Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000131358
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
24/01/2017
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Wearable Activity Technology And Action-Planning (WATAAP) trial to promote physical activity in colorectal and endometrial cancer survivors at cardiovascular risk
Scientific title
Wearable Activity Technology And Action-Planning (WATAAP) trial to promote physical activity in colorectal and endometrial cancer survivors at cardiovascular risk
Secondary ID [1] 290918 0
None
Universal Trial Number (UTN)
U1111-1191-6268
Trial acronym
WATAAP (Wearable Activity Technology And Action-Planning) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 301639 0
cardiovascular risk 301640 0
Condition category
Condition code
Cancer 301340 301340 0 0
Womb (Uterine or endometrial cancer)
Cancer 301341 301341 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 301342 301342 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm will receive a Fitbit to use to monitor physical activity for the duration of the 12-week intervention. Participants who are randomised to the intervention arm will also attend two group sessions which will target goal-setting and action-planning skills.

The treatment group will be able to collect the Fitbit post-randomisation. Participants will be able to pick the Fitbit up from the hospital, signing it out upon collection at their first group meeting. They will be asked to wear the Fitbit as much as possible during the 12-week intervention (at least 8 hours per day, preferably all waking hours), and will be encouraged to download Fitbit software that will assist in tracking their physical activity. Use of the Fitbits will provide participants with a practical and convenient method for monitoring their activity.
Throughout the 12-week intervention, participants in the treatment group will be required to attend two 1-hour group sessions. The first group session will be held in week 1, and the second in week 4 of the study. Session one will focus on introducing participants to the Fitbit and giving instructions on how to use this device as a self-monitoring tool. Participants will complete goal-setting worksheets (Appendix F - attached to ANZCTR registration form) to set their activity goals for the following 12 weeks. Behaviour change specialists SH and CMS will assist participants with effective action planning, goal-setting and self-monitoring.
Session two will attend to support needs and help participants to plan for and overcome barriers to increasing their physical activity level. Participants will also be able to adjust previously established goals, if necessary. This session will also allow for trouble-shooting of any problems or queries that participants encounter regarding Fitbit wear and use.
Participants will take all worksheets from the sessions home with them, to assist with achieving their goals. At the end of the 12-week intervention, all participants should have completed two group sessions. Although this is not required, it is recommended that participants will also meet and build rapport with other participants in their neighbourhood outside of the meetings to boost their support and provide a sense of accountability. A final booster message will be sent to participants via text message or email (according to participant preference) at week 6. In keeping with the theme of self-monitoring and support needs, this booster message will contain a brief note of encouragement and a recommendation to track physical activity, with the aim of meeting the government guidelines. Participants will attend their end of intervention assessment at 12 weeks. At 24 weeks (twelve weeks post-intervention), participants will attend their final follow-up assessment. Participants will be required to return their Fitbit within the fortnight following the 24-week intervention. Following completion of the trial, participants will be invited to give feed back on effective components of the intervention via semi-structured interviews.
Intervention code [1] 296855 0
Behaviour
Intervention code [2] 296856 0
Lifestyle
Comparator / control treatment
Control participants will receive printed information on the government guidelines for physical activity, making physical activity goals, and action planning, at baseline (Appendix E - attached to ANZCTR registration form). These resources are comparable to the generic recommendations that cancer survivors have reported receiving post-treatment (Maxwell-Smith, Zeps, Hagger, Platell & Hardcastle, 2016), and therefore represent a usual care condition. In addition to these print materials, participants will also receive goal-setting and problem solving worksheets (Appendix F- attached to ANZCTR registration form). These materials will be identical to those that will be given to the treatment group during group sessions. However, members of the research team will not direct the control group or engage with them regarding the activities. Participants will receive a booster text message or email at 6 weeks. For the control group, this message will be a reminder of the Australian Government's Department of Health guidelines for physical activity and encourage participants to aim for these recommendations. Participants will undergo the end of intervention assessment at 12 weeks, and their final follow-up assessment at 24 weeks (12 weeks post-intervention). The control group will not receive a Fitbit to assist with self-monitoring of activity during the 12-week intervention. Upon completion of the study at 24 weeks post-enrolment, participants from the control group will be given the opportunity to trial the Fitbit for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300787 0
Minutes of activity per week as measured by accelerometer wear for 7 days.
Timepoint [1] 300787 0
12 weeks after baseline
Primary outcome [2] 300788 0
Minutes of sedentary time as measured by accelerometer wear for 7 days.
Timepoint [2] 300788 0
12 weeks after baseline.
Secondary outcome [1] 330848 0
Minutes of physical activity per week as measured by accelerometer wear for 7 days.
Timepoint [1] 330848 0
24 weeks after baseline.
Secondary outcome [2] 330849 0
Minutes of sedentary time as measured by accelerometer wear for 7 days.
Timepoint [2] 330849 0
24 weeks after baseline.
Secondary outcome [3] 330850 0
Quality of life as measured by MOS-SF.
Timepoint [3] 330850 0
12 weeks after baseline.
Secondary outcome [4] 330861 0
Physical activity MET minutes per week as measured by IPAQ-SF.
Timepoint [4] 330861 0
12 weeks post baseline.
Secondary outcome [5] 330862 0
Physical activity MET minutes per week as measured by IPAQ-SF.
Timepoint [5] 330862 0
24 weeks post baseline.
Secondary outcome [6] 330863 0
BMI as measured by weight & height, which will be assessed by study investigators at hospital using scales.
Timepoint [6] 330863 0
12 weeks post baseline.
Secondary outcome [7] 330864 0
BMI as measured by weight & height, which will be assessed by study investigators at hospital using scales.
Timepoint [7] 330864 0
24 weeks after baseline.
Secondary outcome [8] 345279 0
Effectiveness of intervention based on semi-structured qualitative interview feedback.
Interviews will be guided by the following questions:
• Thank you very much for participating in the project, please could you tell me a bit about how you got on with the project?
• Which aspects of the projects were most useful/less useful? And why?
• What did you learn or achieve from participating in the project?
• Did you achieve your goals? What were they?
• There were several components to the project; the Fitbit Alta device, the APP, the group sessions, the booklet containing action planning sheets, goal-setting sheets etc.; we’re keen to understand which aspects were the most effective or least effective for increasing your physical activity?
• Interviewer to check whether participants understood/took in the importance of ‘intensity’ and 10-minute bouts over the steps message. ‘What was the main message concerning how much physical activity you should be doing in a day or week’?
• In an ideal world, what would the perfect exercise project look like? What kind of support do you feel would be the most effective? How could the project be improved And why?
• You’ve had to give back the Fitbit that you have for 6-months; did you buy your own? How are you getting on now in terms of your physical activity level? Are you measuring your physical activity progress?
• Did you during the project or are you now doing any of the strength-based exercises that Sarah and Chloe demonstrated or those contained in the booklet?
• What are the main influences on your physical activity level?
• What are the main barriers to maintaining or achieving a physically active lifestyle?
• Have you received any advice/support from the oncology team re: the importance of physical activity? If yes then what have you been advised and what resources have you been given?
• Do you have any further comments or questions?
Thanks for your time.
Timepoint [8] 345279 0
It is anticipated that all interviews will be conducted within two months of trial completion.

Eligibility
Key inclusion criteria
1) Gynaecological or colorectal cancer survivors undergoing follow-up at St. John of God Subiaco Hospital, WOMEN Centre in West Leederville, and Hollywood Private Hospital in Nedlands, Western Australia.
2) Patients have completed active cancer treatment (surgery and/or radiotherapy and/or chemotherapy) within the last 5 years (excluding hormone therapy).
3) Have comorbidities resulting in increased CVD risk, as identified through hospital medical records (i.e., on blood pressure medication or have blood pressure >150/90mm Hg, BMI >28, hypercholesterolemia >5.2mmol/L), OR an American Society of Anaesthesiologists (ASA) score of 2 or 3 (in the absence of appropriate medical records).
4) Are in remission at the time of recruitment.
5) Are aged 18-80 years at recruitment.
6) Are English-reading and speaking.
7) Live locally within 100km of Perth.
8) Have no surgery planned during the 6 months following recruitment.
9) Are willing and able to give informed consent to participate in the study.
10) Are willing to maintain contact with the investigators for the 6 months following recruitment.
As described above in criteria 3), comorbidity will be assessed using available medical records of BMI, blood pressure and cholesterol. In the absence of this data, individuals will be recruited based on their ASA score at time of treatment. Only those with an ASA score of 2 or 3 will be eligible for recruitment. An ASA score from 1-4 is assigned to patients upon admission to hospital for a surgical procedure. A low ASA score indicates that the patient is at minimal cardiovascular risk, and a higher ASA score suggests that the patient suffers from comorbidities that may pose a threat to their life. Participants with ASA scores of 2 or 3 will have comorbidities such as hypertension, hypercholesterolemia, hyperlipidaemia, and elevated BMI, putting them at risk of CVD. The ASA score is globally recognised as an indicator of physical health status of patients prior to undergoing surgery (Owens, Felts & Spitznagel, 1978).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Undergoing treatment for cancer.
2) Have completed cancer treatment >5 years prior to recruitment.
3) Have an ASA score of 1 or 4.
4) Are younger than 18 years or older than 80 years of age.
5) Have recurrent or metastatic disease.
6) Have a diagnosis of a severe psychiatric illness.
7) Have cardiac abnormalities including unstable angina or recent myocardial infarction.
8) Have any severe disability that may affect physical function including severe arthritis.
9) Are currently enrolled in a health behaviour trial or program such as Weight Watchers.
Individuals who have been diagnosed with uterine carcinosarcoma (MMMT), uterine serous carcinoma, or ovarian cancer will be excluded during the screening process. These cancer subtypes are typically associated with a poor prognosis. By excluding these subtypes, we hope to avoid attempting to contact individuals who may be deceased.
Individuals with an ASA score of 1 are unlikely to benefit from the project as it is expected that cardiovascular health improvements will be minimal in patients who are already in good health. Additionally, those with an ASA score of 1 do not fall into the target sample of ‘cancer survivors at high cardiovascular risk’. Individuals with an ASA score of 4 are considered to have significant life threatening comorbidities, deeming the intervention inappropriate for this group.

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)
Participants will be screened for eligibility to be recruited into the trial by the PI. An independent statistician will then randomise eligible individuals into treatment and control groups. Therefore allocation will be concealed from the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed by an independent statistician. Participants will be randomly allocated using 1:1 allocation in blocks of 4. The order of allocation is random within each block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations suggest that a sample size of 56 is sufficient to detect a significant difference in physical activity between intervention and control groups. According to G*Power, at an alpha level of .05, 56 participants (28 per group) will provide an 80% chance of capturing a ‘small to moderate’ group x time interaction. We aim to recruit 64 participants into the trial to allow for loss to follow-up. This ensures that, even if 12% are lost to follow-up, the intervention will still be adequately powered at 80% to detect a meaningful change. A dropout rate of 12% is a reasonable estimation, given previous dropout rates of around 10% in 3-month and 6-month health behaviour interventions for cancer survivors (Lahart et al., 2016; Rogers et al., 2009; Short et al., 2015).
Therefore, participants will be randomized into treatment (N=32) and control (N=32) groups following baseline assessment.


The analysis will be a mixture of quantitative and qualitative approaches. Quantitative data will be analysed in the statistical software program, SPSS version 24, to establish the overall distribution and trends within the data. A Generalised Linear Mixed Model (GLMM) analysis will allow us to examine between-group physiological and psychological differences that could be attributed to the effect of the behavioural intervention. The primary outcome variable will be physical activity per week, pre- and post-intervention. The group x time interaction will display any intervention effect. According to G*Power, at an alpha level of .05, our sample of 56 participants (28 per group) will provide an 80% probability of capturing a small to moderate (f = .17) interaction. Qualitative data from the 24-week follow-up will be analysed using inductive thematic analysis to identify common themes associated with feedback and feasibility.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2017
Actual
9/08/2017
Date of last participant enrolment
Anticipated
15/09/2017
Actual
16/09/2017
Date of last data collection
Anticipated
1/05/2018
Actual
30/04/2018
Sample size
Target
64
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7336 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 7337 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 15122 0
6008 - Subiaco
Recruitment postcode(s) [2] 15123 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 295373 0
Other Collaborative groups
Name [1] 295373 0
Gynaecological research group at WOMEN centre, St. John of God
Country [1] 295373 0
Australia
Primary sponsor type
Hospital
Name
St. John of God Subiaco Hospital
Address
12 Salvado Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 294196 0
University
Name [1] 294196 0
Curtin University
Address [1] 294196 0
Kent St
Bentley
WA 6102
Country [1] 294196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296707 0
St. John of God Human Research Ethics Committee
Ethics committee address [1] 296707 0
Ethics committee country [1] 296707 0
Australia
Date submitted for ethics approval [1] 296707 0
30/12/2016
Approval date [1] 296707 0
08/02/2017
Ethics approval number [1] 296707 0
1102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1375 1375 0 0
/AnzctrAttachments/372166-Intervention Ethics Protocol.docx (Protocol)
Attachments [2] 1376 1376 0 0
/AnzctrAttachments/372166-Appendix A Schematic of Intervention Design.doc (Supplementary information)
Attachments [3] 1377 1377 0 0
/AnzctrAttachments/372166-Appendix B Quantitative Assessment.docx (Supplementary information)
Attachments [4] 1378 1378 0 0
/AnzctrAttachments/372166-Appendix C Qualitative Feedback.docx (Supplementary information)
Attachments [5] 1379 1379 0 0
/AnzctrAttachments/372166-Appendix D Intervention Invitation Letter.doc (Supplementary information)
Attachments [6] 1380 1380 0 0
/AnzctrAttachments/372166-Appendix E Physical Activity Booklet.docx (Supplementary information)
Attachments [7] 1381 1381 0 0
/AnzctrAttachments/372166-Appendix F Worksheet.docx (Supplementary information)
Attachments [8] 1382 1382 0 0
/AnzctrAttachments/372166-Intervention PICF.docx (Participant information/consent)
Attachments [9] 1455 1455 0 0
/AnzctrAttachments/372166-#1102FinalApproval08022017.pdf (Ethics approval)

Contacts
Principal investigator
Name 71722 0
Miss Chloe Maxwell-Smith
Address 71722 0
School of Psychology & Speech Pathology
Faculty of Health Sciences
Curtin University
Kent st
Bentley WA 6102
(please use email address)
Country 71722 0
Australia
Phone 71722 0
+61 449 768 269
Fax 71722 0
Email 71722 0
Chloe.maxwell-smith@curtin.edu.au
Contact person for public queries
Name 71723 0
Chloe Maxwell-Smith
Address 71723 0
School of Psychology & Speech Pathology
Faculty of Health Sciences
Curtin University
Kent st
Bentley WA 6102
(please use email address)
Country 71723 0
Australia
Phone 71723 0
+61 449 768 269
Fax 71723 0
Email 71723 0
Chloe.maxwell-smith@curtin.edu.au
Contact person for scientific queries
Name 71724 0
Sarah Hardcastle
Address 71724 0
School of Psychology & Speech Pathology
Faculty of Health Sciences
Curtin University
Kent St
Bentley
WA 6102
Country 71724 0
Australia
Phone 71724 0
+61 439 226 015
Fax 71724 0
Email 71724 0
sarah.hardcastle@curtin.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
1573Study protocol    372166-(Uploaded-11-03-2019-21-38-04)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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