Clinical trial · Interventional
The Validation of ICBT Clinical Trial: Disease Stress Adjustment in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors | Behavioral | — | UNRESOLVED |
| Treatment as Usual (TAU) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICBT Plus Treatment as Usual
- description
- Participants will continue to receive treatment as usual and will additionally complete the 8-week "Healthy Steps: Women's Mental Well-Being" Internet-based cognitive behavioral therapy program through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. Participants' learning progress, questionnaire completion, and application use will be recorded through the study system.
- interventionNames
- Behavioral: Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors
- type
- ACTIVE_COMPARATOR
- label
- Treatment as Usual Control
- description
- Participants assigned to this arm will receive treatment as usual (TAU), consisting of routine clinical care provided by their treating health care professionals. They will not receive the Internet-based cognitive behavioral therapy program during the main comparative study period and will complete assessments according to the same schedule as the intervention group. After completing all study assessments, participants may request access to the ICBT program.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Access to an Internet-enabled device and ability to independently participate in the online intervention. * Willingness to complete the online intervention modules and study assessment questionnaires. Exclusion Criteria: * 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. * No current psychiatric diagnosis but a Patient Health Questionnaire-9 (PHQ-9) score greater than 20 at screening. * Current suicidal intent or a history of actual self-harm behavior. * Currently receiving another form of psychotherapy or having recently received cognitive behavioral therapy. * Inability to independently use the online intervention application because of insufficient Chinese literacy, Internet proficiency, or access to an Internet-enabled device.
References
Publications (0)
Data not yet available