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Trial registered on ANZCTR


Registration number
ACTRN12616000641493
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
17/05/2016
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
23/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting cancer survivors to stand up, sit less and move more
Scientific title
A pilot study of a text message intervention to improve whole-of-day activity in cancer survivors participating in clinical exercise rehabilitation
Secondary ID [1] 289138 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 298641 0
sedentary behaviour 298642 0
cancer survivorship 298735 0
Condition category
Condition code
Public Health 298704 298704 0 0
Health promotion/education
Cancer 298781 298781 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will attend a 4-week exercise clinic for cancer surivors. Participation in the exercise clinic is optional for people with a previous diagnosis of cancer. Participants will be prescribed 1 h, individualized, supervised exercise sessions once weekly for 4 weeks. Participants will be encouraged to increase their physical activity levels outside of the exercise sessions. All testing and training sessions will be conducted in the School of Human Movement and Nutrition Sciences Gymnasium. Participants are individually supervised (see below) in groups of up to 10 participants. Participants will complete sessions prescribed by final year clinical exercise physiology students in a 2:1 student:participant ratio supervised by Accredited Exercise Physiologists in a 1:2 AEP:participant ratio. The exercise program will be individualized to address participant goals, preferences, medical history and initial assessment results. Each 1 h session included: low intensity aerobic warm-up (5–10 min); four to six progressive upper and lower body resistance exercises of 10–12RM (targeting the chest, biceps, triceps, quadriceps, hamstrings and latissimus dorsi muscle groups) using machine, free weights and/or resistance bands; balance activities; low intensity aerobic cool down (5–10 min); static muscle stretching activities; and education on the benefits of exercise for health. Resistance load was increased by 5–10 percent when participants exceeded the prescribed RM. Accredited exercise physiologists will record attendance and any adverse (i.e. any untoward medical occurrence occurring during the exercise sessions), or serious adverse events (i.e. adverse events that are still ongoing at the end of the study period).

In addition to participating in the 4-week exercise clinic, half of the participants will be randomly allocated to receive a text messaging intervention that will commence at the same time as the clinic. The 3-month intervention consists of a suite of text messages tailored through coaching sessions that draw on participants' activity data. Participants receive a minimum of 4 text messages per fortnight that will target: reducing overall sedentary time, breaking up prolonged periods (30 mins+) of sedentary time with light intensity activities (including standing), and increasing MVPA. The text messaging intervention will begin with a face-to-face, one-on-one coaching session (approx. 30 minutes duration conducted at the university) to: 1) orientate the participant to the ‘whole-of-day’ approach; and, 2) collect information to tailor the text message content and timing. Participants’ baseline activity data will be used by the coach to guide participants to identify goals and strategies for changing their daily activities. Following the initial coaching session, each intervention participant will be sent a minimum of four tailored text messages per fortnight for the 12-week period, with more frequent texts able to be provided at the request of the participant. The text messages will target: 1) education (overall and prolonged sitting and MVPA); 2) real time prompting (prolonged sitting and MVPA); and, 3) goal checking (MVPA). Intervention participants will engage in another face-to-face coaching session after the 4-week Exercise Clinic (approx. 30 minutes duration) to update their preferences for text message content and timing. All coaching sessions will be conducted by a qualified health professional (e.g. Exercise Physiologist/Physiotherapist). Attendance at coaching sessions will be recorded. The participants are not required to wear any monitoring devices throughout the intervention other than that described in the outcome measures.
Intervention code [1] 294654 0
Behaviour
Intervention code [2] 294713 0
Lifestyle
Comparator / control treatment
The comparator group is the 'usual care' exercise clinic for cancer survivors. This is a 4 week 1:1 exercise clinic, with one exercise session per week. This clinic is run annually through the Human Movement and Nutrition Sciences School at The University of Queensland.
Control group
Active

Outcomes
Primary outcome [1] 298187 0
Overall sitting time per day (h/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion.
Timepoint [1] 298187 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [1] 323430 0
Prolonged sitting time (>30 mins) (h/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion.
Timepoint [1] 323430 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [2] 323432 0
Standing time (min/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion.
Timepoint [2] 323432 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [3] 323434 0
Stepping time (overall and at slow and fast cadence) (min/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion.
Timepoint [3] 323434 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [4] 323435 0
Use of time (min/day; Sleep, Screen, Quiet Time, Social, Self-Care, Work,
Transport, Chores, Physical Activity) measured using the Multimedia Activity Recall for Children and Adults, a computerised time use recall tool. This will be administered to participants via computer assisted telephone interview (CATI).
Timepoint [4] 323435 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [5] 323436 0
Muscular strength measured using 1RM method for leg press.
Timepoint [5] 323436 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [6] 323437 0
Feasibility - assessed using attendance at coaching sessions and text analytics (number of SMS sent/received)
Timepoint [6] 323437 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [7] 323438 0
Acceptability - assessed using a purpose-designed survey to examine participants' perception of intervention
Timepoint [7] 323438 0
12-weeks post commencement of intervention.
Secondary outcome [8] 323673 0
Exercise capacity measured using the 400m walk test
Timepoint [8] 323673 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [9] 323674 0
Physical function measured using a repeated chair stand and usual gait speed
Timepoint [9] 323674 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [10] 323675 0
Anthropometry measured using waist circumference, height and weight.
Timepoint [10] 323675 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [11] 323680 0
Quality of life measured using the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire
Timepoint [11] 323680 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [12] 323683 0
Grip strength will be measured using a spring-loaded grip dynamometer for the dominant hand.
Timepoint [12] 323683 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [13] 323686 0
Balance will be measured using a timed tandem stance
Timepoint [13] 323686 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [14] 323687 0
Resting heart rate will be measured after 5 min of seated rest using a Polar Heart Rate Monitor
Timepoint [14] 323687 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [15] 323688 0
Resting blood pressure will be measured using a sphygmomanometer after 5 min of seated rest
Timepoint [15] 323688 0
At baseline, 4- and 12-weeks post commencement of intervention.
Secondary outcome [16] 346816 0
Acceptability of the intervention assessed using a purpose designed survey
Timepoint [16] 346816 0
12-week follow up

Eligibility
Key inclusion criteria
Participants have to opt in to the exercise clinic in order to be eligible for this study. articipation in the exercise clinic is optional for people with a previous diagnosis of cancer. To be included in the study, participants will have a previous diagnosis of cancer (excluding childhood cancers) and be at least one-month post surgery, with relevant information obtained from their medical practitioner (e.g. comorbidities, injuries, medications) to assist with exercise testing and prescription. Participants must also own a mobile phone.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have established metastatic bone disease, or cardiopulmonary or metabolic disorders that will prevent safe participation in the testing or exercise sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At time of enrolling in the study allocation will be concealed. Allocation will be concealed by not performing the sequence generation until after all participants are enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Randomisation will be stratified by schedule of exercise session that they will be attending.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be conducted using SPSS (v22, IBM Corp, Armonk, NY). The initial analyses will describe characteristics of participants at baseline. For feasibility assessment, categorical variables will be reported as numbers and percentages and continuous variables as mean and standard deviation. Generalised linear models will be used to examine intervention effects on the primary and secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 13211 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 293519 0
University
Name [1] 293519 0
The University of Queensland
Address [1] 293519 0
Brisbane, Queensland. 4072
Country [1] 293519 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country
Australia
Secondary sponsor category [1] 292341 0
None
Name [1] 292341 0
Address [1] 292341 0
Country [1] 292341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294959 0
School of Human Movement and Nutrition Sciences, The University of Queensland Ethics
Ethics committee address [1] 294959 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
Queensland
4072
Ethics committee country [1] 294959 0
Australia
Date submitted for ethics approval [1] 294959 0
04/03/2016
Approval date [1] 294959 0
15/03/2016
Ethics approval number [1] 294959 0
HMS12/1804.R2

Summary
Brief summary
This pilot randomised controlled trial aims to develop and evaluate an innovative intervention to reduce sitting and improve activity in cancer survivors participating in clinical exercise rehabilitation. In addition to participating in the 4-week exercise clinic (1 1h session per week), half of the participants will be randomly allocated to also receive a text messaging intervention to support behaviour change outside of the face to face clinic. The 3-month intervention will consist of a suite of text messages tailored through coaching sessions conducted at baseline and 4-weeks. The primary outcome is overall sitting time (h/day) measured y the activPAL3 activity monitor. Secondary outcomes include standing time and stepping time, use of time and key clinical outcomes measured using the activPAL3, the Multimedia Activity Recall for Children and Adults (MARCA), and a clinical assessment battery, respectively. All outcomes will be measured at baseline, 4-weeks and 12-weeks. Feasibility and acceptability will also be assessed. It is hypothesised that the intervention will reduce sitting time in intervention participants compared to those that receive the exercise clinic only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65614 0
Dr Sjaan Gomersall
Address 65614 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 65614 0
Australia
Phone 65614 0
+61 7 3365 3115
Fax 65614 0
Email 65614 0
s.gomersall1@uq.edu.au
Contact person for public queries
Name 65615 0
Dr Sjaan Gomersall
Address 65615 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 65615 0
Australia
Phone 65615 0
+61 7 3365 3115
Fax 65615 0
Email 65615 0
s.gomersall1@uq.edu.au
Contact person for scientific queries
Name 65616 0
Dr Sjaan Gomersall
Address 65616 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 65616 0
Australia
Phone 65616 0
+61 3365 3115
Fax 65616 0
Email 65616 0
s.gomersall1@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
Requests for data will be considered upon reasonable request to the authors as per publication.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary