-test at the 1% significance level. We need, therefore, at least 800 participants with baseline quality of life data.
2. Quantitative analysis:
Categorical outcomes will be described using frequencies and proportions. Continuous data will be assessed for normality using standardised tests. Normally distributed data will be presented as mean and 95% confidence intervals or standard deviation, and non-normally distributed data as median and interquartile range. All analyses will be carried out in Statistical Analysis System. Analysis of feasibility, acceptability, and safety target rates will be summarised as frequency (%) and 95% confidence intervals. Each target outcome will be classified as met if the rate exceeds the cut-off

3. . Qualitative analysis:
Qualitative data collected will be content analysed to assess the study objectives

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
3/01/2028
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26599 0
Mater Private Hospital Brisbane - South Brisbane
Recruitment hospital [2] 26601 0
Mater Misericordiae Hospital Bundaberg - Bundaberg
Recruitment hospital [3] 26602 0
Mater Misericordiae Hospital Rockhampton - Rockhampton
Recruitment hospital [4] 26604 0
Mater Private Hospital Redland - Cleveland
Recruitment hospital [5] 26605 0
Mater Private Hospital Springfield - Springfield Central
Recruitment hospital [6] 26606 0
Mater Misericordiae Hospital Mackay - North Mackay
Recruitment hospital [7] 26614 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 42642 0
4101 - South Brisbane
Recruitment postcode(s) [2] 42643 0
4670 - Bundaberg
Recruitment postcode(s) [3] 42644 0
4700 - Rockhampton
Recruitment postcode(s) [4] 42646 0
4163 - Cleveland
Recruitment postcode(s) [5] 42647 0
4300 - Springfield Central
Recruitment postcode(s) [6] 42648 0
4740 - North Mackay

Funding & Sponsors
Funding source category [1] 316606 0
Government body
Name [1] 316606 0
National Health and Medical Research Council
Country [1] 316606 0
Australia
Funding source category [2] 316614 0
Charities/Societies/Foundations
Name [2] 316614 0
Mater Foundation
Country [2] 316614 0
Australia
Funding source category [3] 316638 0
Hospital
Name [3] 316638 0
Mater Hospital
Country [3] 316638 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 318788 0
None
Name [1] 318788 0
Address [1] 318788 0
Country [1] 318788 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315390 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 315390 0
Ethics committee country [1] 315390 0
Australia
Date submitted for ethics approval [1] 315390 0
03/06/2024
Approval date [1] 315390 0
Ethics approval number [1] 315390 0
Ethics committee name [2] 315399 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 315399 0
Ethics committee country [2] 315399 0
Australia
Date submitted for ethics approval [2] 315399 0
01/07/2024
Approval date [2] 315399 0
Ethics approval number [2] 315399 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134554 0
Prof Alexandra (Sandie) McCarthy
Address 134554 0
Griffith University, Rm 8.69 Building G40, 1 Parklands Drive Southport. QLD 4215
Country 134554 0
Australia
Phone 134554 0
+61 7 5678 7629
Fax 134554 0
Email 134554 0
[email protected]
Contact person for public queries
Name 134555 0
Dr Sarah Balaam
Address 134555 0
Griffith University, Rm 8.69 Building G40, 1 Parklands Drive Southport. QLD 4215
Country 134555 0
Australia
Phone 134555 0
+61 7 5678 7629
Fax 134555 0
Email 134555 0
[email protected]
Contact person for scientific queries
Name 134556 0
Dr Sarah Balaam
Address 134556 0
Griffith University, Rm 8.69 Building G40, 1 Parklands Drive Southport. QLD 4215
Country 134556 0
Australia
Phone 134556 0
+61 7 5678 7629
Fax 134556 0
Email 134556 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
IPD will not be available for this implementation study


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.