Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000512527p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2024
Date registered
25/04/2024
Date last updated
25/04/2024
Date data sharing statement initially provided
25/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of acceptance and commitment therapy (ACT) on psychological flexibility and psychological well-being among breast cancer patients with chronic pain
Scientific title
The Efficacy of Acceptance and commitment therapy (ACT) on psychological flexibility and psychological well-being among breast cancer patients with chronic pain
Secondary ID [1] 311348 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 332608 0
Chronic Pain 333158 0
Condition category
Condition code
Cancer 329310 329310 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a. Acceptance and Commitment Therapy (ACT) ACT is a psychotherapy that focuses on enhances psychological flexibility by facilitating acceptance of unpleasant private events and an increase in valued actions, rather than attempting to develop control over unpleasant private events. It consists of six central processes (acceptance, cognitive diffusion, contact with the present moment, self-as-context, values, and committed action) that lead to psychological flexibility. The primary aim of ACT is to improve the functioning status of breast patients with chronic pain. It can be beneficial by helping them develop skills to cope with their pain more effectively. Through ACT, patients can learn to accept the presence of pain without struggling against it, allowing them to focus instead on engaging in activities that are meaningful and fulfilling to them despite the pain.

b. A total of 8 group session (each 90 minutes) will be conducted by trained psychotherapist with at least three years of experience in ACT. A maximum of 10 participant will be in 1 group The therapy will be conducted at University Kebangsaan Malaysia.

c. Session attendance checklists will be used to monitor adherence to the intervention:
d. The topic of session include;
Session 1: Introduction for the intervention and approach.
Session 2: Extraction of avoidance experience, mixing and individual values.
Session 3: Exploration of life values
Session 4: Identifying goals
Session 5: Cognitive restructuring
Session 6: Action planned
Session 7: Mindfulness
Session 8: Termination
Intervention code [1] 327794 0
Treatment: Other
Comparator / control treatment
For the control group (standard care), the participants will receive the usual or standard treatment for their condition, as determined by the healthcare provider or clinical guidelines. The duration of the comparator treatment will be 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 337626 0
psychological flexibility
Timepoint [1] 337626 0
baseline, 2months after baseline, and 5 months after baseline
Primary outcome [2] 337627 0
Psychological well-being
Timepoint [2] 337627 0
baseline, 2months after baseline, and 5 months after baseline
Secondary outcome [1] 432580 0
Severity of pain
Timepoint [1] 432580 0
baseline, 2months after baseline, and 5 months after baseline

Eligibility
Key inclusion criteria
1. Participants must be able to read and write.
2. Participants diagnose with breast cancer (stage 2/3) or who are at least after 6 months post-diagnosis.
3. Participants who have been experiencing pain for more than 3 months.
4. Participants must be 18 years old and above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals who are formally diagnosed with mental disorders or are under psychotropic medication.
2. Patient unable to give consent, i.e. due to mental or disease issues (metastatic spread to the brain, etc.)

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
19/06/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26085 0
Malaysia
State/province [1] 26085 0

Funding & Sponsors
Funding source category [1] 315604 0
University
Name [1] 315604 0
University of Cyberjaya
Country [1] 315604 0
Malaysia
Primary sponsor type
University
Name
University of Cyberjaya
Address
Persiaran Bestari, Cyber 11, 63000 Cyberjaya, Selangor
Country
Malaysia
Secondary sponsor category [1] 317696 0
None
Name [1] 317696 0
Address [1] 317696 0
Country [1] 317696 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314492 0
National Medical Research Register
Ethics committee address [1] 314492 0
Block A, Kompleks Institut Kesihatan Negara (NIH) No 1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, 40170 Shah Alam
Ethics committee country [1] 314492 0
Malaysia
Date submitted for ethics approval [1] 314492 0
29/02/2024
Approval date [1] 314492 0
Ethics approval number [1] 314492 0
RSCH ID-23-05784-C0J
Ethics committee name [2] 314494 0
University Kuala Lumpur Campus
Ethics committee address [2] 314494 0
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Ethics committee country [2] 314494 0
Malaysia
Date submitted for ethics approval [2] 314494 0
29/02/2024
Approval date [2] 314494 0
Ethics approval number [2] 314494 0

Summary
Brief summary
Aligned with Malaysia's National Strategic Plan for Cancer Control Programme (2021-2025) and the National Palliative Care Policy and Strategic Plan (2019-2030), this research aims to investigate interventions for chronic pain and psychological wellbeing in breast cancer patients. Breast cancer is the leading cancer among women globally and the second leading cause of cancer-related deaths. Statistics show that 25% to 60% of women undergoing breast cancer treatment report pain. Despite biomedical advancements, unresolved issues persist in understanding the biopsychosocial aspects of breast cancer. The study proposes using Acceptance and Commitment Therapy (ACT) as a psychological intervention, A total of forty participants will be randomly assigned to either a treatment group or a control group (standard care). Participants will be recruited based on purposive sampling method. The goal of the study is to assess the effectiveness of the intervention, and a follow-up study will be conducted after 3 months. The intervention's effectiveness will be analyzed using various statistical analysis. It is expected that the research outcomes will facilitate the development of future studies focused on chronic pain, psychological flexibility, and psychological well-being in breast cancer patients with chronic pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131778 0
Miss Lim Jia Hang
Address 131778 0
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 131778 0
Malaysia
Phone 131778 0
+60102937510
Fax 131778 0
Email 131778 0
p121861@siswa.ukm.edu.my
Contact person for public queries
Name 131779 0
Miss Lim Jia Hang
Address 131779 0
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 131779 0
Malaysia
Phone 131779 0
+60102937510
Fax 131779 0
Email 131779 0
p121861@siswa.ukm.edu.my
Contact person for scientific queries
Name 131780 0
Miss Lim Jia Hang
Address 131780 0
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 131780 0
Malaysia
Phone 131780 0
+60102937510
Fax 131780 0
Email 131780 0
p121861@siswa.ukm.edu.my

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.