Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001352897
Ethics application status
Approved
Date submitted
17/08/2021
Date registered
7/10/2021
Date last updated
20/09/2022
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility of introducing personalised exercise prescription from point-of-diagnosis in individuals receiving treatment for early-stage breast or colon cancer in Christchurch, New Zealand.
Scientific title
Investigating the feasibility of introducing personalised exercise prescription from point-of-diagnosis in individuals receiving treatment for early-stage breast or colon cancer in Christchurch, New Zealand.
Secondary ID [1] 305061 0
Nil known
Universal Trial Number (UTN)
U1111-1258-6385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 323267 0
Colon cancer 323268 0
Condition category
Condition code
Cancer 320838 320838 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 320839 320839 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This single centre, multidisciplinary study aims to explore the feasibility of introducing supervised, personalised exercise prescription, any time from point-of-diagnosis for 12-weeks in individuals receiving treatment for early-stage breast or colon cancer in Christchurch, New Zealand. Exercises will be individualised and prescribed by an accredited Exercise Physiologist with more than 5-years-experience. Sessions will be a combined approach of aerobic and resistance training, delivered in a hospital-based gym 1-3 x / week for up to 60 mins per session. Adherence will be assessed to investigate feasibility of the programme. There will be two options for people to self-select to participate in the research study, either in the exercise group or the non-exercise group.
Once details of participation have been communicated and consent recorded, all participants will undergo a baseline assessment. From the baseline assessment, individuals in the exercise group will have an individualised exercise programme prescribed one-on-one. The aim will be to reach a combined moderate-to-high intensity resistance and cardiovascular-based programme during each session if this is possible based on how each participant presents. Cardiovascular exercises may include running, walking or biking and resistance exercises may include squats, lunges, balance and modified upper limb exercises. Participants in the non-exercise group will be advised to continue with their usual daily routines. All participants will be asked to keep a journal of their activity and to bring this journal to each assessment.

Participants may be referred at any time within the preoperative phase, and therefore the number of sessions completed prior to surgery will vary. Following surgery the exercise will not recommence until approval is received from the treating surgeon. Exercise reassessments and interventions will commence gradually and progressively to allow the participant to recover. The aim will be to reach a combined moderate-to-high intensity resistance and cardiovascular-based programme during each session. Following surgery, exercise prescription will be modified and scaled based on the participant’s mobility, pain and energy levels. The goal of this programme is to individualise the programme to the participant so adaptions to frequency, intensity, time and type will be frequent to ensure the participant is supported and the exercise programme is responsive to the needs of the participant. Reassessments will occur every 4-weeks to assess the progress of the participant’s exercise capacity throughout their treatment. The exercise programme will continue supervised for 12 weeks. Following this, participants will either be transitioned into an independent programme, to a community-based class or continue with the exercise intervention if it is required.
The intensity of sessions will be based on the participant’s heart rate at lactate threshold. In addition, an adapted ‘Readiness to be Active’ scale will be used prior to each exercise session. This ‘Readiness to be Active’ scale will take account of the participant’s sleep, mood, energy levels and motivation for the day. Sessions will be adapted based on this ‘Readiness to be Active’ scale on a daily basis. Rate of perceived exertion using the Borg scale will be used throughout each session to verify how the participant is experiencing each session.
The resistance training will involve six to eight exercises targeting the major muscle groups and functional movement capacities. The intensity of each session will be assessed through the participant’s previous exercise history and assessment outcomes. If participants have not been doing any resistance training over the past 12-weeks then the training load will commence slowly and progressively, commencing with lower loads and higher repetitions around 50-80% of the participants estimated one-repetition maximum (1RM), around 8-12RM. Exercises will be adapted to assist participants with musculoskeletal discomforts and range of motion restrictions.
Flexibility and mobility is important to achieve for activities of daily living and functional movements. Each participant’s range of motion will be assessed during the initial assessment. Exercises will be prescribed to assist with their movement and improve their musculoskeletal discomfort. Shoulder range of motion may be affected following breast cancer surgery and exercises will be gradual and progressive to allow for this return to function.
Intervention code [1] 321456 0
Lifestyle
Comparator / control treatment
There will be two options for people to self-select to participate in the research study, either in the exercise group or the non-exercise group. The non-exercise group will complete the baseline and exercise intervention assessments, but not the supervised exercise sessions, and they will be asked to continue with their normal daily physical activity and routines.
Control group
Active

Outcomes
Primary outcome [1] 328634 0
Determine feasibility of introducing a supervised, personalised exercise programme from point of diagnosis through surgery and chemotherapy in individuals with early-stage breast or colon cancer in the New Zealand clinical setting. This will be evaluated by the composite primary endpoint of participant attendance (ratio of total attended to planned treatments >70%) and loss to follow-up (non-completion of exercise intervention assessments (< 20% LTF). Attendance checklists will be used to monitor attendance and any lost to follow up participants.
Timepoint [1] 328634 0
On completion of the exercise programme.
Secondary outcome [1] 399767 0
Determine individual rate of return to pre-surgical functional capacity for each participant. This will be assessed using a standard 6 min walking test (6MWT) performed pre-surgery and at each subsequent assessment.
Timepoint [1] 399767 0
Baseline assessment and following reasessments every 4 weeks during the intervention exercise programme up to week-12 of intervention.
Secondary outcome [2] 399769 0
Determine the feasibility of obtaining other functional measures of exercise capacity for each participant by assessing participants' lactate threshold using a treadmill test. Measured by successful test completion by participants at baseline assessment and 12-week final assessment.
Timepoint [2] 399769 0
Lactate threshold testing to only occur at baseline and final assessment. Baseline assessment on initial assessment into the programme and final assessment.
Secondary outcome [3] 399770 0
Explore the feasibility of a supervised, personalised exercise programme by recording the exercise intensity for each participant using heart rate throughout supervised exercise sessions.
Timepoint [3] 399770 0
Heart rate will be monitored during each supervised exercise session. Baseline assessment and following reasessments every 4 weeks during the intervention exercise programme up to week-12 of the intervention
Secondary outcome [4] 399771 0
Determine the feasibility of collecting clinicopathological data on outcomes using surgical complication rates (Clavien-Dindo classification).
Timepoint [4] 399771 0
Clinicopathological data will be assessed on completion of the exercise intervention at week 12.
Secondary outcome [5] 399772 0
Determine the feasibility of collecting Person Reported Outcomes (PROs) including quality of life using the McGill's quality of life questionnaire and a qualitative analysis of expanded responses.
Timepoint [5] 399772 0
Baseline assessment and following reasessments every 4 weeks during the intervention exercise programme up to week-12 of the exercise intervention
Secondary outcome [6] 399773 0
Examine the feasibility of collecting the amount of physical activity self-recorded by participants in daily physical activity journals. Assessed through completion status of the journals at the end of the intervention for each participant, reviewed at each assessment.
Timepoint [6] 399773 0
Assessed during reviews every four weeks during the 12-weeks of the exercise programme.
Secondary outcome [7] 399774 0
Determine the feasibility of measuring the concentrations of inflammatory cytokines in blood samples collected from participants at time-points throughout exercise therapy (e.g. inflammatory cytokines associated with surgery, chemotherapy and exercise). Assessed through completion status of collecting samples from participants.
Timepoint [7] 399774 0
Blood samples are to be collected at routine blood collection, where another assay will be collected for this study. Time points for collection will then align with routine blood collection and analysed every four weeks during the exercise intervention up to week-12.
Secondary outcome [8] 399775 0
Determine the feasibility of analysing complete blood counts assayed for each participant as per routine clinical practice throughout treatment. Assessed through completion status of collecting samples from participants.
Timepoint [8] 399775 0
Blood samples are to be collected at routine blood collection, where another assay will be collected for this study. Time points for collection will then align with routine blood collection and analysed every four weeks during the exercise intervention up to week-12.
Secondary outcome [9] 401505 0
Determine the feasibility of obtaining other functional measures of exercise capacity for each participant by assessing participants' grip strength using a Jamar Smart Hand Dynamometer . Measured by successful test completion by participants.
Timepoint [9] 401505 0
Baseline assessment and following reasessments every 4 weeks during the intervention exercise programme up to week-12.
Secondary outcome [10] 401506 0
Determine the feasibility of obtaining other functional measures of exercise capacity for each participant by assessing participants' 30-second sit-to-stand . Measured by successful test completion by participants.
Timepoint [10] 401506 0
Baseline assessment and following reasessments every 4 weeks during the intervention exercise programme up to week-12.
Secondary outcome [11] 401509 0
Determine the feasibility of collecting adherence and completion rates of chemotherapy for each participant. Assessed through completion of data collection.
Timepoint [11] 401509 0
On completion of chemotherapy collected through participants' records.
Secondary outcome [12] 401510 0
Determine the feasibility of collecting dose modification of chemotherapy for each participant. Assessed through completion of data colleciton.
Timepoint [12] 401510 0
On completion of chemotherapy collected through participants' records.
Secondary outcome [13] 401511 0
Determine the feasibility of collecting chemotherapy-related toxicities for each participant. Assessed through completion of data collection.
Timepoint [13] 401511 0
On completion of chemotherapy collected through participants' records.
Secondary outcome [14] 401512 0
Determine the feasibility of collecting tumour pathology data for each participant. Assessed through completion of data collection.
Timepoint [14] 401512 0
Clinicopathological data will be assessed on completion of the exercise intervention at week-12
Secondary outcome [15] 401513 0
Determine the feasibility of collecting Person Reported Outcomes (PROs) including cancer-related fatigue on a VAS 1-10 and a qualitative analysis of expanded responses.
Timepoint [15] 401513 0
Baseline assessment and following reassessments every 4-weeks through to week-12
Secondary outcome [16] 401514 0
Determine the feasibility of collecting Person Reported Outcomes (PROs) including psychological distress on a VAS 1-10 and a qualitative analysis of expanded responses.
Timepoint [16] 401514 0
Baseline assessment and following reassessments every 4-weeks through to week-12

Eligibility
Key inclusion criteria
Men and women able to give informed written consent.
18 years or older with adequate hematologic, renal and liver function.
Treatment for primary cancer; chemotherapy treatment, radiation therapy, or surgery commenced within the last twelve months
Good performance status (i.e. Eastern Cooperative Oncology Group (EGOC) performance status of 0–1).
Early stage breast or colon cancer (stage I-III, no distant metastasis).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute infectious diseases.
Severe cardiovascular (e.g. unstable ischemic heart disease, uncontrolled arrhythmia) or respiratory (e.g. shortness of breath at rest) disease.
Severe anaemia (Hb<100).
Unable to read and speak English

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)
Allocation is not concealed
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data generated by the study will include: patient demographics, participant recruitment, attendance and retention, functional measurements of exercise capacity for each participant over treatment (baseline, post-surgery/pre-chemotherapy, chemotherapy), clinicopathological data on treatment outcomes (surgical, oncology/chemotherapy, tumour pathology), person reported outcomes and participant recorded daily activity data. The proposed research is a feasibility study, so power and sample size calculations are not required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/10/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/02/2023
Actual
Sample size
Target
90
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 24045 0
New Zealand
State/province [1] 24045 0
Canterbury

Funding & Sponsors
Funding source category [1] 309456 0
Charities/Societies/Foundations
Name [1] 309456 0
Cancer Society Canterbury West Coast division
Country [1] 309456 0
New Zealand
Funding source category [2] 309458 0
University
Name [2] 309458 0
University of Canterbury
Country [2] 309458 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 310425 0
University
Name [1] 310425 0
University of Otago Christchurch
Address [1] 310425 0
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
Country [1] 310425 0
New Zealand
Other collaborator category [1] 281947 0
Hospital
Name [1] 281947 0
Canterbury District Health Board - Christchurch Hospital
Address [1] 281947 0
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
Country [1] 281947 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309249 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 309249 0
Ethics committee country [1] 309249 0
New Zealand
Date submitted for ethics approval [1] 309249 0
12/03/2021
Approval date [1] 309249 0
09/08/2021
Ethics approval number [1] 309249 0
21/STH/69

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

Contacts
Principal investigator
Name 113490 0
Prof Nick Draper
Address 113490 0
University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 113490 0
New Zealand
Phone 113490 0
+64 3 3693878
Fax 113490 0
Email 113490 0
[email protected]
Contact person for public queries
Name 113491 0
Jessica Allan
Address 113491 0
University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 113491 0
New Zealand
Phone 113491 0
+64 274956686
Fax 113491 0
Email 113491 0
[email protected]
Contact person for scientific queries
Name 113492 0
Jessica Allan
Address 113492 0
University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 113492 0
New Zealand
Phone 113492 0
+64 27 495 6686
Fax 113492 0
Email 113492 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
No decision has been confirmed surrounding this.


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.