Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607714756174 Date of Registration: 22/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of a Group-Based Acceptance and Commitment Therapy (ACT) Intervention on Anxiety and Depression Among Breast Cancer Survivors: A Randomized Clinical Trial
Official scientific title The Effects of a Group-Based Acceptance and Commitment Therapy (ACT) Intervention on Anxiety and Depression Among Breast Cancer Survivors: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The Global Cancer Observatory reported approximately 20 million new cancer cases and 9.7 million deaths in 2022, with breast cancer representing the most frequently diagnosed cancer among women worldwide. It accounted for an estimated 2.3 million new cases and 670,000 deaths globally. In sub-Saharan Africa, including Ethiopia, breast cancer mortality remains disproportionately high, with nearly 80% of cases diagnosed at advanced stages. In response, ongoing efforts have focused on strengthening cancer care systems through improved access to treatment services, enhanced public awareness, and early detection strategies. However, despite these initiatives, most oncology services focus on treatment procedures addressing patients’ physical signs and symptoms, with limited attention to the psychological burden experienced by breast cancer survivors. Breast cancer significantly affects psychological well-being in addition to physical health, with many patients experiencing high levels of depressive and anxiety symptoms. These challenges are often exacerbated by inadequate mental health support within oncology care systems. Evidence suggests that approximately 50% of breast cancer survivors worldwide experience depressive and anxiety symptoms, with even higher prevalence reported in African settings. Persistent depressive and anxiety symptoms can compromise patients’ coping ability, negatively influencing treatment adherence, quality of life, disease prognosis, and overall health outcomes. Therefore, addressing the psychological needs of breast cancer survivors is essential for comprehensive and holistic cancer care. Acceptance and Commitment Therapy (ACT) is a psychological intervention designed to enhance psychological flexibility and support individuals in managing distressing thoughts and emotions more effectively. In this context, this randomized clinical trial aims to evaluate the effectiveness of a group-based ACT intervention in reducing depressive and anxiety symptoms among Ethiopian breast cancer survivors compared with usual care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/08/2026
Actual trial start date 04/09/2026
Anticipated date of last follow up 14/07/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 550
Actual target sample size (number of participants) 112
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care group Participants in the control group will continue to receive usual care The intervention will be delivered over 6 weeks. Participants in the usual care group will continue to receive standard oncology care provided at the study hospital, which may include routine medical follow-up, pharmacological treatment, symptom management, and general counseling as available. No structured psychological intervention will be provided as part of the study. 56 Historical
Experimental Group Group Based Acceptance and Commitment Therapy Weekly group-based ACT sessions (once per week) delivered over 6 weeks The intervention will be delivered over a period of 6 weeks. Session 1 introduces participants to the ACT model, emphasizing psychological flexibility as the ability to remain present, open, and engaged in value-based actions despite emotional distress. Psychoeducation is provided on depressive and anxiety symptoms in the context of breast cancer, followed by an introduction to mindfulness exercises, including breathing techniques aimed at promoting relaxation and reducing stress. Session 2 focuses on understanding human suffering and experiential avoidance, helping participants recognize how attempts to control or suppress painful thoughts and emotions may increase depressive and anxiety symptoms. A supportive group environment is used to encourage open discussion and normalization of emotional responses to cancer. Session 3 targets cognitive fusion and internalized stigma through acceptance and cognitive defusion techniques, helping participants observe thoughts as transient mental events rather than literal truths. Session 4 introduces the concept of self-as-context, enabling participants to develop a stable sense of self beyond illness, thoughts, and emotions, supported by mindfulness exercises that promote self-awareness and compassion. Session 5 focuses on values clarification, guiding participants to identify what is most meaningful in areas such as relationships, health, family, and spirituality, and to reconnect with purpose during illness. Session 6 emphasizes committed action, where participants develop individualized, SMART-based action plans aligned with their values, identify barriers, and apply ACT strategies to overcome them. The session concludes with group reflection, mindfulness practice, and development of a personal plan for continued value-based living and psychological well-being. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed histological diagnosis of breast cancer (any stage) Age 18 years and above Currently undergoing or having completed active cancer treatment (surgery, chemotherapy, radiotherapy, or hormonal therapy) within the past five years Ability to provide informed consent Score of 8 or higher on at least one subscale of the Hospital Anxiety and Depression Scale (HADS) Unable to listen to or speak Amharic Currently receiving or having received another form of psychological therapy Severe cognitive impairment or active psychosis that prevents questionnaire completion Pre-existing major psychiatric disorder diagnosed prior to cancer diagnosis Critically ill condition 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/05/2025 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
No. 44 Wenhua Xi Road Jinan 250012 China
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/07/2025 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Swaziland St. Addis Ababa Addis Ababa 1000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anxiety and depression symptoms Baseline, post-intervention, and 5 month followup after the intervention
Secondary Outcome Psychological flexibility Baseline, post-intervention, and 5 month followup after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Saint Pauls Hospital Millennium Medical College Swaziland Street Addis Ababa 1271 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Shandong University 27 Shanda Nanlu, Licheng District, Jinan, Shandong, P.R. China 250100 Jinan 250100 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shandong University 27 Shanda Nanlu, Licheng District, Jinan, Shandong, P.R. China 250100 Jinan 250100 China University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fitsum Molla Chanie fitsum.molla@sphmmc.edu.et +251933344947 Swaziland Street
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Feng Danjun Fdj19@sdu.edu.cn 053188382695 44 West Wenhua Road, Jinan, Shandong, China
City Postal code Country Position/Affiliation
Jinan 250012 China Professor
Role Name Email Phone Street address
Public Enquiries Wenwen Kong hw33269@163.com +8615554196650 No. 44 Wenhua Xi Road, Lixia District, Jinan, Shandong, China
City Postal code Country Position/Affiliation
Jinan 250012 China PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in publications arising from this study, after de-identification, including outcome measures, demographic variables, and relevant study data presented in text, tables, figures, and appendices. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The de-identified individual participant data will be available within 12 months after study completion Data will be available upon reasonable request to the principal investigator, subject to ethical approval and confidentiality requirements
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/07/2026 Uploaded the ethics approval letter from the country where participant recruitment will be conducted, as requested by the PACTR reviewers. TRUE, Institutional Review Board, Swaziland St. Addis Ababa, Addis Ababa, 1000, Ethiopia, , 01 Jul 2025, +251112750125, info@sphmmc.edu.et, 41406_40034_4737.pdf