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

• ClinicalTrials.gov Identifier: NCT05327153
• Recruitment Status: Not yet recruiting
• First Posted: April 14, 2022
• Last Update Posted: April 15, 2022
• Sponsor: Universiti Sains Malaysia
• Information provided by (Responsible Party): Song Wenjun, Universiti Sains Malaysia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Female	Behavioral: Acceptance and Commitment Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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
• Estimated Study Start Date: October 20, 2022
• Estimated Primary Completion Date: October 20, 2023
• Estimated Study Completion Date: October 20, 2024

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients [ Time Frame: 10 months ]
   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.

Secondary Outcome Measures :

1. The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients [ Time Frame: 1 months ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Song Wenjun, doctor, Universiti Sains Malaysia
• ClinicalTrials.gov Identifier: NCT05327153
• Other Study ID Numbers: 20220303swj0211
• First Posted: April 14, 2022
• Last Update Posted: April 15, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases