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Trial registered on ANZCTR


Registration number
ACTRN12618000596202
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
17/04/2018
Date last updated
28/09/2022
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evidence-based intervention (“Fit for Treatment”) to prevent cancer treatment-induced toxicities in cancer patients: An effectiveness-implementation hybrid study
Scientific title
An evidence-based intervention (“Fit for Treatment”) to prevent cancer treatment-induced toxicities in cancer patients: An effectiveness-implementation hybrid study
Secondary ID [1] 294536 0
Nil known
Universal Trial Number (UTN)
U1111-1212-1253
Trial acronym
FFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any histologically-confirmed diagnosis of cancer 307316 0
Fatigue 307329 0
Cognitive Function 307330 0
Chemotherapy-induced Peripheral Neuropathy 325092 0
Cardiovascular Disease Risk 325093 0
Condition category
Condition code
Cancer 306424 306424 0 0
Any cancer
Neurological 306438 306438 0 0
Other neurological disorders
Cardiovascular 306439 306439 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves two components. The first, an interventional study which will compare the effects of a 12-week exercise intervention to usual care in individuals with cancer undertaking treatment. The second, a situational appraisal of this exercise intervention.

1. Exercise Intervention
The intervention will be a structured and individualised 12-week exercise program with the following components:
1) Participants will aim to complete 36 exercise sessions during this 12-week period (averaging 3 exercise sessions per week). If participants are unable to reach the target 36 sessions during these 12 weeks (i.e. they miss sessions due to excess treatment-related side effects), then they will be provided with the option of performing make-up sessions during this 12-week period (i.e. a participant may complete 2 sessions one week, then 4 sessions the following week). Alternatively, participants will be provided with the option of completing as many of the remaining sessions as possible during one additional week, making the intervention 13 weeks in duration (at most) for these participants.
2) For twelve (or thirteen) weeks, an accredited exercise physiologist (AEP) will directly supervise three hour-long gym-based sessions per week at the School of Human Movement and Nutrition Sciences gymnasium, UQ Healthy Living Clinic, Princess Alexandra Hospital, or an accredited exercise physiology clinic.
3) After six weeks, participants will then be given the option to be provided prescription for one of these three sessions as a self-managed home session, from weeks 7-12(13).
4) The AEP will individually tailor exercises for patients whose arm movement is restricted as a result of prior surgery and individualised to enhance neuromuscular strength, endurance, balance, cardiorespiratory fitness and flexibility. The AEP will be cognisant of neutropenic risks (e.g. no swimming will be prescribed for those on chemotherapy).
5) High-intensity aerobic exercise will be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and closely monitored by the AEP.
6) If participants decide to, and are deemed capable of, completing the second exercise session unsupervised at home from weeks 7-12(13) of the intervention, exercise maintenance strategies will be utilised to enhance adherence to the home-based exercise program.

2. Situational Appraisal
Princess Alexandra Hospital and Wesley Hospital clinicians (oncology nurses, physiotherapists, medical oncologists and service managers) and intervention participants will be invited to attend focus groups. Participants will be required to attend one of two focus groups, lasting no longer than 90 minutes in duration. Participants will be asked questions regarding resource utilisation, the knowledge and skills needed to implement the intervention, as well as cultural and structure barriers and facilitators.
Intervention code [1] 300834 0
Prevention
Intervention code [2] 300835 0
Treatment: Other
Intervention code [3] 300848 0
Lifestyle
Comparator / control treatment
Men and women with cancer undertaking any active cancer treatment randomised to the control group will continue with usual care, supplemented with advice about self-managed exercise and the lay version of the American Cancer Society exercise guidelines. Participants will be provided with a paper copy of these guidelines. Control group participants will be informed that they are not prohibited from exercising during the study period.
Control group
Active

Outcomes
Primary outcome [1] 305439 0
Change in self-reported fatigue scores, as assessed via the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (Version 4) questionnaire
Timepoint [1] 305439 0
Baseline, 6 weeks, 12 weeks (Primary timepoint) and 36 weeks after randomisation
Primary outcome [2] 321686 0
Change in cognitive function scores, as assessed via the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) (Version 3) questionnaire
Timepoint [2] 321686 0
Baseline, 6 weeks, 12 weeks (Primary timepoint) and 36 weeks after randomisation
Secondary outcome [1] 345247 0
Changes in physical, social/family, emotional and functional well-being scores, as assessed via the Functional Assessment of Cancer Therapy - General (FACT-G) (Version 4) questionnaire
Timepoint [1] 345247 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [2] 345248 0
Changes in autonomic and sensorimotor peripheral neuropathy symptoms scores, as assessed via the Chemotherapy-induced Peripheral Neuropathy Assessment Tool (CIPNAT) questionnaire
Timepoint [2] 345248 0
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, and 12 weeks and 36 weeks after randomisation
Secondary outcome [3] 345249 0
Change in quality of life scores, as assessed via the Assessment of Quality of Life – 8D (AQoL-8D) questionnaire
Timepoint [3] 345249 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [4] 345250 0
Changes in sensory function, as assessed via Mechanical Detection Thresholds using standardised von Frey monofilaments (1.65-6.65mN or 0.008-300g, respectively) bilaterally over the palmar surface of the middle finger and plantar surface of the middle toe
Timepoint [4] 345250 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [5] 345251 0
Changes in sensory function, as assessed via Vibration Disappearance Thresholds using a Rydel Seiffertuning Fork (64Hz, 8/8 scale) bilaterally over the palmar surface of the middle finger and plantar surface of the middle toe
Timepoint [5] 345251 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [6] 345252 0
Changes in location/s of sensory disturbance/s, as assessed via a body chart specially designed for this study
Timepoint [6] 345252 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [7] 345253 0
Changes in macro vascular function, as assessed via Brachial Artery Flow-mediated Dilation (BA-FMD) using doppler ultrasound
Timepoint [7] 345253 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [8] 345254 0
Changes in microvascular function, as assessed via Skin Blood Flow (SBF) using a PERIMED PeriFlux System 5000
Timepoint [8] 345254 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [9] 345255 0
Changes in macro vascular structure, as assessed via Carotid Intima-media Thickness (CIMT) using doppler ultrasound
Timepoint [9] 345255 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [10] 345256 0
Changes in macro vascular function, as assessed via Carotid Distensibility (CD) using both doppler ultrasound and a SphygmoCor XCEL PWA and PWV system
Timepoint [10] 345256 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [11] 345257 0
Changes in central blood pressures and pulse wave characteristics, as assessed via Pulse Wave Analysis (PWA) using a SphygmoCor XCEL PWA and PWV system
Timepoint [11] 345257 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [12] 345258 0
Changes in central pulse transfer times, as assessed via Pulse Wave Velocity (PWV) using a SphygmoCor XCEL PWA and PWV system
Timepoint [12] 345258 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [13] 345259 0
Changes in Autonomic Nervous System function, as assessed via Heart Rate Variability (HRV) using a resting 3-lead electrocardiogram
Timepoint [13] 345259 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [14] 345261 0
Changes in Autonomic Nervous System function, as assessed via heart rate and blood pressure responses to both deep breathing and a Valsalva Manoeuvre using a Finapres NOVA System
Timepoint [14] 345261 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [15] 345262 0
Changes in cytokine blood markers as assessed via;
- Interleukin 1 beta (IL-1beta)
- Interleukin 6 (IL-6)
- Interleukin 2 (IL-2)
- Tumor Necrosis Factor alpha (TNFalpha)
All bloods for Secondary Outcomes numbered 15-18 collected via 10mL and 5mL Ethylenediaminetetraacetic acid (EDTA) tubes, 10mL and 6mL serum tubes, and a 2mL glucose tube (33mL in total)
Timepoint [15] 345262 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [16] 345265 0
Changes in breast cancer cell growth, as assessed via cell culture analyses (using cell number assays and cell death assays)
All bloods for Secondary Outcomes numbered 15-18 collected via 10mL and 5mL Ethylenediaminetetraacetic acid (EDTA) tubes, 10mL and 6mL serum tubes, and a 2mL glucose tube (33mL in total)
Timepoint [16] 345265 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [17] 345266 0
Changes in metabolic and hormonal blood markers as assessed via;
- Low-density lipoprotein (LDL)
- High-density lipoprotein (HDL)
- Total cholesterol (TC)
- Triglycerides (TG)
- Fasting glucose
- Haemoglobin A1c (HbA1c)
- Insulin
- Insulin-like growth factor 1 (IGF-1)
- Arginine
- Citrulline
- Asymmetric dimethylarginine (ADMA)
- N-monomethylarginine (MMA)
- Global metabolite, proteome and subproteome analysis
All bloods for Secondary Outcomes numbered 15-18 collected via 10mL and 5mL Ethylenediaminetetraacetic acid (EDTA) tubes, 10mL and 6mL serum tubes, and a 2mL glucose tube (33mL in total)
Timepoint [17] 345266 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [18] 345267 0
Changes in inflammatory blood markers as assessed via;
- Cardiac Troponin-I
- Brain Natriuretic Peptide (BNP)
- High sensitivity C-reactive protein (CRP)
All bloods for Secondary Outcomes numbered 15-18 collected via 10mL and 5mL Ethylenediaminetetraacetic acid (EDTA) tubes, 10mL and 6mL serum tubes, and a 2mL glucose tube (33mL in total)
Timepoint [18] 345267 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [19] 345268 0
Changes in estimated overall muscle strength, as assessed via hand grip strength of both the dominant and non-dominant hands using a hand-held dynamometer
Timepoint [19] 345268 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [20] 345274 0
Changes in cardiorespiratory fitness (VO2Peak), as assessed via a Cardiopulmonary Exercise Test (CPET) using a cycle ergometer and metabolic system
Timepoint [20] 345274 0
Baseline, 12 weeks and 36 weeks after randomisation
Secondary outcome [21] 345604 0
Changes in habitual physical activity and sedentary behaviours, as assessed via accelerometery using a ActiGraph GT3X+ accelerometer
Timepoint [21] 345604 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [22] 345606 0
Adverse Events (AE) occurrence during the intervention period, as assessed via weekly face-to-face contact (at exercise sessions) from baseline to week 12. AE which might be directly related to the intervention (to be determined by an Accredited Exercise Physiologist) will be assessed using the US Department of Health and Human Services Common Terminology Criteria for Adverse Events (CTCAE). Possible AE include: - Cardiac events (e.g. Myocardial Infarction, Stroke, Cardiac Arrhythmia) - Musculoskeletal events (e.g. Development of Lower Back Pain, Knee Pain) - Chemotherapy-related events (e.g. Fatigue development, Immunocompromised i.e. flu) - Concurrent breast cancer treatment-related events (e.g. Oedema development, Skin irritation
Timepoint [22] 345606 0
Every supervised exercise session from baseline to week 12(13), throughout the 12-week exercise intervention period (Intervention group ONLY)
Secondary outcome [23] 345608 0
Resource utilisation in both groups during the intervention period, as assessed via discussion in the situational appraisal component of the study. Discussion of labour (e.g. to deliver the intervention) and non-labour (e.g. gymnasium use, pain medication) costs. Resource use will be costed at market rates (e.g. industrial award rates for labour costs), for use in cost-effectiveness analyses.
Timepoint [23] 345608 0
Following exercise intervention completion
Secondary outcome [24] 351095 0
Evaluation of factors relating to participant adherence to the exercise intervention, as assessed via a Cancer Exercise Adherence Survey specially designed for this study
Timepoint [24] 351095 0
Baseline (Intervention group ONLY)
Secondary outcome [25] 351096 0
Changes in habitual physical activity, as assessed via the Godin Leisure-Time Exercise Questionnaire (Godin) questionnaire
Timepoint [25] 351096 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation
Secondary outcome [26] 405694 0
Changes in body composition, as assessed via:
- Weight (measured by calibrated electronic scales)
- Height (measured by stadiometer)
- Body mass index (BMI) (calculated by researcher from collected height and weight data)
- Waist and hip circumferences (measured by experienced researcher with anthropometric tape)
- Waist-to-hip ratio (WHR) (calculated by researcher from collected circumferences data)
Timepoint [26] 405694 0
Baseline, 6 weeks, 12 weeks and 36 weeks after randomisation

Eligibility
Key inclusion criteria
- >18 years of age
- Cancer patients prescribed any anti-cancer treatment
- >1 month post-surgery
- No co-morbid condition or falls risk that could prevent safe completion of the intervention
- Cognitively capable of consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cancer patients prescribed any anti-cancer treatment
- Not planning to undergo surgery during the intervention period
- Any intellectual or physical disability which would make exercise intervention participation unsafe for the individual

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed at baseline. The randomisation process for this trial is performed by a person external to the study (an academic from The University of Queensland, St Lucia). A Chief Investigator for the trial then contacts the external person, who informs them of the participant’s randomisation at the conclusion of baseline testing sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals who consent to participate in the trial are randomised at a 1:1 ratio to either the intervention or control group by the external person. Randomisation is performed electronically online using permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analyses of raw data will be conducted on IBM SPPS Statistics for iOS. Categorical outcomes will be described using frequencies and proportions, and analysed using general estimating equations with a logistic regression model to account for repeated measures. ORs and 95% CIs will be reported. Control and intervention groups will be compared for continuous outcomes using mean/SD or median/interquartile range if not normally distributed. To account for the repeated measures, continuous outcome measures will be modelled using linear mixed-models. Assumptions of models will be examined by plotting the residuals using histograms and skewness and kurtosis measures. If the data do not meet assumptions, the 95% CIs will be bootstrapped to provide reliable estimates. Models will only be adjusted for characteristics that were unbalanced between groups and related to the outcome variable.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
26/09/2018
Actual
13/11/2018
Date of last participant enrolment
Anticipated
2/07/2021
Actual
14/06/2021
Date of last data collection
Anticipated
2/04/2022
Actual
21/04/2022
Sample size
Target
102
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10610 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 21602 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 22327 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 36525 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 299163 0
Government body
Name [1] 299163 0
Queensland Government Department of Health, Nursing and Midwifery Research Fellowship
Country [1] 299163 0
Australia
Funding source category [2] 299177 0
University
Name [2] 299177 0
School of Human Movement and Nutrition Sciences - University of Queensland
Country [2] 299177 0
Australia
Primary sponsor type
Individual
Name
Tina Skinner
Address
Senior Lecturer in Exercise Physiology

School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus, Queensland, 4072
Country
Australia
Secondary sponsor category [1] 298419 0
Individual
Name [1] 298419 0
Alexandra McCarthy
Address [1] 298419 0
Professor of Clinical Nursing, University of Queensland and Mater Health Services, School of Nursing, Midwifery and Social Work, University of Queensland, St Lucia, Queensland, Australia, 4067
Country [1] 298419 0
Australia
Secondary sponsor category [2] 298433 0
Individual
Name [2] 298433 0
Leanne Stone
Address [2] 298433 0
Director of Nursing

Division of Cancer Services, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland, 4102
Country [2] 298433 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300087 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 300087 0
Ethics committee country [1] 300087 0
Australia
Date submitted for ethics approval [1] 300087 0
17/01/2018
Approval date [1] 300087 0
05/04/2018
Ethics approval number [1] 300087 0
HREC/18/QPAH/38
Ethics committee name [2] 310258 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [2] 310258 0
Ethics committee country [2] 310258 0
Australia
Date submitted for ethics approval [2] 310258 0
14/12/2018
Approval date [2] 310258 0
05/03/2019
Ethics approval number [2] 310258 0
1901

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

Contacts
Principal investigator
Name 82526 0
Prof Alexandra McCarthy
Address 82526 0
Professor of Clinical Nursing, University of Queensland and Mater Health Services, School of Nursing, Midwifery and Social Work, University of Queensland, St Lucia, Queensland, 4067
Country 82526 0
Australia
Phone 82526 0
+61 4 2856 6283
Fax 82526 0
Email 82526 0
s.mccarthy@uq.edu.au
Contact person for public queries
Name 82527 0
Natalie Vear
Address 82527 0
Postdoctoral Research Fellow, School of Nursing, Midwifery and Social Work, University of Queensland, St Lucia, Queensland, 4067
Country 82527 0
Australia
Phone 82527 0
+61 4 7355 0978
Fax 82527 0
Email 82527 0
n.vear@uq.edu.au
Contact person for scientific queries
Name 82528 0
Alexandra McCarthy
Address 82528 0
Professor of Clinical Nursing, University of Queensland and Mater Health Services, School of Nursing, Midwifery and Social Work, University of Queensland, St Lucia, Queensland, 4067
Country 82528 0
Australia
Phone 82528 0
+61 4 2856 6283
Fax 82528 0
Email 82528 0
s.mccarthy@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We anticipate that the individual participants' data will not be made available on a publicly available repository. Should a journal request that the data be made available, we will apply for an amendment to make individual participant data available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1459Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-26-02-2019-14-50-29)-Study-related document.pdf
1460Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-26-02-2019-14-50-53)-Study-related document.pdf
1461Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-26-02-2019-14-51-23)-Study-related document.pdf
1462Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-26-02-2019-14-52-07)-Study-related document.pdf
14856Ethical approval  ethics@uchealth.com.au Ethical approval letter from UnitingCare Human Res... [More Details] 374867-(Uploaded-17-11-2021-17-06-55)-Study-related document.pdf
14857Ethical approval  ethics@uchealth.com.au Ethical approval letter from UnitingCare Human Res... [More Details] 374867-(Uploaded-17-11-2021-17-33-48)-Study-related document.pdf
14858Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-22-11-2021-10-10-43)-Study-related document.pdf
14859Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-22-11-2021-10-11-10)-Study-related document.pdf
14860Ethical approval  MSH-Ethics@health.qld.gov.au Ethical approval letter from Metro South Human Res... [More Details] 374867-(Uploaded-22-11-2021-10-12-40)-Study-related document.pdf



Results publications and other study-related documents

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