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

NCT05327153 | Unknown

• 1 other identifier: 20220303swj0211
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients

  1 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

waitlist group

OTHER

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

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

intervention group; waitlist group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Advanced Medical and Dental Institute Universiti Sains Malaysia

Kepala Batas, Pulau Pinang, 10400, Malaysia

RECRUITING

Related Publications (1)

• Song W, Shari NI, Song J, Zhang R, Mansor NS, Leong Bin Abdullah MFI, Zhang Z. Effectiveness of Acceptance and Commitment Therapy (ACT) on disease acceptance for breast cancer patients: Study protocol of a randomized controlled trial. PLoS One. 2024 Nov 11;19(11):e0312669. doi: 10.1371/journal.pone.0312669. eCollection 2024.

  PMID: 39527516 DERIVED

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• En.Mohd Bazlan Hafidz Mukrim, phd

  Setiausaha Jawatankuasa Etika Penyelidikan USM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wenjun song, phd

CONTACT

0136794518; wenjun@student.usm.my

Nor shuhada Murad, phd

CONTACT

0135866300; shuhada.mansor@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 14, 2022
• Study Start: October 20, 2022
• Primary Completion: October 20, 2023
• Study Completion: November 20, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)