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Trial registered on ANZCTR


Registration number
ACTRN12617001322325
Ethics application status
Approved
Date submitted
8/09/2017
Date registered
14/09/2017
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a group-based Acceptance and Commitment Therapy (ACT) intervention on quality of life following treatment for early breast cancer
Scientific title
Effectiveness of a group-based Acceptance and Commitment Therapy (ACT) intervention on quality of life following treatment for early breast cancer: a randomised controlled trial
Secondary ID [1] 292827 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-specific distress 304661 0
Psychological distress 304662 0
Quality of life 304663 0
Condition category
Condition code
Cancer 303980 303980 0 0
Breast
Mental Health 303981 303981 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomly assigned in the Acceptance and Commitment Therapy (ACT) intervention condition will receive a 6-week, 90 minute, weekly group-based face to face program delivered by two psychologists trained in ACT and using the same guidelines detailing the administration of ACT in individual interventions and adaptation of ACT for group interventions. For this study, both psychologists will use the same set of guidelines detailing adaption of ACT activities and schedule for a group-based ACT intervention. The ACT intervention program focuses on providing participants with strategies based on the six core processes of ACT(Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing their psychological flexibility and wellbeing through improving management of distress, mood and quality of life.

Participation will also involve completing an ACT workbook and practicing ACT outside group sessions. Each participant will be provided with a printed ACT workbook. During each sessions they will be invited to complete relevant session items in their workbooks. At the end of each session, they will be encouraged to complete home-based activities and practice ACT individually before the next session. After 6 weeks in the ACT intervention program, participants will cross-over to a ‘usual care’ control program.

Intervention adherence will be assessed, at the end of the study, by examining participant engagement with the ACT program as measured through auditing ACT workbooks and a thematic analysis of journal entries.

The study will take place at St Andrew’s Hospital (Toowoomba, Queensland), where both intervention and control programs will be delivered in separate identical non-adjoining meeting rooms.
Intervention code [1] 299075 0
Treatment: Other
Intervention code [2] 299076 0
Behaviour
Comparator / control treatment
There will be two control groups. Participants randomly assigned in the control groups will either: (a) first receive standard care which includes a 6-week 60 minute, weekly group-based face to face breast cancer education (BCE) control program facilitated by a trained breast care nurse and delivered by experts who will provide education presentations and accompanying slides, relating to the following 6 topics: diet, physical activity, sexuality concerns, cancer biology, relaxation techniques and sleep hygiene; or (b) first be in a wait-listed group receiving no BCE or ACT program for 6 weeks.

After 6 weeks, participants in each control group will cross-over to receive the ACT intervention program. Therefore, the three study conditions are:
- Group A: Receiving the ACT intervention program, then crossing over to the BCE control program;
- Group B: Receiving the BCE control program, then crossing over to ACT;
- Group W: Wait-listed, then crossing over to ACT

Given that educational and behavioural interventions are expected to produce effects that last beyond the administration of the intervention, a wash-out period does not apply as participants will be unable to unlearn the strategies presented during the therapy.
Control group
Active

Outcomes
Primary outcome [1] 303315 0
Psychological flexibility will be assessed using the validated Acceptance and Action Questionnaire 2 (AAQ-2).
Timepoint [1] 303315 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.
Primary outcome [2] 303316 0
Physiological stress will be assessed by: (1) changes to measures of blood pressure and resting heart rate (blood pressure will be measured using a stethoscope, blood pressure cuff and aneloid sphygmomanometer and heart rate will be measured using a digital pulse oximeter); and (2) changes in biomarkers collected from blood and saliva samples assayed to determine the impact of self-reported wellbeing on molecular biomarkers such as stress and inflammatory biomarkers and chromosome stability (measured as relative telomere length in buccal cells and leukocytes, plasma tumour necrosis factor, interleukins and c-reactive protein, salivary amylase and cortisol (plasma and salivary)).
Timepoint [2] 303316 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.
Secondary outcome [1] 338614 0
Quality of life (QoL) will be assessed using the Functional Assessment of Cancer Therapy – Breast (FACT-B).
Timepoint [1] 338614 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.
Secondary outcome [2] 338615 0
Fear of cancer recurrence will be assessed using the Concerns About Reoccurrence Scale (CARS).
Timepoint [2] 338615 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.
Secondary outcome [3] 338735 0
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS).
Timepoint [3] 338735 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.
Secondary outcome [4] 338736 0
Participant engagement with the ACT program will be assessed through auditing ACT workbooks and a thematic analysis of journal entries.
Timepoint [4] 338736 0
Pre-intervention (at baseline): Week1, immediately before start of each study condition (i.e., for Group A, Group B, Group W).
Post-intervention: Upon completion of each study condition, before cross-over.
Follow-up: 6 months and 12 months after the final study session.

Eligibility
Key inclusion criteria
Eligible study participants will include women aged 18 years or older who have completed primary treatment (surgery, neoadjuvant or adjuvant chemotherapy and radiation therapy) for early (stage 1 - 3) breast cancer in the previous two years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded for any of the following reasons:
(1) currently undergoing treatment with a psychiatrist or mental health therapist (however prior therapy does not disqualify from eligibility to participate in this research provided it occurred more than two years before the start of the study);
(2) highly dependent on medical care;
(3) having a history of or prior mood disorder diagnosed before cancer diagnosis;
(4) psychiatric or neurological disorders;
(5) unable to read or understand spoken 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)
Random allocation will be concealed to project team members who will determine whether a participant is eligible for inclusion in the trial. Randomisation will be performed by a project team member not involved in eligibility screening and blinded to the identity of eligible participants,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated permuted block randomisation via http://www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Pilot study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/09/2017
Actual
16/09/2017
Date of last participant enrolment
Anticipated
Actual
16/09/2017
Date of last data collection
Anticipated
Actual
2/12/2017
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297457 0
Charities/Societies/Foundations
Name [1] 297457 0
Blush Cancer Care
Country [1] 297457 0
Australia
Funding source category [2] 297458 0
University
Name [2] 297458 0
University of Southern Queensland
Country [2] 297458 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
Mail Room West Street, Toowoomba, 4350, QLD
Country
Australia
Secondary sponsor category [1] 296454 0
None
Name [1] 296454 0
Address [1] 296454 0
Country [1] 296454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298563 0
Darling Downs Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 298563 0
Pechey Street, Toowoomba, Queensland 4350
Ethics committee country [1] 298563 0
Australia
Date submitted for ethics approval [1] 298563 0
25/05/2017
Approval date [1] 298563 0
22/08/2017
Ethics approval number [1] 298563 0
HREC/17/QTDD/51
Ethics committee name [2] 298565 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [2] 298565 0
Mail Room West Street, Toowoomba, 4350, QLD
Ethics committee country [2] 298565 0
Australia
Date submitted for ethics approval [2] 298565 0
Approval date [2] 298565 0
28/08/2017
Ethics approval number [2] 298565 0
USQ HREC H17REA184

Summary
Brief summary
This study will investigate the effectiveness of group-based Acceptance and Commitment Therapy (ACT) intervention in improving quality of life following treatment for early breast cancer.

Who is it for?
You may be eligible to join this study if you are a woman aged 18 years or above and have completed primary treatment for early breast cancer within the last two years.

What does this study involve?
In this study, all participants will receive the ACT intervention condition in random order. Participant will be randomly allocated to one of the following combination of study conditions: 1) Group A will first receive the ACT intervention program, then receive a breast cancer education (BCE) control program; 2) Group B will first receive the BCE control program, then cross-over to receive the ACT intervention program; or 3) Group W will first be on a 6-week wait-list during which participants receive neither programs, then they will receive the ACT intervention. As each study condition will be conducted weekly and will run for a 6-week period, with no allocated time interruption in between each condition, study duration is expected to be 12 weeks. In addition to attending group sessions, participation will also involve completing an ACT workbook. The workbook will guide participants through regular individual ACT practice outside group sessions.

The ACT program will be delivered by an ACT-trained psychologist and will focus on providing participants with strategies based on the six core processes of ACT (Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing participants' psychological flexibility and wellbeing. The BCE program will be facilitated by a trained breast care nurse and delivered by experts who will provide education relating to diet, physical activity, sexuality concerns, cancer biology, clinical physiology, relaxation techniques and sleep hygiene.

At the beginning and end of each 6-week study condition period, questionnaires will be administered, blood and saliva samples will be collected, and blood pressure and resting heart rate will be measured. Participants will be followed-up at 6 and 12 months after the final session.

Benefits of this study?
Participating in this research has the potential to improve the quality of life of project participants and help them better manage anxieties related to fear of cancer recurrence.

This study has been approved by the Human Research Ethics Committees of the Darling Downs Hospital and Health Services (DDHHS) and the University of Southern Queensland (USQ).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77482 0
Dr Eliza Whiteside
Address 77482 0
University of Southern Queensland, Mail Room West Street, Toowoomba, 4350, QLD
Country 77482 0
Australia
Phone 77482 0
+61 7 4631 2785
Fax 77482 0
Email 77482 0
eliza.whiteside@usq.edu.au
Contact person for public queries
Name 77483 0
Dr Eliza Whiteside
Address 77483 0
University of Southern Queensland, Mail Room West Street, Toowoomba, 4350, QLD
Country 77483 0
Australia
Phone 77483 0
+61 7 4631 2785
Fax 77483 0
Email 77483 0
eliza.whiteside@usq.edu.au
Contact person for scientific queries
Name 77484 0
Dr Eliza Whiteside
Address 77484 0
University of Southern Queensland, Mail Room West Street, Toowoomba, 4350, QLD
Country 77484 0
Australia
Phone 77484 0
+61 7 4631 2785
Fax 77484 0
Email 77484 0
Eliza.Whiteside@usq.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.