Clinical trial NCT05327153: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients
timeFrame: 10 months
Secondary outcomes:
measure: The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients
timeFrame: 1 months
Other outcomes:
Locations:
city: Kepala Batas
country: Malaysia
facility: Advanced Medical and Dental Institute Universiti Sains Malaysia
state: Pulau Pinang
Study officials:
affiliation: Setiausaha Jawatankuasa Etika Penyelidikan USM
name: En.Mohd Bazlan Hafidz Mukrim, phd
role: PRINCIPAL_INVESTIGATOR
References: