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

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327153
• Other study ID #: 20220303swj0211
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: November 20, 2024

Study information

• Verified date: May 2023
• Source: Universiti Sains Malaysia
• Contact: wenjun song, phd
• Phone: 0136794518
• Email: wenjun[@]student.usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 20, 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Advanced Medical and Dental Institute Universiti Sains Malaysia	Kepala Batas	Pulau Pinang

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months
Secondary	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.	1 months