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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wenjun Song, phd; Phone Number: 0136794518; Email: wenjun@student.usm.my
• Study Contact Backup: Name: Nor shuhada Murad, phd; Phone Number: 0135866300; Email: shuhada.mansor@usm.my

Study Locations

• Malaysia
  • Pulau Pinang
    • Kepala Batas, Pulau Pinang, Malaysia, 10400
      • Recruiting
      • Advanced Medical and Dental Institute Universiti Sains Malaysia
      • Contact: wenjun Song, phd; Phone Number: 0136794518; Email: wenjun@student.usm.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: En.Mohd Bazlan Hafidz Mukrim, phd, Setiausaha Jawatankuasa Etika Penyelidikan USM

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Anticipated): October 20, 2023
• Study Completion (Anticipated): November 20, 2024

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20220303swj0211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No