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

Universiti Sains Malaysia

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Behavioral: Acceptance and Commitment Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05327153

20220303swj0211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment Therapy

waitlist group

Other group

Description:

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

Treatment:

Behavioral: Acceptance and Commitment Therapy