The Psychology Intervention on Disease Acceptance and Quality of Life in Breast Cancer Patients

NCT ID: NCT05327153

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-11-20

Brief 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 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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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.

waitlist group

After the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group.

Group Type: OTHER

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Acceptance and Commitment Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Song Wenjun

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

En.Mohd Bazlan Hafidz Mukrim, phd

Role: PRINCIPAL_INVESTIGATOR

Setiausaha Jawatankuasa Etika Penyelidikan USM

Locations

Advanced Medical and Dental Institute Universiti Sains Malaysia

Kepala Batas, Pulau Pinang, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

wenjun song, phd

Role: CONTACT

wenjun@student.usm.my

0136794518

Nor shuhada Murad, phd

Role: CONTACT

shuhada.mansor@usm.my

0135866300

Facility Contacts

wenjun Song, phd

Role: primary

wenjun@student.usm.my

0136794518

References

Song 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.

Reference Type: DERIVED

PMID: 39527516 (View on PubMed)

Other Identifiers

20220303swj0211

Identifier Type: -

Identifier Source: org_study_id