Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000542594p
Ethics application status
Submitted, not yet approved
Date submitted
7/03/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of acceptance and commitment therapy (ACT) on psychological flexibility and psychological well-being among breast cancer patients with chronic pain
Scientific title
The feasibility of acceptance and commitment therapy (ACT) on psychological flexibility and psychological well-being among breast cancer patients with chronic pain
Secondary ID [1] 311694 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 333160 0
Chronic pain 333161 0
Condition category
Condition code
Cancer 329855 329855 0 0
Breast
Mental Health 330116 330116 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. A total of 8 group sessions (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. Sessions will be conducted once per week for 8 weeks. Participants will need to answer several questions which include: List of demographic information and feasibility of the program which anticipated to take 2 minutes to complete; visual analogue scale which anticipated to take 1 minute to complete; suggestion and patients experience which anticipated to take 5 minutes to complete
Intervention code [1] 328158 0
Treatment: Other
Intervention code [2] 328341 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337628 0
Patient attitude towards utility of ACT
Timepoint [1] 337628 0
the interview question was proposed face-to-face at the end of the final ACT session (i.e. at the end of the 8 week program).
Secondary outcome [1] 432581 0
Severity of pain
Timepoint [1] 432581 0
the interview question was proposed face-to-face at the end of the final ACT session (i.e. at the end of the 8 week program).

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (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
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 26192 0
Malaysia
State/province [1] 26192 0

Funding & Sponsors
Funding source category [1] 316023 0
University
Name [1] 316023 0
University of Cyberjaya
Country [1] 316023 0
Malaysia
Primary sponsor type
University
Name
University of Cyberjaya
Address
Country
Malaysia
Secondary sponsor category [1] 318176 0
None
Name [1] 318176 0
Address [1] 318176 0
Country [1] 318176 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314846 0
National Medical Research Register
Ethics committee address [1] 314846 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] 314846 0
Malaysia
Date submitted for ethics approval [1] 314846 0
29/02/2024
Approval date [1] 314846 0
Ethics approval number [1] 314846 0
RSCH ID-23-05784-C0J
Ethics committee name [2] 314847 0
University Kuala Lumpur Campus
Ethics committee address [2] 314847 0
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpu
Ethics committee country [2] 314847 0
Malaysia
Date submitted for ethics approval [2] 314847 0
29/02/2024
Approval date [2] 314847 0
Ethics approval number [2] 314847 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 the feasibility of 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, with a pilot involving ten patients Participants will be recruited based on purposive sampling method. The goal of the study is to assess the feasibility of the intervention, 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 132910 0
Miss Lim Jia Hang
Address 132910 0
Malaysia National University Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 132910 0
Malaysia
Phone 132910 0
+60102937510
Fax 132910 0
Email 132910 0
p121861@siswa.ukm.edu.my
Contact person for public queries
Name 132911 0
Lim Jia Hang
Address 132911 0
Malaysia National University Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 132911 0
Malaysia
Phone 132911 0
+60102937510
Fax 132911 0
Email 132911 0
p121861@siswa.ukm.edu.my
Contact person for scientific queries
Name 132912 0
Lim Jia Hang
Address 132912 0
Malaysia National University Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 132912 0
Malaysia
Phone 132912 0
+60102937510
Fax 132912 0
Email 132912 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.