ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Any cancer

Intervention/exposure

Study type

Observational

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]

Early Detection / Screening

Comparator / control treatment

Uncontrolled, single-arm study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

(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]

Symptom severity will be assessed by the Edmonton Symptom Assessment Scale

Timepoint [2]

(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]

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]

(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]

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]

(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]

Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer QLQ-30

Timepoint [3]

(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]

Illness perceptions will be assessed by the illness perception questionnaire (IPQ-R)

Timepoint [4]

(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]

Diet and hydration status will be assessed using a 24-hour dietary recall

Timepoint [5]

(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]

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]

(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]

Physical activity will be assessed using a modified Godin Leisure-Time Exercise Questionnaire

Timepoint [7]

(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]

Psychological distress will be assessed using the brief symptom inventory (BSI-18)

Timepoint [8]

(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

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Olivia Newton-John Cancer Wellness and Research Centre

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Country [1]

Other collaborator category [1]

University

Name [1]

Australian Catholic University

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

145 Studley Rd, Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/05/2022

Approval date [1]

20/09/2022

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Ms Ashley Bigaran

Address

Olivia Newton-John Cancer Wellness and Research Centre, Austin Health
145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 9446

Email

[email protected]

Contact person for public queries

Name

Ashley Bigaran

Address

Olivia Newton-John Cancer Wellness and Research Centre, Austin Health
145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 9446

Email

[email protected]

Contact person for scientific queries

Name

Christian Pitcher

Address

Australian Catholic University
115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9953 3185

Email

[email protected]

Trial Review

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