Acceptance and Commitment Therapy for Women with Breast Cancer
Efficacy of a Brief Intervention for Female Breast CANcer Based on Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain: A 2-Arm Randomized Clinical Trial
This study is testing an online therapy program for women with breast cancer to see if it can help reduce their pain and depression while improving their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Cyprus Academic / other |
| Locations | 1 site (Nicosia, Non-US/Non-Canadian) |
| Trial ID | NCT05374161 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on women diagnosed with breast cancer who are experiencing co-occurring psychological and physical symptoms, particularly depression and pain. The I-CAN-ACT project will evaluate the effectiveness of a brief Acceptance and Commitment Therapy (ACT) intervention delivered online over six sessions, comparing outcomes to a waitlist control group. The study aims to assess improvements in quality of life, pain intensity, depression, and anxiety at multiple follow-up points after treatment. Participants will be monitored for changes in their overall well-being and symptom interference.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, fluent in Greek, diagnosed with stages I, II, or III breast cancer, and experiencing mild depression and physical pain.
Not a fit: Patients with stage IV breast cancer, significant cognitive impairment, or a history of severe psychopathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and reduce psychological and physical symptoms in women with breast cancer.
How similar studies have performed: Preliminary findings suggest that ACT has been beneficial in similar contexts, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Understanding and speaking fluently in Greek * Age 18 and older * Education level should be at least elementary school (ability to read and write) * Diagnosed breast cancer in stages I, II or III * Underwent breast surgery * Experiencing at least mild depression and at least mild intensity and interference of physical pain Exclusion Criteria: * A history of metastasis (stage IV cancer) * Significant cognitive impairment assessed using the Mini-mental State Examination (MMSE score \< 20) * A history of severe psychopathology (i.e., psychosis), suicidal ideation, substance use problems before breast cancer
Where this trial is running
Nicosia, Non-US/Non-Canadian
- University of Cyprus — Nicosia, Non-US/Non-Canadian, Cyprus (Recruiting)
Study contacts
- Principal investigator: Maria Karekla, Ph.D. — ACThealthy Lab, University of Cyprus
- Study coordinator: Maria Karekla, Ph.D.
- Email: mkarekla@ucy.ac.cy
- Phone: 0035722892100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.