Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001644156p
Ethics application status
Not yet submitted
Date submitted
19/11/2019
Date registered
25/11/2019
Date last updated
6/04/2020
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Based Acceptance and Commitment Therapy (ACT) for Improving Wellbeing following Primary Medical Intervention for Breast Cancer: A Follow-up Randomised Control Trial
Scientific title
Group Based Acceptance and Commitment Therapy (ACT) for Improving Wellbeing following Primary Medical Intervention for Breast Cancer: A Follow-up Randomised Control Trial
Secondary ID [1] 299847 0
Nil known
Universal Trial Number (UTN)
U1111-1243-8741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 315240 0
Wellbeing 315241 0
Condition category
Condition code
Cancer 313547 313547 0 0
Breast
Mental Health 313548 313548 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will receive 6 x 1.5 hr group-based Acceptance and Commitment Therapy delivered weekly by one psychologist with experience in ACT interventions, supported by a co-facilitating psychologist with experience in psycho-oncology. Group size will be at a maximum of 8 participants per group. The sessions will involve psycho-education, group discussion and group activities (e.g. mindfulness). Adherence will be through attendance logs, text message reminders that participants reply to, and observation by co-facilitators.

The intervention will be based off an ACT protocol used by Feros, Lane, Ciarrochi, and Blackledge (2013) developed by recognised trainers in ACT. This protocol contains a therapist manual and a client manual that provides structure in the form of four modules targeting ACT processes: increasing effective action orientation, mindfulness, self as context, and formal value clarification and commitment. These are divided into four modules: Module 1 – Letting go of unhelpful struggles and making room for living; Module 2 – How we get stuck in our minds and lose sight of our lives as it’s happening now; Module 3 – You are more than your pain, you are more than your suffering, you are more than your cancer; and Module 4 – Moving towards a vital, meaningful life with your pain. Each module contains activities based around metaphors and participants are encouraged to write their responses to session activities and homework readings in their workbook. As there is an emphasis on the protocol on process rather than content, each activity can be modified based on group understanding and ability in order to target the process. The manual outlines 9 x 60-minute individual sessions. In a previous unpublished pilot study, this manual was adapted for a 6-week, 90-minute group therapy format.
Intervention code [1] 316102 0
Behaviour
Intervention code [2] 316103 0
Lifestyle
Comparator / control treatment
Treatment as usual, which is defined as any treatment a patient has chosen to engage in to manage her well being following breast cancer treatment.
Control group
Active

Outcomes
Primary outcome [1] 322000 0
Quality of life as measured by the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Timepoint [1] 322000 0
Pre-intervention (post randomisation), post intervention (primary timepoint), 3 months post intervention
Secondary outcome [1] 376968 0
Experiential avoidance as measured by the Acceptance and Action Questionnaire (AAQ-II)
Timepoint [1] 376968 0
Pre-intervention (post randomisation), post intervention, 3 months post intervention

Eligibility
Key inclusion criteria
Women
Within 2 years post primary breast cancer intervention (e.g. surgery, chemotherapy, radiation therapy)
Early stage breast cancer (Stage 1 - 3)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Highly dependent on medical care
Have psychiatric or neurological disorder that would impair functioning in group situations
Unable to read English or understand spoken English

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)
Central randomisation by computer
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)
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
The sample size was calculated based on the effect size of similar interventions and our pilot study. These studies estimate small and medium effects for the measures used. It is anticipated that analyses will consist of between-within groups ANOVAs with 4 measurement points. In order to have a power of .80 to detect a medium effect, it is estimated that a minimum sample of 24 will be required.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
7/12/2020
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15178 0
Hervey Bay Hospital - Pialba
Recruitment postcode(s) [1] 28484 0
4655 - Pialba
Recruitment postcode(s) [2] 28485 0
4650 - Maryborough
Recruitment postcode(s) [3] 28486 0
4659 - Howard
Recruitment postcode(s) [4] 28487 0
4660 - Childers
Recruitment postcode(s) [5] 28488 0
4662 - Torbanlea

Funding & Sponsors
Funding source category [1] 304303 0
University
Name [1] 304303 0
University of Southern Queensland
Country [1] 304303 0
Australia
Primary sponsor type
Individual
Name
May Chi
Address
Made it Clinic
Shop 1
12 Nissen St
Pialba
QLD 4655
Country
Australia
Secondary sponsor category [1] 304549 0
University
Name [1] 304549 0
University of Southern Queensland
Address [1] 304549 0
University of Southern Queensland
West St
Darling Heights
QLD, 4350
Country [1] 304549 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304757 0
Central Queensland Hospital and Health Service - Central Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 304757 0
Ethics committee country [1] 304757 0
Australia
Date submitted for ethics approval [1] 304757 0
26/11/2019
Approval date [1] 304757 0
Ethics approval number [1] 304757 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98106 0
Ms May Chi
Address 98106 0
Made it Clinic
Shop 1
12 Nissen St
Pialba
QLD 4655
Country 98106 0
Australia
Phone 98106 0
+61 400533952
Fax 98106 0
Email 98106 0
[email protected]
Contact person for public queries
Name 98107 0
May Chi
Address 98107 0
Made it Clinic
Shop 1
12 Nissen St
Pialba
QLD 4655
Country 98107 0
Australia
Phone 98107 0
+61 400533952
Fax 98107 0
Email 98107 0
[email protected]
Contact person for scientific queries
Name 98108 0
May Chi
Address 98108 0
Made it Clinic
Shop 1
12 Nissen St
Pialba
QLD 4655
Country 98108 0
Australia
Phone 98108 0
+61 400533952
Fax 98108 0
Email 98108 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
There may be identifying information in the IPD that would impact on the participant's privacy.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5739Study protocol  [email protected]
5740Ethical approval  [email protected]



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.