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Trial registered on ANZCTR


Registration number
ACTRN12619000952145
Ethics application status
Approved
Date submitted
17/06/2019
Date registered
8/07/2019
Date last updated
3/12/2020
Date data sharing statement initially provided
8/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
I-Move: A randomised controlled pilot trial of a personalised, semi-supervised exercise intervention to reduce fatigue for patients receiving immunotherapy for stage IV Melanoma
Scientific title
I-Move: A randomised controlled pilot trial of a personalised, semi-supervised exercise intervention to reduce fatigue for patients receiving immunotherapy for stage IV Melanoma
Secondary ID [1] 298512 0
Nil known
Universal Trial Number (UTN)
U1111-1235-4991
Trial acronym
iMove
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Melanoma 313310 0
Immunotherapy 313311 0
Fatigue 313312 0
Condition category
Condition code
Cancer 311753 311753 0 0
Malignant melanoma
Physical Medicine / Rehabilitation 311843 311843 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to receive the intervention will be prescribed a personalised, 12-week exercise program. The program will be run on an individual rather than group basis so each participant can commence the exercise program at the start of their immunotherapy regime

The intervention will be delivered by an accredited allied health Exercise Physiologist (EP) based at Peter Mac. EP’s at Peter Mac are specifically trained in the prescription of personalised exercise interventions for people with cancer, and in managing safety of patients undertaking exercise while receiving cancer treatment.

Each individual program will be designed by the EP, and will take into consideration:
• relevant demographic and clinical characteristics (e.g. disease, age etc.)
• physical suitability
• any safety considerations
• current exercise activities including work, home and leisure activities

As per the COSA guidelines for exercise in cancer care, the exercise prescription will allow patients to work towards and then maintain participation in:
•at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise each week; and
•two to three resistance exercise sessions each week involving moderate-to vigorous-intensity exercises targeting the major muscle groups

The EP will use the smartphone application: Physitrack to provide each participant with their exercise activity program. Patients can view the app at home to watch videos on how to do specific exercises, and to log activities completed. The app is designed so that the EP can create and amend the exercise program remotely. The participant can only view and log activity compliance, but not change the prescribed exercise program. Physitrack is free for patients to download.

EP guidance that will be provided as part of the exercise intervention will comprise:
•4 x face-to-face 1hr sessions at Peter Mac every three weeks, to coincide with immunotherapy infusion appointments,
•4 x 15min telephone supervision sessions scheduled for the week after the face-to-face session
•1x final 1hr face-to-face session at the conclusion of the exercise intervention to discuss ongoing physical activity and community resources patients can access close to home.

During both telephone and face-to-face sessions, the EP will monitor exercise progress, update exercise activities if required (for example increase or reduce intensity depending on the patient’s current capacity) and monitor safety (discussed further in section 4.0). There will be an option for the EP to add additional telephone sessions on the week between telephone and face-to-face contact if the participant requires additional monitoring or assistance.
Intervention code [1] 314827 0
Lifestyle
Intervention code [2] 314828 0
Behaviour
Comparator / control treatment
Participants randomised to receive the active control will be provided with a copy of the Cancer Council Victoria booklet “Exercise for people living with cancer”. This booklet provides generic information on exercise for people with cancer
Control group
Active

Outcomes
Primary outcome [1] 320436 0
This feasibility study's primary objective is to estimate the recruitment rate and appraise reasons for ineligibility.

This, along with other quantitative feasibility outcomes will be measured against pre-specified feasibility criteria. For the primary outcome variable this is that: on average, we will recruit 10 participants per month for three months. Reasons for ineligbility will be documented as part of screening for reporting against this outcome.
Timepoint [1] 320436 0
12 weeks post trial commencement
Secondary outcome [1] 371590 0
To investigate adherence to iMove consultations with the exercise physiologist (EP) (face to face and via telephone) .

This will be measured against pre-specified feasibility criteria comprising:

At least 75% of participants randomised to iMove will attend at least 3 of the first 4 face-to-face consultations
and
At least 75% of participants randomised to iMove will attend at least 3 of the first 4 telephone consultations
Timepoint [1] 371590 0
24 weeks post trial commencement
Secondary outcome [2] 371591 0
To investigate the acceptability of the Exercise Physiology consultation sessions.

This will be assessed using a qualitative interviews. Intervention participants will be interviewed at 12 weeks (post intervention conclusion) and Exercise Physiologists will be interviewed at the conclusion of the trial.
Timepoint [2] 371591 0
12 weeks (intervention participants)
24 weeks post trial commencement
Secondary outcome [3] 371592 0
To investigate adherence to a personalised, prescribed exercise intervention.

Exercise physiologists will record adherence at each face-to-face and telephone consultation on a three-point likert scale according to % of activities completed (good = >80%; moderate =50-80%; poor <50%). This is recorded from both the participants point of view and the EP's perspective. The Godin Leisure-time Activity Level Questionnaire will also be used to monitor physical activity throughout the duration of the trial.
Timepoint [3] 371592 0
Recorded throughout intervention delivery (12wks)
Secondary outcome [4] 371593 0
To investigate the acceptability of a personalised, prescribed exercise intervention.

This will be assessed using a qualitative interviews. Intervention participants will be interviewed at 12 weeks (post intervention conclusion) and Exercise Physiologists will be interviewed at the conclusion of the trial.
Timepoint [4] 371593 0
12 weeks (intervention participants)
24 weeks trial commencement
Secondary outcome [5] 371594 0
To determine the number and type of exercise-related adverse events.

Exercise physiologists will record each exercise-related adverse event per patient self-report (type, duration, severity) as they occur.

Common exercise-related adverse events comprise sore muscles or feelings of fatigue.
Timepoint [5] 371594 0
24 weeks post trial commencement
Secondary outcome [6] 371595 0
To assess the acceptability and appropriateness of study measures.

This will be assessed through investigation of completeness of Patient Reported Outcome Measures and through the patient qualitative interview.

Patient reported outcome measures comprise:
Functional Assessment of Chronic Illness Therapy (FACIT-F)
Brief Fatigue Inventory (BFI)
PROMIS Ability to Participate in Social Roles and Activities—Short Form 6a
Short Form 36 health survey questionnaire (SF-36)
Edmonton Symptom Assessment Scale (ESAS)
The Godin Leisure-time Physical Activity Questionnaire (GLTEQ)
Timepoint [6] 371595 0
24 weeks post trial commencement
Secondary outcome [7] 371596 0
To assess the retention of participants at 16 and 24 weeks.

This will be assessed through data recording patients who withdraw or are lost to follow-up.
Timepoint [7] 371596 0
at the conclusion of the trial all data regarding withdrawal or lost to follow-up will be analysed
Secondary outcome [8] 371598 0
To assess the practicability and utility of additional blood collection.

Barriers or issues with blood collection will be recorded.
Timepoint [8] 371598 0
24 weeks post trial commencement
Secondary outcome [9] 371990 0
To investigate the potential impact of iMove on fatigue and other patient-reported outcomes, as well as objective measures of fitness.

As this is a feasibility trial, it is not adequately powered to investigate between group differences. Preliminary comparisons to assess potential impact will be conducted on:
Fatigue (BFI; FACIT-F)
Quality of Life (SF-36)
Role functioning (PROMIS Ability to participate in Social Roles and Activities Short Form 6a)
Symptoms (Edmonton Symptom Assessment Scale)
Physical Activity (Godin Leisure-time Physical Acitivity Questionnaire)

Objective measures of fitness which will be reviewed include:
Six-minute walk test
Arm curl test
Chair stand test
The Australia-modified Karnofsky Performance Scale (AKPS)
Timepoint [9] 371990 0
Measured at baseline (week 1); week 7, week 13, week 16 and week 24

Eligibility
Key inclusion criteria
• Aged 18 years or older
• Diagnosis of stage IV Melanoma
• Scheduled to commence receiving single agent Ipilimumab, Nivolumab or Pembrolizumab; or combination Ipilimumab and Nivolumab immunotherapy, and have not yet had their second infusion
• Able to speak and read English
• Deemed suitable to take part in an exercise intervention by their treating clinician
• Access to a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Screening:
• ECOG performance >2
Physical/Safety Assessment:
• Peripheral Neuropathy: An assigned WHO Grade of 3 or above will preclude participation in the trial.
• Contra-indications to exercise testing including the following
o Myocardial infarction or unstable angina in last 3 months
o Cerebrovascular event or transient ischemic attack in last 3 months
o Pulmonary embolic event within 3 months, existing acute or chronic deep vein thrombosis
o Presentation with active sepsis

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 will be concealed from participants until after they have completed baseline physical and safety assessment and baseline patient reported outcome questionnaires (PROMs). The research team will perform randomisation and notification of randomisation outcome to both patients and the EP. For those randomised to the intervention group, the EP will commence development of their exercise program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly allocated to the intervention or control 1:1 using a computer-generated allocation sequence using a block size of 6. Randomisation will be stratified by current exercise activity: whether COSA guidelines are met or not. This information is determined as part of the physical assessment by the EP.

Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
SAMPLE SIZE:

The target sample is 30 participants. All 30 participants must have been judged physically suitable by the EP following physical and safety assessment. As such, more than 30 participants may provide informed consent.
The target sample is largely pragmatic, based on available funds and trial time frames; however, stepped rules of thumb for pilot sample sizes were also considered. If 30 patients are accrued in 3 months, then the expected monthly accrual rate is 10 patients per month with an exact 95% confidence interval of 4.8 to 18.4 patients per month, corresponding to a 95% CI for the accrual rate over 3 months of 20.2 to 42.8 patients. If the target of 30 patients is reached in less than 3 months, the trial will terminate early. Power will be insufficient to detect minimum clinically important differences between trial arms on PROMs; however, if the 95% confidence intervals for trial arm comparisons at follow-ups T3 through T5 contain important differences, the intervention will be viewed as promising.

ANALYSIS PLAN FOR QUANTITATIVE DATA

Feasibility and acceptability outcomes

The main feasibility outcomes are recruitment and retention. The main acceptability outcome is adherence to the iMove consultation sessions. Recruitment data will be summarised using a rate and 95% confidence interval using the Poisson distribution. Adherence and retention data will be summarised using a proportion and 95% confidence interval; the latter will be estimated using the Wilson method. The main feasibility and acceptability outcomes will be judged against pre-specified criteria (Table 3). Counts and percentages will be used to summarise time data collected in the EP-Log on EP time. Both total time (e.g. total time per patient) and activity-specific time (e.g. intervention preparation) will be summarised and described.

Exercise-related adverse events.

Counts and percentages will be used to summarise data on exercise-related adverse events. These will be tabulated by severity grade.

Patient-reported outcomes and objective measures of fitness.

Patient-reported outcome data includes responses to the FACIT-F, Brief Fatigue Inventory, PROMIS Ability to participate in social roles and activities 6a, Edmonton Symptom Assessment Scale, SF-36 and Godin-Shephard Leisure-Time Physical Activity Questionnaire. Objective measures of fitness include results of the 30-second Chair Stand Test, the Six-Minute Walk Test, the Arm Curl Test and the Australian-modified Karnofsky Performance Scale. Counts and percentages will be used to summarise data on missing items and forms or tests for patient-reported outcome measures and objective measures of fitness, respectively. Patient-reported outcome measures will be scored according to author guidelines, including the GSLTPAQ Leisure Score Index. Means, standard deviations and ranges will be used to summarise scores for patient-reported outcome measures and objective measures of fitness at each time-point by trial arm.
Analysis of patient-reported outcome data and objective measures of fitness will be carried out by fitting a linear mixed model to each outcome separately. Models will include fixed effects for trial arm, time and a trial arm-by-time interaction, as well as a random participant effect. Baseline assessment will be included as a covariate. Differences between trial arms at post-baseline assessments will be calculated from these models

Data from the blood sub-study.

Counts and percentages will be used to summarise the completeness of serum marker data from routine blood collection, as well as the completeness of more sophisticated pro-inflammatory and anti-inflammatory marker data from additional blood collection. If appropriate, linear mixed models will be used to calculate the mean change from baseline in each trial arm and the between-groups differences at T2 through T5.

ANALYSIS PLAN FOR QUALITATIVE DATA

Data generated through the EP-LOG open text boxes (described in table 2) will be analysed using content analysis methodology. Content analysis will be employed to analyse the data, as it allows for exploration of phenomenon such as motivation, experiences and views of participants in order to answer clinical relevant health questions 50. Data will be classified into codes, categories and (where relevant) themes using an iterative process; initially deductively by text box category within the EP-LOG, and then inductively by frequency of novel information. At the conclusion of analysis findings will be presented and discussed with key members of the project team. Discrepancies will be discussed and resolved until consensus with the coding framework was reached.

Data generated through the qualitative interviews will be audio-recorded, transcribed and analysed using interpretive description methodology 51. Interpretive description was selected for analysis as it provides practical outcomes for clinical health services improvement 51. As a methodology it is more appropriate for analysing this type of data, where descriptions of adherence or fatigue; or barriers and facilitators to exercise are provided by the EP and participants (as compared with content analysis) as it allows for deeper and richer thematic exploration of the data rather than sorting and summing common statements.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Majority of participants were too unwell to complete final surveys
Date of first participant enrolment
Anticipated
Actual
17/05/2019
Date of last participant enrolment
Anticipated
30/09/2019
Actual
23/09/2019
Date of last data collection
Anticipated
30/03/2020
Actual
17/01/2020
Sample size
Target
30
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14008 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 26787 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 303058 0
Charities/Societies/Foundations
Name [1] 303058 0
Peter MacCallum Cancer Centre Foundation
Country [1] 303058 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street Parkville Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 303040 0
None
Name [1] 303040 0
Address [1] 303040 0
Country [1] 303040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303608 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 303608 0
Ethics committee country [1] 303608 0
Australia
Date submitted for ethics approval [1] 303608 0
11/02/2019
Approval date [1] 303608 0
01/05/2019
Ethics approval number [1] 303608 0
HREC/48927/PMCC-2019

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

Contacts
Principal investigator
Name 94242 0
Dr Donna Milne
Address 94242 0
Peter MacCallum Cancer Centre
305 Grattan Street Parkville Victoria 3000
Country 94242 0
Australia
Phone 94242 0
+61 3 85597838
Fax 94242 0
Email 94242 0
[email protected]
Contact person for public queries
Name 94243 0
Donna Milne
Address 94243 0
Peter MacCallum Cancer Centre
305 Grattan Street Parkville Victoria 3000
Country 94243 0
Australia
Phone 94243 0
+61 3 85597838
Fax 94243 0
Email 94243 0
[email protected]
Contact person for scientific queries
Name 94244 0
Donna Milne
Address 94244 0
Peter MacCallum Cancer Centre
305 Grattan Street Parkville Victoria 3000
Country 94244 0
Australia
Phone 94244 0
+61 3 85597838
Fax 94244 0
Email 94244 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; informed consent for data sharing was not sought from participants. This is only a small pilot feasibility trial, participant numbers expected to be <30


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2365Ethical approval    377796-(Uploaded-17-06-2019-14-05-30)-Study-related document.pdf
2366Informed consent form    377796-(Uploaded-17-06-2019-14-04-42)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.