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Trial registered on ANZCTR
Registration number
ACTRN12625000906459
Ethics application status
Approved
Date submitted
22/07/2025
Date registered
20/08/2025
Date last updated
20/08/2025
Date data sharing statement initially provided
20/08/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Testing the feasibility, acceptability and impact of an online delivered stress management program for Australian with breast and colorectal cancer
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Scientific title
Testing the feasibility, acceptability and impact of an online delivered stress management program for Australian with breast and colorectal cancer: a pilot study
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Secondary ID [1]
314809
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Nil known
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Universal Trial Number (UTN)
U1111-1324-8582
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
breast cancer
338062
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colorectal cancer
338063
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Condition category
Condition code
Cancer
334355
334355
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0
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Breast
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Cancer
334356
334356
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
334357
334357
0
0
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Bowel - Small bowel (duodenum and ileum)
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Cancer
334358
334358
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0
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Bowel - Anal
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Mental Health
334818
334818
0
0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cognitive Behavioural Stress Management (CBSM) intervention. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. Each session will be divided into three segments: i) an initial discussion (20 minutes), ii) cognitive behavioural therapy (CBT) components (40 minutes), and iii) relaxation techniques (40 minutes). Each group will include 4-5 people. First session: stress definition, appraisal process explanation, and 7 groups of progressive muscle relaxation. Second session: Automatic thoughts, cognitive distortions, deep breathing, 4 groups of progressive muscle relaxation, and guided imagery "Beach Scene". Third session: coping strategies, softening, deep breathing, and guided imagery "Special Place Imagery". Fourth session: Interpersonal Support and anger management, progressive muscle relaxation, and guided imagery "Light imagery". Fifth session: assertiveness training and meditation.
After attending the first session, participants will have access to a website where information about the content of each week’s session is shared, as well as a recording to practice the relaxation technique learned during each session. Participants will be encouraged to practice between sessions to enhance the effectiveness of the relaxation techniques and reinforce these new skills. Participants are encouraged to practice at least one relaxation technique between sessions. Each practice session typically lasts around 20 minutes. However, engaging in this practice is entirely up to the participant; choosing not to do so will not result in exclusion from the program. Additionally, the program’s website provides supplementary materials (e.g., slide presentations) summarising the content discussed in each session. These resources are intended to support participants who may experience side effects from cancer treatment and, therefore, require more time to focus on specific topics. The use of these materials is optional and depends entirely on each participant’s preferences and needs.
The intervention is delivered by A.V., a PhD student who has received training and ongoing support from the developer of the CBSM program. As this is not a therapeutic program, the facilitator is not required to be a registered psychologist or psychotherapist.
Adherence to the intervention will be assessed through a combination of attendance records and engagement with program materials. Specifically, the facilitator will record participants' attendance at each of the five weekly online group sessions. If a participant is unable to attend a session, they will be offered a shorter individual session to review the content they missed. This approach is intended to maintain intervention fidelity and support the participant in rejoining the group the following week. Usage data from the program website will be monitored at the beginning of each session to assess participants' interaction with the intervention content. If a participant is not engaging with the materials as expected, the facilitator will follow up to discuss any barriers they may be experiencing and explore potential solutions to support their continued involvement
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Intervention code [1]
331407
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Treatment: Other
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Comparator / control treatment
Participants assigned to the control group will be contacted via email at week 1 and week 3 of the intervention period and provided with contact details of support organisations they can contact (e.g., Cancer Council Victoria, Breast Cancer Network Australia, Bowel Cancer Australia). This strategy aims to keep control participants engaged in the study until the end of the CBSM intervention and to understand the role of a low-involvement approach on patients’ well-being. After completing the last survey (3 months after the end of the intervention) they will be able to access the study website to obtain information about the stress management intervention and practice the relaxation techniques.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Feasibility will be assessed via recruitment and completion rates. Recruitment and completion rates will be obtained from an audit of study records, utilising Qualtrics data for recruitment and attendance logs for completion.
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Timepoint [1]
342047
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Upon conclusion of the study
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Primary outcome [2]
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Acceptability
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Assessment method [2]
342455
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Semi-structured interview. The interview will be conducted within the weeks following completion of the 5-week intervention. Participants will be able to choose the day and time according to their preference. Examples of questions used to assess the acceptability of the intervention include: When you were recruited, what were your first thoughts and opinions about the program?, Focusing on the online group sessions, what do you think about them?, Have you used the website? What do you think about it?.
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Timepoint [2]
342455
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Upon conclusion of the intervention—specifically, within the two weeks following the fifth session—interviews will be conducted.
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Secondary outcome [1]
449413
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Stress level
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Assessment method [1]
449413
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Perceived Stress Scale -10
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Timepoint [1]
449413
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [2]
449414
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Intervention's effects
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Assessment method [2]
449414
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Measure of Current Status (Part A and Part B)
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Timepoint [2]
449414
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [3]
449415
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Anxiety
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Assessment method [3]
449415
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Hospital Anxiety Depression Scale
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Timepoint [3]
449415
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [4]
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Health related quality of life
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Assessment method [4]
449416
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Functional Assessment of Cancer Therapy - General, version 4 (27 items)
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Timepoint [4]
449416
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [5]
449417
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Coping Strategies
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Assessment method [5]
449417
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Brief Coping Orientation to Problems Experienced
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Timepoint [5]
449417
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [6]
449418
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Illness Perception
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Assessment method [6]
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Brief Illness Perception Questionnaire
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Timepoint [6]
449418
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [7]
449419
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Stress perception and management (this will be assessed as a composite outcome)
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Assessment method [7]
449419
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Sense of Coherence (13-item version)
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Timepoint [7]
449419
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [8]
449420
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Social support
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Assessment method [8]
449420
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Social Provision Scale (10-item version)
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Timepoint [8]
449420
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [9]
450870
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Depression
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Assessment method [9]
450870
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Hospital Anxiety Depression Scale
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Timepoint [9]
450870
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Secondary outcome [10]
450872
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Psychological Distress
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Assessment method [10]
450872
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Hospital Anxiety Depression Scale
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Timepoint [10]
450872
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Baseline (pre-intervention), post-completion of 5-week intervention, and 3 months after the end of the 5-week intervention
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Eligibility
Key inclusion criteria
a) a diagnosis of breast or colorectal cancer (Stage I, II or III),
b) aged 18 years old or older,
c) currently receiving any cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy),
d) having access to an internet-connected device (e.g., computer, tablet PC),
e) capacity to consent to the study,
f) willing to participate in a 5-week group program and engage in program activities,
g) able to read and speak English.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
a) severe cognitive impairment, thus, unable to provide consent,
b) a previous history of cancer or multiple primary cancers,
c) recurrence of cancer,
d) receiving non-curative treatment.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation). The allocation sequence was generated in a 4-block permutation by a blinded statistician prior to recruitment.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive characteristics will be conducted. Frequencies will be used to assess uptake and retention rates, determining the feasibility of the intervention. Generalised estimating equations (GEE) will be used to examine the potential impact of the secondary outcomes – stress, anxiety and depressive symptoms, quality of life, coping skills, illness representation, sense of coherence, and social support. In these analyses, after including the main effects for group and time, the statistical significance of the interaction of time by group will be tested to explore the impact of the intervention. GEE will be conducted to test the effect of the intervention at the end of the intervention and then at the 3-month follow-up.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
27/12/2024
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Date of last participant enrolment
Anticipated
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Actual
10/06/2025
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Date of last data collection
Anticipated
26/11/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
319366
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University
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Name [1]
319366
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Deakin University
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Address [1]
319366
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Country [1]
319366
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
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Country
Australia
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Secondary sponsor category [1]
321861
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None
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Name [1]
321861
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Address [1]
321861
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Country [1]
321861
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317942
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Barwon Health HREC
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Ethics committee address [1]
317942
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http://www.barwonhealth.org.au/research/column-1/regi
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Ethics committee country [1]
317942
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Australia
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Date submitted for ethics approval [1]
317942
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22/03/2024
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Approval date [1]
317942
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08/08/2024
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Ethics approval number [1]
317942
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Summary
Brief summary
The primary objective of this pilot randomised controlled trial is to assess the feasibility and acceptability of a new, 5-week, group-based online-delivered stress management program for Australian with breast and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult diagnosed with breast or colorectal cancer (Stage I, II, or III) and are currently undergoing cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy). Study details Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. They will also have access to a study website, which will contain summaries of the sessions and guidance on relaxation techniques. Participants in the control group will receive information on support networks they can access, and following completion of the study period, will receive access to the study website. It is hoped that the findings from this study will help researchers evaluate the feasibility and acceptability of an online stress management program for cancer patients and guide the design of future larger trials.
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Trial website
https://cbsmstudy.squarespace.com/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
142634
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Prof Victoria White
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Address
142634
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221 Burwood Highway, Burwood, Melbourne, VIC 3125
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Country
142634
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Australia
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Phone
142634
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+61 392468522
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Fax
142634
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Email
142634
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[email protected]
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Contact person for public queries
Name
142635
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Victoria White
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Address
142635
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221 Burwood Highway, Burwood, Melbourne, VIC 3125
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Country
142635
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Australia
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Phone
142635
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+61 392468522
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Fax
142635
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Email
142635
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[email protected]
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Contact person for scientific queries
Name
142636
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Victoria White
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Address
142636
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221 Burwood Highway, Burwood, Melbourne, VIC 3125
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Country
142636
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Australia
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Phone
142636
0
+61 392468522
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Fax
142636
0
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Email
142636
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Participants were informed in the plain language statement that their data would remain confidential, analysed in de-identified form, and reported only in combination with data from other participants. The nature of this study — a small-scale feasibility trial — means that individual-level data would not be scientifically informative on their own. Therefore, there is no plan to share individual participant data.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
080824_Letter.pdf
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.
Download to PDF