NCT05327153

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

The Efficacy of Acceptance and Commitment Therapy (ACT) on Disease Acceptance and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-10-20
• Completion: 2024-11-20
• First posted: 2022-04-14
• Last updated: 2023-05-11

Locations

1 site across 1 country: Malaysia