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Trial registered on ANZCTR


Registration number
ACTRN12622000741785
Ethics application status
Approved
Date submitted
28/04/2022
Date registered
24/05/2022
Date last updated
24/05/2022
Date data sharing statement initially provided
24/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study evaluating a structured telehealth Lifestyle intervention (Exercise And Diet) for early-stage Breast Cancer Survivors (LEAD-4-BCS) undergoing neo-adjuvant/ adjuvant chemotherapy
Scientific title
A phase 2 feasibility study evaluating a structured telehealth Lifestyle intervention (Exercise And Diet) for early-stage Breast Cancer Survivors (LEAD-4-BCS) undergoing neo-adjuvant/ adjuvant chemotherapy
Secondary ID [1] 307019 0
None
Universal Trial Number (UTN)
Trial acronym
LEAD-4-BCS feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 326145 0
physical inactivity 326147 0
weight gain 326148 0
Condition category
Condition code
Cancer 323464 323464 0 0
Breast
Diet and Nutrition 323465 323465 0 0
Obesity
Physical Medicine / Rehabilitation 323466 323466 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm intervention where participants will undergo one exercise and one diet education session per week for the first 10 weeks, followed by one exercise session and one diet education session every fortnight for the next 4 weeks so that a total of 24 supervised group exercise and group diet education can be delivered delivered virtually over a 14-week period throughout chemotherapy. For participants who have 12 weeks chemotherapy remaining can choose to have weekly exercise and diet education sessions for 12 weeks continuously.

Both dietary and exercise sessions will be delivered via Zoom, a virtual platform and each session will run for an hour.

The exercise sessions will be run by an exercise physiologist (EP). Each group session will have no more than 15 participants per group. Individual exercise prescription will be provided at the baseline EP assessment session, and participants will be encouraged to follow the exercise prescriptions/instructions provided earlier during their intervention sessions. If unable to follow the exercise prescription, a new prescription will be given during the study intervention. The aim for these group exercise sessions is to encourage participants to exercise; reaching pre-specified level of intensity is not the main goal of exercise intervention. Participants will also be encouraged to do daily exercise in-between exercise sessions. EP will provide exercise/physical activities suggestions for in-between supervised group exercise sessions; based on individual's preference and capacity (e.g. daily walk or swimming twice per week, etc).

Dietary sessions will be facilitated by a dietitian. Each session will focus on providing information related to healthy eating, and encouraging healthy eating patterns using motivational interview skills. There will be a mixture of group activities and discussion during the dietary sessions. Information/handouts used in this study are publicly available resources or resources from established organizations (e.g. Cancer council, World Cancer Research Fund, Health Department, etc)

Strategies to monitor adherence will include daily diary (using survey function) asking participant's dietary intake and exercise/physical activities.
Intervention code [1] 323466 0
Lifestyle
Intervention code [2] 323540 0
Prevention
Intervention code [3] 323541 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331206 0
The primary outcome of the study is a composite primary outcome from participants’ adherence rate (self-reported) to exercise and diet prescriptions. Food and exercise diary (daily reporting but adherence score check at 4-week intervals) will be used to determine adherence rate.
For example, participant A has been given the exercise prescription of 90mins of exercise per week (60mins of group exercise session and a 30min walk) and dietary prescription of 2 pieces of fruit with 3 serves of vegetables per day for the first 4 weeks. Participant A's diary indicating participant's average weekly exercise and daily intake of fruit and vegetables will be used to calculate adherence rate.
Timepoint [1] 331206 0
Post study intervention assessment will be conducted on week 16 +/- 1 week (or within 3 weeks of last intervention session).
Secondary outcome [1] 409177 0
Acceptability of the intervention through participation rate - audit of study database for successful registration over number of patients screened.
Timepoint [1] 409177 0
After recruitment period is closed.
Secondary outcome [2] 409178 0
Safety (any adverse events experienced by a participant during group sessions e.g. sprain ankle, fall, etc) to ensure the program can be delivered safely over a virtual platform.

Participants are instructed to self-report adverse events, and events. Events are documented as injury requiring hospitalisation or incident not requiring hospital admission, along with a brief description of the injury.
Timepoint [2] 409178 0
Data will be collected at the end of each study intervention session during the study intervention period but to be reported as secondary outcome at the end of the study intervention.
Secondary outcome [3] 409179 0
Effect on chemotherapy tolerability as determined by whether participant completed the intended chemotherapy prescription. This will be reported by participant as either completed chemotherapy regimen as planned (YES/NO) and type and number of cycles completed.
Timepoint [3] 409179 0
To be reported once* either as part of post intervention assessment questionnaire (week 16 +/-1 week) or if participant is still undergoing chemotherapy at the time of post intervention assessment, this outcome will be assessed at 6-month assessment (week 26 +/-2 weeks after baseline assessment).
Secondary outcome [4] 409180 0
Effects on quality of life using quality of life measurement EORTC QLQ-C30 with breast cancer module (QLQ-BR23),
Timepoint [4] 409180 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month after baseline assessment (week 26 +/-2 weeks after baseline assessment).
Secondary outcome [5] 409181 0
Effect on lifestyle outcome using World Cancer Research Fund (WCRF) adherence score as surrogate marker for healthy lifestyle.
WCRF is a composite score based on body mass index, waist circumference, physical activity, fruit, vegetable and total fibre intake, consumption of red and processed meat, ultra-processed foods, sugar-sweetened drinks and alcohol intake.
Timepoint [5] 409181 0
To be calculated at post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [6] 409182 0
Effects on physical health using body mass index (BMI). BMI assessed as composite of weight measured using home scale and estimated height.
Timepoint [6] 409182 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [7] 409184 0
Cost of intervention based on resources used, including time for exercise physiologist and dietitian to run the program.
This outcome is assessed through audit of staff log book where time to run the intervention sessions and time required to prepare for the sessions will be recorded by the exercise physiologist and dietitian.
Timepoint [7] 409184 0
After study completion
Secondary outcome [8] 409479 0
Acceptability of the program assessed through attendance rate of ‘e-supervised’ sessions. Measuring attendance at all dietary and exercise sessions with a threshold of 70% attendance at all mandatory sessions will be considered acceptable.
Timepoint [8] 409479 0
Attendance rate assessed as the number of prescribed sessions completed as determined by audit of session attendance checklists at the end of study intervention
Secondary outcome [9] 409545 0
Acceptability of the intervention through semi-structured interview to explore participant satisfaction/acceptability. One-to-one interview will be conducted by independent researcher either through phone or zoom and will be audio recorded.
Timepoint [9] 409545 0
Interview will be conducted on exit of the study intervention (during study if earlier withdrawal or after completion of 12 sessions of study intervention)
Secondary outcome [10] 409546 0
Distress assessed using distress thermometer
Timepoint [10] 409546 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [11] 409547 0
Effects on motivational readiness using investigator developed questionnaires.
Timepoint [11] 409547 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [12] 409550 0
Effects on physical health using fitness assessment - timed up and go (TUG) - to assess falls risk. This is a composite secondary outcome.
Timepoint [12] 409550 0
To be reported as part of post intervention assessment (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [13] 409551 0
Effects on physical health using fitness assessment - 2min step test - to assess aerobic endurance
Timepoint [13] 409551 0
Post intervention assessment (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [14] 409552 0
Effects on physical health using fitness assessment - 30s chair stand - to test lower body strength and endurance. This is a composite secondary outcome.
Timepoint [14] 409552 0
Post intervention assessment (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [15] 409553 0
Effects on physical health using waist circumference
Timepoint [15] 409553 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [16] 409554 0
Effect on lifestyle outcome - step counts using pedometer or similar device
Timepoint [16] 409554 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [17] 409555 0
Effect on lifestyle outcome - diet changes using 3-day food diary
Timepoint [17] 409555 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [18] 409556 0
Effect on lifestyle outcome - smoking status using investigator developed questionnaire
Timepoint [18] 409556 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [19] 409557 0
Effect on lifestyle outcome - alcohol intake using investigator developed questionnaire
Timepoint [19] 409557 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [20] 409558 0
Effect on lifestyle outcome - physical activity through modified Godin Leisure-Time Exercise Questionnaire (LTEQ)
Timepoint [20] 409558 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)
Secondary outcome [21] 409910 0
Effects on self-efficacy using investigator developed questionnaires.
Timepoint [21] 409910 0
To be reported as part of post intervention assessment questionnaire (week 16 +/-1 week) and 6-month assessment (week 26 +/-2 weeks after baseline assessment)

Eligibility
Key inclusion criteria
- Adults aged 18 years and over with early-stage breast cancer diagnosis who are to be treated with chemotherapy for curative intent (neo-adjuvant or adjuvant);
- Have a minimum of 12 weeks of chemotherapy remaining to allow study participation;
- Not on a special diet for medical reasons that contradicts high fibre, low fat dietary recommendations;
- No known comorbidities limiting exercise (e.g. uncontrolled blood sugar level, blood pressure, etc). Medical clearance is needed if unable to pass exercise and fall risk screening questions;
- Have valid email address and able to use it to access materials/web links for questionnaire and zoom links. If participants have no active email address but willing to create one for the study they will be eligible;
- Have access to a device that enables access to a virtual platform (e.g, Zoom) to participate in exercise and dietary session;
- Willing and able to comply with all study requirements, timing and/or nature of required assessments;
- Fluent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Fall risk without medical clearance
- Cognitively impaired or unable to give informed consent;
- Visual impairment affecting ability to follow instructions on screen to exercise safely;
- Other advanced stage of malignancy;
- Concurrent illness requiring high dose steroids (e.g. 25mg Prednisolone (or equivalent);
- Presence of any psychological, familial, sociological or comorbidities potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence, drug abuse, eating disorder.

Study design
Purpose of the study
Prevention
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
Descriptive analyses will be performed to report baseline characteristics; non-parametric tests will be used if the continuous data are not normally distributed
Primary analysis will determine the average adherence to the study intervention (SD, effect size) and proportion of patients meeting 60% adherence rate of the exercise and diet recommendations at post-intervention analysis, and the 95% confidence interval (CI).

Secondary outcomes will be compared using chi-squares for categorical variables, paired t-test to measure changes in continuous data (e.g. weight change, distress, etc) at post intervention assessment and follow up period at week 26).
Regression models will be used to explore continuous endpoints. Sub-group analysis will be used to explore factors affecting adherence and attendance rate.
Qualitative data from exit interview (from semi-structured interviews) will be analysed using an interpretive description to guide analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
Date of last participant enrolment
Anticipated
30/07/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22274 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 22275 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [3] 22276 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [4] 22277 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 22278 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [6] 22279 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 22280 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [8] 22281 0
Mater Sydney - North Sydney
Recruitment hospital [9] 22282 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [10] 22283 0
Orange Health Service - Orange
Recruitment hospital [11] 22284 0
Bathurst Base Hospital - Bathurst
Recruitment postcode(s) [1] 37436 0
2139 - Concord
Recruitment postcode(s) [2] 37437 0
2830 - Dubbo
Recruitment postcode(s) [3] 37438 0
2086 - Frenchs Forest
Recruitment postcode(s) [4] 37439 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 37440 0
2109 - Macquarie Park
Recruitment postcode(s) [6] 37441 0
2747 - Kingswood
Recruitment postcode(s) [7] 37442 0
2560 - Campbelltown
Recruitment postcode(s) [8] 37443 0
2060 - North Sydney
Recruitment postcode(s) [9] 37444 0
2576 - Bowral
Recruitment postcode(s) [10] 37445 0
2800 - Orange
Recruitment postcode(s) [11] 37446 0
2795 - Bathurst

Funding & Sponsors
Funding source category [1] 311329 0
University
Name [1] 311329 0
Faculty of Medicine and Health, University of Sydney
Country [1] 311329 0
Australia
Primary sponsor type
University
Name
Faculty of Medicine and Health, University of Sydney
Address
Faculty of Medicine and Health
Level 2, The Quadrangle (A14)
Camperdown
NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 312704 0
None
Name [1] 312704 0
Address [1] 312704 0
Country [1] 312704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310829 0
Concord Repatriation General Hospital Human Research Ethics Committee
Ethics committee address [1] 310829 0
Ethics committee country [1] 310829 0
Australia
Date submitted for ethics approval [1] 310829 0
08/03/2022
Approval date [1] 310829 0
29/04/2022
Ethics approval number [1] 310829 0
REGIS ethics application number: 2022/ETH00290

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

Contacts
Principal investigator
Name 119010 0
Dr Cindy Tan
Address 119010 0
Building 38 Nutrition and Dietetics Department Concord Hospital
Hospital Road NSW Concord 2139
Country 119010 0
Australia
Phone 119010 0
+61 2 9767 6328
Fax 119010 0
Email 119010 0
[email protected]
Contact person for public queries
Name 119011 0
Cindy Tan
Address 119011 0
Building 38 Nutrition and Dietetics Department Concord Hospital
Hospital Road NSW Concord 2139
Country 119011 0
Australia
Phone 119011 0
+61 2 9767 6328
Fax 119011 0
Email 119011 0
[email protected]
Contact person for scientific queries
Name 119012 0
Cindy Tan
Address 119012 0
Building 38 Nutrition and Dietetics Department Concord Hospital
Hospital Road NSW Concord 2139
Country 119012 0
Australia
Phone 119012 0
+61 2 9767 6328
Fax 119012 0
Email 119012 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 sharing will need to go through internal and HREC review.


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.