Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000288325
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
24/02/2017
Date last updated
3/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a visualisation intervention to improve recovery behaviours following colorectal and gynaecological oncology surgery
Scientific title
The use of a visualisation intervention to improve recovery behaviours following colorectal and gynaecological oncology surgery
Secondary ID [1] 291195 0
none
Universal Trial Number (UTN)
U1111-1193-1685
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer Surgery 302098 0
Gynaecological Oncology Surgery 309486 0
Condition category
Condition code
Cancer 301722 301722 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 301794 301794 0 0
Other surgery
Cancer 308320 308320 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study includes 3 conditions, two of which are intervention arms: the visualisation intervention and a verbal information only group (active control). The final group is a standard care group. The intervention group will receive an animated intervention depicting the purpose of the recovery behaviours of early re-mobilisation and the early re-introduction of food and drink following surgery. These animations will be displayed on an iPad and shown to patients at their bedside at day 1 following their surgery and takes approximately 10 minutes to deliver.. The intervention will be administered by the student researcher (Annie Jones, PhD student in Health Psychology). The intervention will provide information about how these two behaviours (which are part of the standard Enhanced Recovery After Surgery programme which all patients undergo) will help the patient to recover faster from their surgery. There are two versions of the intervention where either a male or female actor patient is used. The version of the intervention the patient sees will be their gender match. The intervention will begin by highlighting common beliefs that patients have about recovering from a surgical procedure, such as ideas around bed rest being the fastest way to heal. These ideas will be challenged by providing information about the ERAS programme including evidence from previous clinical trials. The intervention then explains the recovery behaviour of early mobilisation. The presentation incorporates real life footage of an ‘actor’ with animations depicting the internal bodily processes occurring while either resting, or when mobile. The animations show the heart, the lungs, and bodily circulation. The second part of the intervention shows the importance of the early re-introduction of food and drink following surgery. An animation explaining the digestive system is used here. The intervention also outlines to patients their daily goals for each of the behaviours. These are pre-existing goals that are given to all patients in their information booklet. Finally, the intervention ends with an elaborative reasoning task, which tries to get the patient to contextualise their ideas about exercising with their own life. The patient is asked to discuss two questions: “In what ways could you incorporate exercise into something specific that you might do on the ward while in hospital?” and “In what specific ways can you try and incorporate daily exercise into your routine once you are discharged and back home?”.
Intervention code [1] 297197 0
Behaviour
Intervention code [2] 297231 0
Treatment: Other
Comparator / control treatment
One of the three arms of the study is a standard care group. This group will receive standard hospital care following their surgery. This group will complete the baseline questionnaire prior to their surgery, and also be visited at day 1 following their surgery. At this time point, this group will only complete the second study questionnaire and be fitted with a fitness tracker watch the same as all study participants. These participants will also wear this watch until 1 week post-discharge and also complete the final telephone questionnaire at this time-point

The study also includes an active control group. This group of participants will receive standard care plus the exact same verbal script that participants in the intervention group receive, but without seeing the iPad animations. The purpose of this group is to control of the provision of information and assess the effectiveness of the visualisation over and above standard verbal delivery of the same information.
Control group
Active

Outcomes
Primary outcome [1] 301116 0
Step count as measured by a fitness tracker watch.
Timepoint [1] 301116 0
Day 1 following surgery to 1 week post-discharge
Secondary outcome [1] 331763 0
Recovery behaviour beliefs. These are assessed using a 6 items on our baseline, post procedure and follow-up questionnaires. These items are rated on a 10 item likert scale with questions such as "How motivated are you to be active immediately following your surgery?" and "How anxious do you feel about being mobile during your recovery?". These items were designed specially for this study,
Timepoint [1] 331763 0
Baseline (pre-surgery), Day 1 following surgery and 1 week post-discharge.
Secondary outcome [2] 332017 0
Illness perceptions. These items have been adapted from the Brief Illness Perception Questionnaire (Broadbent, Petrie, Main, & Weinman, 2006) to ask about surgery and recovery, questions regarding understanding, anxiety, and motivation to perform the recovery behaviours, and some questions regarding their beliefs about recovery from surgery.
Timepoint [2] 332017 0
Baseline (pre-surgery), Day 1 following surgery and 1 week post-discharge.
Secondary outcome [3] 332018 0
Self-reported exercise. A single item is used to ask participants to report "In the past 7 days, how many minutes did you spend doing moderate exercise (e.g. going for a walk)?".
Timepoint [3] 332018 0
Baseline (pre-surgery) and at follow-up (1 week post-discharge)

Eligibility
Key inclusion criteria
Patients will be included in the study if they are undergoing colorectal or gynaecological oncology surgery at Auckland City Hospital during our recruitment period (July 2017-July 2018), over the age of 18.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they feel unable to complete the questionnaires and if they cannot understand English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomly allocated into one of the three study arms before completing the second study session (after already completing baseline assessment). This randomisation will be created by someone independent of the study and sealed in opaque, numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be conducted using a computer website "Research Randomizer".
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
We are aiming to recruit 90 participants for the current study (30 participant in each study arm). This is based off a G*Power calculation which suggested that 81 participants would be required using a repeated measures between-within ANOVA to measure differences with 80% power at a significance level of p= .05 with a small to medium effect size (f= 0.18). This effect size was taken from a previous study for testing differences between groups over time in levels of Brief IPQ understanding (Jones, Fernandez, Grey, & Petrie, In Submission). We are aiming for 90 participants to account for a possible 10% attrition rate.

Repeated-measures between-within ANOVA will be used to assess differences between study groups, from baseline to post-surgery (and 1-week follow-up where applicable), in recovery beliefs, illness perceptions and anxiety and motivations to perform recovery behaviours. Repeated measures ANOVA will be used to assess differences in self-reported exercise levels between study groups from baseline to 1-week follow-up. A one-way ANOVA will be used to assess differences in total step count between the two groups. Independent samples t-tests and Chi-Square tests for independence will be used to assess difference between groups in demographic variables and baseline measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2017
Actual
19/07/2017
Date of last participant enrolment
Anticipated
1/06/2018
Actual
19/07/2018
Date of last data collection
Anticipated
1/07/2018
Actual
10/08/2018
Sample size
Target
90
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8670 0
New Zealand
State/province [1] 8670 0
Auckland

Funding & Sponsors
Funding source category [1] 295640 0
University
Name [1] 295640 0
University of Auckland - Postgraduate Research Student Support Account
Country [1] 295640 0
New Zealand
Primary sponsor type
Individual
Name
Keith Petrie
Address
Department of Psychological Medicine,
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 294481 0
None
Name [1] 294481 0
Address [1] 294481 0
Country [1] 294481 0
Other collaborator category [1] 279433 0
Individual
Name [1] 279433 0
Annie Jones
Address [1] 279433 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 279433 0
New Zealand
Other collaborator category [2] 279434 0
Individual
Name [2] 279434 0
Dr Justin Fernandez
Address [2] 279434 0
Auckland Bioengineering Institute
University of Auckland
Private bag 92019
Auckland 1142
Country [2] 279434 0
New Zealand
Other collaborator category [3] 279435 0
Individual
Name [3] 279435 0
Dr Arend Merrie
Address [3] 279435 0
Department of General Surgery
Auckland City Hospital
Private bag 92024
Auckland 1142
Country [3] 279435 0
New Zealand
Other collaborator category [4] 279436 0
Individual
Name [4] 279436 0
Annelies Mittendorf
Address [4] 279436 0
Department of General Surgery
Auckland City Hospital
Private bag 92024
Auckland 1142
Country [4] 279436 0
New Zealand
Other collaborator category [5] 280330 0
Individual
Name [5] 280330 0
Dr Lois Eva
Address [5] 280330 0
Gynaecological Oncology Department, National Women’s Health, Private Bag 92024,
Auckland 1142, New Zealand
Country [5] 280330 0
New Zealand
Other collaborator category [6] 280331 0
Individual
Name [6] 280331 0
Penny Bognude
Address [6] 280331 0
Gynaecological Oncology Department, National Women’s Health, Private Bag 92024,
Auckland 1142, New Zealand
Country [6] 280331 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296957 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 296957 0
Ethics committee country [1] 296957 0
New Zealand
Date submitted for ethics approval [1] 296957 0
23/02/2017
Approval date [1] 296957 0
06/04/2017
Ethics approval number [1] 296957 0
Ethics committee name [2] 296959 0
Auckland District Health Board Ethics Committee
Ethics committee address [2] 296959 0
Ethics committee country [2] 296959 0
New Zealand
Date submitted for ethics approval [2] 296959 0
02/03/2017
Approval date [2] 296959 0
19/05/2017
Ethics approval number [2] 296959 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1459 1459 0 0
/AnzctrAttachments/372370-CRC surgery study - Study Protocol 16.02.2017.docx (Protocol)

Contacts
Principal investigator
Name 72538 0
Prof Keith Petrie
Address 72538 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 72538 0
New Zealand
Phone 72538 0
+6421 111 7222
Fax 72538 0
Email 72538 0
[email protected]
Contact person for public queries
Name 72539 0
Keith Petrie
Address 72539 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 72539 0
New Zealand
Phone 72539 0
+6421 111 7222
Fax 72539 0
Email 72539 0
[email protected]
Contact person for scientific queries
Name 72540 0
Keith Petrie
Address 72540 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 72540 0
New Zealand
Phone 72540 0
+6421 111 7222
Fax 72540 0
Email 72540 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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