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Trial registered on ANZCTR


Registration number
ACTRN12622001333707
Ethics application status
Approved
Date submitted
23/09/2022
Date registered
17/10/2022
Date last updated
17/10/2022
Date data sharing statement initially provided
17/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-faceted assessment model for monitoring performance and perceptual pre-exercise readiness in individuals undergoing cancer treatment
Scientific title
A multi-faceted assessment model for monitoring performance and perceptual pre-exercise readiness in individuals undergoing cancer treatment
Secondary ID [1] 308027 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 327707 0
Condition category
Condition code
Cancer 324786 324786 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants must undertake the assessment battery on several occasions (including familiarisation) over a single cycle of chemotherapy (fortnightly or three-weekly administration). The assessment battery will be aligned with their standard care twice-weekly exercise training session attendance at the Olivia Newton-John Cancer Wellness and Research Centre. The duration of each assessment will be approximately 30 minutes. Before commencing the assessment battery, participants will be required to attend a familiarisation session (review all assessments before undertaking assessment session visits), followed by four to six study visits over a single cycle of chemotherapy (depending on the chemotherapy schedule). These assessments include a countermovement jump, a 10-metre usual fast walk speed test, grip strength and a series of standardised questionnaires that will assess your illness perceptions, psychological distress, quality of life, mood, dietary intake, and current physical activity status. All assessments will be conducted before each scheduled exercise training session attendance and supervised by an accredited exercise physiologist with specialist expertise in cancer.
Intervention code [1] 324481 0
Early Detection / Screening
Comparator / control treatment
Uncontrolled, single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332610 0
The countermovement jump and lower limb kinetics will be assessed bilaterally to determine neuromuscular performance using a portable dual force plate device sampling at 1000 Hz (ForceDecks, FDLite, Vald Performance Pty Ltd, Brisbane, Australia)[18]. Following the three attempts, jumping and landing data will be calculated instantaneously and extracted from the ForceDecks software (Version 2.0). Other outcome variables, such as peak take-off force, landing force, and take-off impulse, will be assessed as a composite primary outcome. The initial take-off includes the eccentric countermovement and concentric propulsion phase, and landing will be defined from the initial group contact and return to the standing position. The take-off impulse will be calculated as the area under the force-time curve above the standing bodyweight force. To account for the influence of body weight on countermovement jump kinetics, results will be normalised to body weight force and reported in Newtons.
Timepoint [1] 332610 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)



Primary outcome [2] 332612 0
Symptom severity will be assessed by the Edmonton Symptom Assessment Scale
Timepoint [2] 332612 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [1] 414045 0
A 10-metre usual and fast walk speed test will assess gait speed (metres per second) via electronic timing gates (SmartSpeed, Fusion Sport, Brisbane, Australia). Participants will perform two attempts of the usual and fast-walking pace (as a composite). All assessments will be completed in duplicate, with time and velocity recorded to the nearest 0.1 second or 0.1 metres/per second.
Timepoint [1] 414045 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [2] 414046 0
Grip strength will be measured using a hand dynamometer (Saehan Medical, South Korea). The average of three attempts bilaterally (independent of hand dominance) will be documented.
Timepoint [2] 414046 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [3] 414049 0
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer QLQ-30
Timepoint [3] 414049 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [4] 414050 0
Illness perceptions will be assessed by the illness perception questionnaire (IPQ-R)
Timepoint [4] 414050 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [5] 414051 0
Diet and hydration status will be assessed using a 24-hour dietary recall
Timepoint [5] 414051 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [6] 414052 0
The six dimensions of the mood anger, confusion, depression, fatigue, tension, and vigour will be assessed using the Profile of Mood States (POMs)
Timepoint [6] 414052 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [7] 414053 0
Physical activity will be assessed using a modified Godin Leisure-Time Exercise Questionnaire
Timepoint [7] 414053 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
Secondary outcome [8] 414054 0
Psychological distress will be assessed using the brief symptom inventory (BSI-18)
Timepoint [8] 414054 0
(1) Baseline - scheduled to receive or within one month of chemotherapy,
(2) Visit 1 and 2 (within one week since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 3 and 4 (two weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)
(3) Visit 5 and 6 (three weeks since the first administration of chemotherapy (primary endpoint) (this is dependent on the chemotherapy regimen)

Eligibility
Key inclusion criteria
• 18 years and older
• Histologically confirmed cancer diagnosis
• Scheduled to receive or within one month of chemotherapy (cyclic)
• Not currently meeting the physical activity guidelines for individuals with cancer.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not currently receiving cancer treatment (e.g., post-cancer treatment),
• Previously received cancer treatment (chemotherapy) within the past five years
• Diagnosed with a musculoskeletal, neurological, cardiovascular, or pulmonary
condition that would deem them unsafe to participate by their treating clinician
• Diagnosed with widespread bone metastatic disease
• Recently diagnosed with osteoporosis
• Currently exceeds the physical activity guidelines for individuals with cancer
• Cannot read or write English

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analyses will be performed using SPSS v.27 (IBM Australia, Ltd, NSW, Australia). Continuous data will be presented as mean SD unless stated otherwise. Categorical variables will be presented as frequency or percentage. Test-retest reliability will be determined by descriptive statistics for all measures across each visit and screened for normal distribution using the Shapiro-Wilk test in SPSS [v27]. The intraclass correlation coefficient, typical error and coefficient of variation will be calculated using a customised spreadsheet. The minimum detectable change will be a minimum detectable change at a 95% confidence interval (MDC95) as a typical error × 1.96.
Further analyses will include paired sample t-tests, repeated analysis of variance (ANOVA) and effect size statistics to examine the main effects of a treatment cycle and time-course changes. Effect size values of 0.2, 0.5 and >0.8 are considered small, moderate, and large, respectively. Bivariate correlations between pre-exercise readiness and other clinically relevant variables will be performed by Pearson correlation. Statistically significant variables (P<0.05) will be retained and entered into a hypothesis-driven multi-variable regression analysis. All tests will be 2-tailed with statistical significance set at an alpha level of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
Date of last participant enrolment
Anticipated
10/10/2024
Actual
Date of last data collection
Anticipated
7/11/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23205 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 38571 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 312290 0
Hospital
Name [1] 312290 0
Olivia Newton-John Cancer Wellness and Research Centre
Country [1] 312290 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 313835 0
None
Name [1] 313835 0
None
Address [1] 313835 0
Country [1] 313835 0
Other collaborator category [1] 282433 0
University
Name [1] 282433 0
Australian Catholic University
Address [1] 282433 0
School of Behavioural and Health Sciences
Australian Catholic University
Level 1, The Daniel Mannix Building,
17 Young Street, Fitzroy, VIC 3065
Locked Bag 4115 Fitzroy MDC VIC 3165
Country [1] 282433 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311659 0
Austin Health
Ethics committee address [1] 311659 0
145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 311659 0
Australia
Date submitted for ethics approval [1] 311659 0
23/05/2022
Approval date [1] 311659 0
20/09/2022
Ethics approval number [1] 311659 0
HREC/85957/Austin-2022

Summary
Brief summary
Monitoring acute changes in symptoms (perceptual wellness) during chemotherapy is essential for determining when to implement or optimise exercise training for cancer patients. This study aims to assess whether a selection of outcome measures is able to provide reliable information regarding cancer patients' perceptual wellness whilst they are actively receiving chemotherapy.

Who is it for?
You may be eligible for this study if you are aged between 18-85, have a confirmed cancer diagnosis, are scheduled to begin chemotherapy immediately or within one month, and are not currently meeting the optimal physical activity guidelines for cancer. patients.

Study details
All participants who choose to enrol in this study will be asked to attend up to 7 sessions at the Olivia Newton-John Cancer Wellness and Research Centre in Melbourne (VIC). Each session is anticipated to take 30 minutes. Participants will be asked to complete a series of physical tasks and complete a set of questionnaires regarding their current symptoms and physical and mental well-being. All sessions will be supervised by an accredited exercise physiologist with specialist expertise in cancer and will be scheduled at 2-3 weekly interval (single cycle of chemotherapy only) to align with your standard care exercise regime.

It is hoped this research will determine whether the selected outcome measures are able to provide reliable information regarding cancer patients' perceptual wellness whilst they are actively receiving chemotherapy. Suppose the results of this study are positive. In that case, they may be used to guide exercise training schedules for future cancer patients, to ensure that they are receiving the best care without over-exerting themselves.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121890 0
Ms Ashley Bigaran
Address 121890 0
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 121890 0
Australia
Phone 121890 0
+61 3 9496 9446
Fax 121890 0
Email 121890 0
ashley.bigaran@austin.org.au
Contact person for public queries
Name 121891 0
Ms Ashley Bigaran
Address 121891 0
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 121891 0
Australia
Phone 121891 0
+61 3 9496 9446
Fax 121891 0
Email 121891 0
ashley.bigaran@austin.org.au
Contact person for scientific queries
Name 121892 0
Dr Christian Pitcher
Address 121892 0
Australian Catholic University
115 Victoria Parade, Fitzroy VIC 3065
Country 121892 0
Australia
Phone 121892 0
+61 3 9953 3185
Fax 121892 0
Email 121892 0
christian.pitcher@acu.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17178Ethical approval    384708-(Uploaded-23-09-2022-12-58-06)-Study-related document.pdf



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.