Breast Cancer FemaleNCT05327153
The Psychology Intervention on Disease Acceptance and Quality of Life in Breast Cancer Patients
A study testing Acceptance and Commitment Therapy in people with Breast Cancer Female, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The psychological rehabilitation of breast cancer patients plays an important role in the whole process of disease rehabilitation. In this paper, patients with breast cancer were treated with ACT group intervention for a period of four weeks to improve their disease acceptance and psychological flexibility, so as to… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Oct 2022to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients must be 18 years old and above
- early stage of breast cancer (stages 1 to 3)
- newly diagnosed breast cancer patients in the treatment phase
- know about the illness (before and after surgery)
- have basic writing, reading, and verbal communication skills
- volunteer to participate in this study
Who cannot join
- breast cancer patients with more than 65 years old
- patients with metastatic or recurrent breast cancer or other malignant tumors
- patients had participated ACT intervention before
- patients who were diagnosed with psychoses, substances abuser
- people who previously exposed to chemotherapy.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Advanced Medical and Dental Institute Universiti Sains Malaysia
Kepala Batas, Pulau Pinang, 10400
wenjun Song, phd, 0136794518, wenjun@student.usm.my
About this study
Official title: The Efficacy of Acceptance and Commitment Therapy (ACT) on Disease Acceptance and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial
The psychological rehabilitation of breast cancer patients plays an important role in the whole process of disease rehabilitation. In this paper, patients with breast cancer were treated with ACT group intervention for a period of four weeks to improve their disease acceptance and psychological flexibility, so as to improve their quality of life. Finally, its effect and mechanism are explored by covariance analysis and mediation analysis. The significant findings of this study will provide the quality of life changes in breast cancer patients and how did these changes happen and the moderating role of social support in the process of intervention.
Read the detailed description
This is a randomized controlled trial that examines the efficacy of brief acceptance and commitment therapy by comparing the differences between ACT intervention (cases) and waitlist (control). The inclusion criteria are breast cancer patients must be 18 years old and above, early stage of breast cancer (stages 1 to 3), newly diagnosed breast cancer patients in the treatment phase and know about the illness (before and after surgery), have basic writing, reading, and verbal communication skills and volunteer to participate in this study. The exclusion criteria including patients with metastatic or recurrent breast cancer or other malignant tumors, patients had participated ACT intervention before, patients who were diagnosed with psychoses, substances abuser and people who previously exposed to chemotherapy. Respondents will be randomly recruited based on odd and even sequences. Those who are in odd sequence will be assigned into group A, and those who are in even sequence will be assigned into group B. It is stipulated that group A is the intervention group and group B is the control group. The respondents will not know in which group that they belong to ensure the single blinding process. Breast cancer patients from Breast Clinic, IPPT who met the inclusion criteria will be approached andinformed about the study and procedure will be given. Once the respondent agrees to participate, informed consent will be obtained.
- Conditions
- Breast Cancer Female
- Being tested
- Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
The theoretical foundation of ACT is Relational Frame Theory (RFT) based on the functional contextualism philosophy, which suggests that the main psychological problem derived verbal and cognitive interaction with environment, leading to behaviors contrary to long-term values and psychological inflexibility. The psychopathological model of ACT includes six core parts: experiential avoidance, cognitive fusion, attachment to the conceptualized self, conceptualized past and feared future, lack of value clarity, inaction.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Breast cancer patients from the IPPT Breast Clinic who meet the inclusion criteria will be contacted and informed about the study and procedure. Informed consent will be obtained once the respondent agrees to participate. In the case of group psychological intervention, 8 breast cancer patients form one group, and group psychological intervention is given once a week for four weeks as part of the treatment process. The batteries of assessment were carried out at 3-time points; pre-intervention, post-intervention, and 3 months after the intervention. Receives: Behavioral: Acceptance and Commitment Therapy |
| waitlist group | Other | After the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients
The hypothesis is that Acceptance and Commitment Therapy helps improve disease acceptance and quality of life in breast cancer patients. The study collected data through questionnaires. ANCOVA will be employed to examine the significant differences of measured variables between waitlist and intervention groups whilst controlling the covariates.
Measured: 10 months
Secondary outcomes (1)
The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients
The hypotheses is Acceptance and Commitment Therapy intervention can reduce the level of anxiety and depression and improve the quality of life by improving psychological flexibility and disease cognition. Meanwhile, As a way of social support, ACT intervention can moderator disease acceptance and quality of life. The study collected data through the corresponding questionnaires. Mediation analysis and moderation analysis will be computed via PROCESS macro Version 3.5 by Andrew F. Hayes.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Oct 2022
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Wenjun, Universiti Sains Malaysia
- Investigators
- En.Mohd Bazlan Hafidz Mukrim, phd, Principal investigator, Setiausaha Jawatankuasa Etika Penyelidikan USM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327153
- Sponsor's protocol ID
- 20220303swj0211
- Status last verified
- May 2023
- First submitted
- 3 Mar 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song W, Shari NI, Abdullah MFILB, Hussin HB, Zhang R, Mansor NS. Acceptance and commitment therapy improves the quality of life of breast cancer patients by reducing helplessness: a randomized controlled trial. BMC Palliat Care. 2026 Mar 5;25(1):67. doi: 10.1186/s12904-026-02049-5.
PubMed 41787365Song W, Shari NI, Song J, Zhang R, Mansor NS, Leong Bin Abdullah MFI, Zhang Z. Effectiveness of Acceptance and Commitment Therapy (ACT) on disease acceptance for breast cancer patients: Study protocol of a randomized controlled trial. PLoS One. 2024 Nov 11;19(11):e0312669. doi: 10.1371/journal.pone.0312669. eCollection 2024.
PubMed 39527516
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acceptance and Commitment Therapy (ACT) on Disease Acceptance and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05327153
- Acronym / sponsor ID
- 20220303swj0211
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The psychological rehabilitation of breast cancer patients plays an important role in the whole process of disease rehabilitation. In this paper, patients with breast cancer were treated with ACT group intervention for a period of four weeks to improve their disease acceptance and psychological flexibility, so as to improve their quality of life. Finally, its effect and mechanism are explored by covariance analysis and mediation analysis. The significant findings of this study will provide the quality of life changes in breast cancer patients and how did these changes happen and the moderating role of social support in the process of intervention.
Detailed description
This is a randomized controlled trial that examines the efficacy of brief acceptance and commitment therapy by comparing the differences between ACT intervention (cases) and waitlist (control). The inclusion criteria are breast cancer patients must be 18 years old and above, early stage of breast cancer (stages 1 to 3), newly diagnosed breast cancer patients in the treatment phase and know about the illness (before and after surgery), have basic writing, reading, and verbal communication skills and volunteer to participate in this study. The exclusion criteria including patients with metastatic or recurrent breast cancer or other malignant tumors, patients had participated ACT intervention before, patients who were diagnosed with psychoses, substances abuser and people who previously exposed to chemotherapy. Respondents will be randomly recruited based on odd and even sequences. Those who are in odd sequence will be assigned into group A, and those who are in even sequence will be assigned into group B. It is stipulated that group A is the intervention group and group B is the control group. The respondents will not know in which group that they belong to ensure the single blinding process. Breast cancer patients from Breast Clinic, IPPT who met the inclusion criteria will be approached andinformed about the study and procedure will be given. Once the respondent agrees to participate, informed consent will be obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Acceptance and Commitment TherapyBreast cancer patients from the IPPT Breast Clinic who meet the inclusion criteria will be contacted and informed about the study and procedure. Informed consent will be obtained once the respondent agrees to participate. In the case of group psychological intervention, 8 breast cancer patients form one group, and group psychological intervention is given once a week for four weeks as part of the treatment process. The batteries of assessment were carried out at 3-time points; pre-intervention, post-intervention, and 3 months after the intervention. |
| waitlist group | Other | Behavioral: Acceptance and Commitment TherapyAfter the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- breast cancer patients must be 18 years old and above
- early stage of breast cancer (stages 1 to 3)
- newly diagnosed breast cancer patients in the treatment phase
- know about the illness (before and after surgery)
- have basic writing, reading, and verbal communication skills
Key exclusion criteria (5 listed)
- breast cancer patients with more than 65 years old
- patients with metastatic or recurrent breast cancer or other malignant tumors
- patients had participated ACT intervention before
- patients who were diagnosed with psychoses, substances abuser
- people who previously exposed to chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyThe theoretical foundation of ACT is Relational Frame Theory (RFT) based on the functional contextualism philosophy, which suggests that the main psychological problem derived verbal and cognitive interaction with environment, leading to behaviors contrary to long-term values and psychological inflexibility. The psychopathological model of ACT includes six core parts: experiential avoidance, cognitive fusion, attachment to the conceptualized self, conceptualized past and feared future, lack of value clarity, inaction. | Behavioural | intervention group, waitlist group |
Primary outcome
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients
Time frame: 10 months
The hypothesis is that Acceptance and Commitment Therapy helps improve disease acceptance and quality of life in breast cancer patients. The study collected data through questionnaires. ANCOVA will be employed to examine the significant differences of measured variables between waitlist and intervention groups whilst controlling the covariates.
1 secondary outcome
The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 41787365Song W, Shari NI, Abdullah MFILB, Hussin HB, Zhang R, Mansor NS. Acceptance and commitment therapy improves the quality of life of breast cancer patients by reducing helplessness: a randomized controlled trial. BMC Palliat Care. 2026 Mar 5;25(1):67. doi: 10.1186/s12904-026-02049-5.
- Derived from this study: PubMed 39527516Song W, Shari NI, Song J, Zhang R, Mansor NS, Leong Bin Abdullah MFI, Zhang Z. Effectiveness of Acceptance and Commitment Therapy (ACT) on disease acceptance for breast cancer patients: Study protocol of a randomized controlled trial. PLoS One. 2024 Nov 11;19(11):e0312669. doi: 10.1371/journal.pone.0312669. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
En.Mohd Bazlan Hafidz Mukrim, phd principal investigator
Setiausaha Jawatankuasa Etika Penyelidikan USM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Breast Cancer Female, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenjun song, phd (0136794518, wenjun@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.