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

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Advanced Medical and Dental Institute Universiti Sains MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

intervention group

waitlist group

Arm Description

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.

After the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 3, 2022
Last Updated
May 9, 2023
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05327153
Brief Title
The Psychology Intervention on Disease Acceptance and Quality of Life in Breast Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
November 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
waitlist group
Arm Type
Other
Arm Description
After the intervention of the intervention group, the waitlist group was interfered again. The batteries of assessment was same as the intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients
Description
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.
Time Frame
1 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wenjun song, phd
Phone
0136794518
Email
wenjun@student.usm.my
First Name & Middle Initial & Last Name or Official Title & Degree
Nor shuhada Murad, phd
Phone
0135866300
Email
shuhada.mansor@usm.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En.Mohd Bazlan Hafidz Mukrim, phd
Organizational Affiliation
Setiausaha Jawatankuasa Etika Penyelidikan USM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Medical and Dental Institute Universiti Sains Malaysia
City
Kepala Batas
State/Province
Pulau Pinang
ZIP/Postal Code
10400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenjun Song, phd
Phone
0136794518
Email
wenjun@student.usm.my

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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