Breast cancer and its treatment can cause ongoing emotional distress, including anxiety, depressive symptoms, stress-related reactions, and difficulties adjusting to life after treatment. This study evaluates an 8-week Internet-based cognitive behavioral therapy (ICBT) program designed to support psychological adjustment and improve quality of life among adults with stage I-III breast cancer who have completed primary cancer treatment.
Approximately 100 participants will be randomly assigned to either an ICBT group or a control group. Participants in the ICBT group will receive treatment as usual together with the 8-week online program, while participants in the control group will receive treatment as usual alone during the main study period. The study will compare changes in anxiety, depressive symptoms, post-traumatic stress symptoms, and quality of life between the two groups.
Adults aged 18-65 years.
Diagnosis of stage I-III breast cancer.
Completion of primary breast cancer treatment, including surgery, chemotherapy, radiation therapy, and/or targeted therapy. Participants currently receiving endocrine therapy are eligible.
Ability to read and write Chinese and to use a mobile application and the Internet.
Diagnosis of stage IV breast cancer.
Concurrent diagnosis of another type of cancer.
Currently receiving surgery, chemotherapy, radiation therapy, or targeted therapy for breast cancer.
Diagnosis of a psychiatric disorder within the past 6 months, including major depressive disorder, generalized anxiety disorder, or schizophrenia.
Parallel
Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors
BehavioralAn 8-week Internet-based cognitive behavioral therapy program delivered through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, stress management, relaxation, mindfulness, and coping with cancer-related concerns.
Treatment as Usual (TAU)
Other interventionParticipants will continue to receive routine clinical care provided by their treating health care professionals. No additional Internet-based cognitive behavioral therapy will be provided during the main comparative study period.
Change in Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21
Psychological distress will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21), which includes depression, anxiety, and stress subscales. Each item is rated on a 4-point scale from 0 to 3. Higher scores indicate greater levels of psychological distress. Changes in scores will be compared between the ICBT and TAU groups.
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Changes in scores will be compared between the ICBT and TAU groups.
Change in Post-Traumatic Stress Symptoms as Assessed by the Posttraumatic Diagnostic Scale for DSM-5
Post-traumatic stress symptoms will be assessed using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). The scale assesses the severity of post-traumatic stress symptoms and associated distress and functional impairment. Higher scores indicate greater severity of post-traumatic stress symptoms.
Change in Life Satisfaction as Assessed by the Satisfaction With Life Scale
Life satisfaction will be assessed using the 5-item Satisfaction With Life Scale (SWLS). The total score ranges from 5 to 35, with higher scores indicating greater satisfaction with life.
Change in Insomnia Severity as Assessed by the Insomnia Severity Index
Insomnia severity will be assessed using the 7-item Insomnia Severity Index (ISI). The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
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