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Trial registered on ANZCTR


Registration number
ACTRN12621000634875
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
27/05/2021
Date last updated
27/05/2021
Date data sharing statement initially provided
27/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive bias modification for fear of cancer recurrence/progression
Scientific title
A randomized controlled trial of cognitive bias modification for interpretation (CBM-I) in the management of fear of cancer recurrence/progression in women with breast and ovarian cancer
Secondary ID [1] 303628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 321028 0
Ovarian cancer 321029 0
Condition category
Condition code
Cancer 318831 318831 0 0
Breast
Cancer 318832 318832 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For this study, we will adopt a double-blind randomized controlled trial methodology, whereby the cancer survivors would be randomly allocated in one of two groups:
(1) Cognitive Bias Modification intervention
(2) A placebo control.

Cognitive Bias Modification for Interpretation (CBM-I):
The Word Sentence Association Paradigm (WSAP) will be used to modify interpretation bias with word-sentence pairings training participants to make a benign interpretation of these pairings. In a typical WSAP task (Beard & Amir, 2009), each trial begins with a fixation cross for 500 ms and participants are presented with a single word (benign or threatening) followed by an ambiguous sentence, and indicate whether the two are related or not. That is, participants decide whether or not a word (e.g., embarrassing) is related to an ambiguous sentence (e.g., people laugh after something you said). Each CBM-I session would last approximately for 10-15 minutes. Some participants may be asked to rate each situation based on how worrying each situation is for them. This may take an additional 15 minutes.
The intervention will be delivered entirely online by an institutional software program (Qualtrics) that will randomly allocate participants in one of two groups.

CBM-I will be delivered four times to each participant during the entire study.
Time frame:
CBM-I training session 1: day 1 of the study
CBM-I training session 2: day 4 of the study
CBM-I training session 3: day 7 of the study
CBM-I training session 4 (FOLLOW-UP 1): day 14 of the study
The number of training sessions completed is recorded for each participant.

Intervention code [1] 319932 0
Behaviour
Comparator / control treatment
Placebo group:
Participants in the control condition will receive the same stimuli but they will be told whether they are correct on only 50% of the trials; and 50% of the trials will reinforce a benign association, while 50% will reinforce a threat interpretation. As such, the training does not influence interpretation bias, as has been repeatedly shown in the literature (Jones & Sharpe, 2017). However, this condition controls for the effect of seeing the stimuli.
Control group
Placebo

Outcomes
Primary outcome [1] 326778 0
Fear of cancer recurrence: Fear of cancer recurrence inventory (FCRI), severity subscale.
The Fear of Cancer Recurrence Inventory severity subscale (Simard & Savard, 2009) will be used to measure concerns about cancer recurrence which consists of 9 items. Each item is rated on a Likert scale ranging from ‘0’ (never) to ‘4’ (all the time). A higher score indicates higher levels of FCR.
Timepoint [1] 326778 0
Primary outcome fear of cancer recurrence (FCR) will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement, primary endpoint) and,
• Follow-up 2 (28 days post-intervention commencement)
Primary outcome [2] 326779 0
Fear of progression Questionnaire - Short Form (FoP-Q-SF).
It consists of 12 items, with response options of never (1), rarely (2), sometimes (3), often (4), and very often (5) (Herschbach et. al, 2005).
Timepoint [2] 326779 0
Primary outcome fear of progression (FoP) will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement, primary endpoint) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [1] 392655 0
Interpretation bias: We are measuring interpretation bias using the WSAP (which is the same task that is adapted for training, described above). Different items are used in the test and training phases. The test phase uses general threat stimuli to determine whether interpretation bias has been changed by the training.

Illness-related interpretive bias will be assessed through WSAP (Beard & Amir, 2009), with 118 trials of word-sentence pairings. However, no feedback will be presented here as we will measure the interpretation bias instead of providing a training. This will be done through measuring endorsement rates and reaction times for threat and benign interpretations of ambiguous sentences. For example, “Your co-workers stop talking when you enter”, if participant chooses the word “greeting”, this will be a ‘benign endorsement’ whereas, choosing word “gossip” is considered as ‘threat endorsement’. The rate of threat endorsement (percentage of threat responses) and rate of benign endorsement will be calculated to measure interpretation bias.
Timepoint [1] 392655 0

Secondary outcome interpretation bias will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [2] 392656 0
Physical Symptoms
The physical symptoms inventory (Spector & Jex, 1998) is an 18-item questionnaire where participants indicate whether or not they experience each symptom (during the past 30 days) and if they did, whether they had sought medical attention for it. Symptoms are scored as absent (0), present (1) and/or needed to seek medical attention (2) and summed.
Timepoint [2] 392656 0
Secondary outcome physical symptoms will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [3] 392657 0
Severity of pain (intensity) and its impact on daily functioning (interference).
We are using the Brief Pain Inventory. It is a self report measure and participant is instructed to report pain as an intensity and interference. The intensity scale contains 4 items measuring worst, least, and average pain intensity (usually during the past 24 h or week) and intensity now. The interference scale includes 7 items that assess pain’s interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. The response alternatives are all numerical rating scales running from 0 to 10
Timepoint [3] 392657 0
Secondary outcome severity and intensity of pain will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [4] 392658 0
Anxiety will be measured using the Hospital Anxiety and Depression Scales.
The questionnaire comprises of 7 items for anxiety.
Timepoint [4] 392658 0

Secondary outcome anxiety will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [5] 392659 0
Depression will be measured using the Hospital Anxiety and Depression Scales.
The questionnaire comprises of 7 items for depression.
Timepoint [5] 392659 0
Secondary outcome depression will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)
Secondary outcome [6] 392660 0
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) will be used to measure QoL. It has 30 items comprising distinct scales, each representing a different aspect of QoL.
Timepoint [6] 392660 0
Secondary outcome Quality of Life will be administered at following time points:
• Baseline (pre-training): before intervention/training
• Follow-up 1 (14 days post-intervention commencement) and,
• Follow-up 2 (28 days post-intervention commencement)

Eligibility
Key inclusion criteria
Inclusion criteria:
To be included patients must:
• Have a breast or ovarian cancer diagnosis
• Participants who have high levels of FCR (cut-off score of 13 or higher) or FoP (cut-off score of 34 and higher)
• 18 years and older
• Fluent in English
• Have access to internet and computer competency
• NOT receiving palliative care
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
NONE

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)
Double blind randomised controlled trial.

The software program ‘Qualtrics’ will be used as a platform to deliver the training, as well as the questionnaires, information statement, consent and debrief. Qualtrics has an inbuilt randomisation function, which will electronically allocate each participant to one of 2 groups. This way the trial manager will also remain blind to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation. In this case Qualtrics, a web based software will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STATISTICAL METHODS

Sample size estimation:
The rationale behind the sample size is that Lichtenthal et al (2017) study obtained an effect size of Hedge’s g = 0.25 between the intervention and control condition at two time points (baseline levels and after administering the intervention). Assuming a similar effect size, we need at least 165 participants to have 80% power to detect this between groups difference.

Statistical Analysis plan:
We intend to perform a series of linear mixed model regressions (LMMR) in order to examine the effect of time; intervention group and group x time on the dependent variables. We will use LMMR to impute missing data for intention to treat analyses. However, since this is a remotely delivered intervention and we anticipate a drop-out. of about one third from our previous studies, we will also conduct a per protocol analysis.

We would then do a mediation analyses in PROCESS to determine whether (when controlling for baseline levels of the outcome), changes in interpretation bias mediate the relationship between group assignment and FCRI/FoPQ at the final follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
15/03/2022
Actual
Date of last data collection
Anticipated
15/04/2022
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308049 0
Self funded/Unfunded
Name [1] 308049 0
Poorva Pradhan
Country [1] 308049 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Camperdown, NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 308797 0
None
Name [1] 308797 0
Address [1] 308797 0
Country [1] 308797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308041 0
Sydney University Human Research Ethics Committee (HREC)
Ethics committee address [1] 308041 0
Research Integrity and Ethics Administration
Level 3, Administration Building (F23)
The University of Sydney
Camperdown
NSW 2006
Ethics committee country [1] 308041 0
Australia
Date submitted for ethics approval [1] 308041 0
20/11/2020
Approval date [1] 308041 0
25/01/2021
Ethics approval number [1] 308041 0
2020/835

Summary
Brief summary
This trial aims to determine the effect of cognitive bias modification on fear of cancer recurrence or progression in patients with breast and ovarian cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or above, have been diagnosed with a breast or ovarian cancer (unless you are receiving palliative care), and are currently struggling with a fear of cancer recurrence or progression.

Study details
Participants will be randomly allocated (by chance) to receive cognitive bias modification training (CBM) or a placebo. . CBM is an intervention that is administered online and trains people not to interpret ambiguous situations in a threatening way. Participants will receive four cognitive bias modification sessions over the duration of 14 days and will be required to answer a number of questionnaires before the trial, and both 14 and 28 days after the trial has commenced.

It is hoped that this study may demonstrate that cognitive bias modification is effective in reducing fear of cancer recurrence and progression in patients with breast and ovarian cancer, and may help to reduce pain, anxiety, and depression, and improve quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109314 0
Prof Louise Sharpe
Address 109314 0
Room BM 450
Brennan MacCallum, A18
The University of Sydney
Camperdown
NSW 2006
Country 109314 0
Australia
Phone 109314 0
+61 2 9351 4558
Fax 109314 0
Email 109314 0
[email protected]
Contact person for public queries
Name 109315 0
Miss POORVA PRADHAN
Address 109315 0
Room 466, Griffith Taylor (A19)
School of Psychology
THE UNIVERSITY OF SYDNEY
Camperdown
NSW 2006
Country 109315 0
Australia
Phone 109315 0
+61481863255
Fax 109315 0
Email 109315 0
[email protected]
Contact person for scientific queries
Name 109316 0
Prof Louise Sharpe
Address 109316 0
Room BM 450
Brennan MacCallum, A18
The University of Sydney
Camperdown
NSW 2006
Country 109316 0
Australia
Phone 109316 0
+61 2 9351 4558
Fax 109316 0
Email 109316 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.