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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05327153
Enrollment
90
Registered
2022-04-14
Start date
2022-10-20
Completion date
2024-11-20
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

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.

Interventions

BEHAVIORALAcceptance 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.

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To examine the efficacy of brief acceptance and commitment therapy on disease acceptance and quality of life of breast cancer patients10 monthsThe 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

MeasureTime frameDescription
The mechanism between acceptance and commitment therapy with disease acceptance and quality of life in breast cancer patients1 monthsThe 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.

Countries

Malaysia

Contacts

Primary Contactwenjun song, phd
wenjun@student.usm.my0136794518
Backup ContactNor shuhada Murad, phd
shuhada.mansor@usm.my0135866300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026