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.: PACTR202609789409726 Date of Registration: 10/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Psychological Intervention to Improve Well-Being in People with Acute Myeloid Leukemia
Official scientific title Effectiveness of an Acceptance and Commitment Therapy-Based Intervention on Psychosocial Outcomes in Patients with Acute Myeloid Leukemia
Brief summary describing the background and objectives of the trial Acute myeloid leukemia (AML) is a life-threatening hematological malignancy associated with substantial physical symptoms, treatment-related toxicities, prolonged hospitalization, social isolation, and uncertainty regarding prognosis. These challenges can contribute to psychological distress, including depression, anxiety, and stress, and can negatively affect patients’ quality of life and overall well-being. Acceptance and Commitment Therapy (ACT) is a psychological intervention that aims to enhance psychological flexibility and help individuals manage distressing thoughts and emotions while maintaining behaviors consistent with their personal values. Evidence from studies in cancer populations suggests that ACT may improve psychological well-being, psychological flexibility, and quality of life and reduce psychological distress. The objective of this trial is to evaluate the effectiveness of an ACT-based intervention in improving psychosocial outcomes among patients with AML. Specifically, the trial will assess patients’ levels of depression, anxiety, and stress; quality of life; and psychological flexibility; implement an ACT-based intervention; and evaluate its effect on these psychosocial outcomes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ACT.AML
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 01/09/2026
Actual trial start date
Anticipated date of last follow up 01/09/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants)
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 Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Acceptance and Commitment Therapy one session/week 5 weeks The intervention will consist of a five-session, group-based Acceptance and Commitment Therapy (ACT) program for patients with acute myeloid leukemia (AML). The program will include one psychoeducation session and four ACT sessions, delivered weekly to groups of 8–12 patients, with each session lasting 60–90 minutes. The sessions will use interactive methods such as group discussions, role-play, brainstorming, illustrations, vignettes, and audio-visual materials. The program will focus on understanding and accepting AML, mindfulness and acceptance, cognitive defusion, self-compassion and self-as-context, identifying personal values, and developing committed, value-based actions to promote psychological flexibility, reduce psychological distress, and improve quality of life. 47
Control Group no intervention zero 5 weeks no intervention 47 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18 years and older. Patients with acute myeloid leukemia post induction therapy phase after receiving the first dose of chemotherapy. Patients with communication problems or severe psychiatric conditions. Patients receiving current psychosocial interventions. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
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 29/07/2025 High Institute of Public Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue El-Hadara, Alexandria, Egypt Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome depressive, anxiety, and stress symptoms. 3 times- preintervention- immediately at the end of the intervention and 3 months later
Secondary Outcome quality of life 3 times- preintervention-immediately at the end of the intervention and 3 months later
Secondary Outcome psychological flexibility 3 times- preintervention-immediately at the end of the intervention and 3 months later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hematology Unit in Alexandria Main University Hospital. Safeya Zaghloul Street, Raml Station, Alexandria, Egypt Alexandria 21516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Zeinab Nazeeh Aly Shata Alexandria Gleem Ali fahmy street Alexandria 21619 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Public Health 165 El-Horreya Avenue El-Hadara, Alexandria, Egypt Alexandria 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeinab Shata hiph.zshata@alexu.edu.eg +201007978715 165 El-Horreya Avenue El-Hadara, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Mental Health at High Institute of Public Health Alexandria University
Role Name Email Phone Street address
Public Enquiries Dina Sleem Dinayasser31@yahoo.com +201066684710 Alexandria Gleem Ali fahmy street
City Postal code Country Position/Affiliation
Alexandria 21619 Egypt Hematology consultant Alexandria police hospital
Role Name Email Phone Street address
Scientific Enquiries Ayat Ashour hihp.aashour@alexu.edu.eg +201229953454 165 El-Horreya Avenue El-Hadara, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Assistant Professor of Public Health at High Institute of Public Health Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be publicly shared. De-identified data may be considered upon reasonable request, subject to ethical approval, institutional policies, and data protection requirements. Informed Consent Form,Study Protocol De-identified individual participant data will become available 6 months after publication of the primary results and will remain available for 3 years thereafter, subject to ethical approval and applicable data protection requirements. Access to de-identified individual participant data will be considered upon reasonable request to the principal investigator and subject to ethical approval, institutional policies, and applicable data protection requirements. Data will be provided only for scientifically sound research purposes and will not include information that could directly identify participants.
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
Intervention Intervention List 04/09/2026 We apologize for the misunderstanding regarding the term “group size.” The total sample size for the study is 94 participants, with 47 participants allocated to the intervention group and 47 to the control group. In this study, the intervention is delivered as group therapy rather than individual therapy. Participants in the intervention arm will therefore be further organized into smaller therapy groups, with an average of approximately 10 participants per group. Thus, the term “group size” refers to the number of participants receiving the intervention together within each therapy session, rather than the size of the intervention and control arms. Control Group, no intervention, zero, 5 weeks, no intervention, 47, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 We apologize for the misunderstanding regarding the term “group size.” The total sample size for the study is 94 participants, with 47 participants allocated to the intervention group and 47 to the control group. In this study, the intervention is delivered as group therapy rather than individual therapy. Participants in the intervention arm will therefore be further organized into smaller therapy groups, with an average of approximately 10 participants per group. Thus, the term “group size” refers to the number of participants receiving the intervention together within each therapy session, rather than the size of the intervention and control arms. Experimental Group, Acceptance and Commitment Therapy, one session/week, 5 weeks, The intervention will consist of a five-session, group-based Acceptance and Commitment Therapy (ACT) program for patients with acute myeloid leukemia (AML). The program will include one psychoeducation session and four ACT sessions, delivered weekly to groups of 8–12 patients, with each session lasting 60–90 minutes. The sessions will use interactive methods such as group discussions, role-play, brainstorming, illustrations, vignettes, and audio-visual materials. The program will focus on understanding and accepting AML, mindfulness and acceptance, cognitive defusion, self-compassion and self-as-context, identifying personal values, and developing committed, value-based actions to promote psychological flexibility, reduce psychological distress, and improve quality of life., 10, Experimental Group, Acceptance and Commitment Therapy, one session/week, 5 weeks, The intervention will consist of a five-session, group-based Acceptance and Commitment Therapy (ACT) program for patients with acute myeloid leukemia (AML). The program will include one psychoeducation session and four ACT sessions, delivered weekly to groups of 8–12 patients, with each session lasting 60–90 minutes. The sessions will use interactive methods such as group discussions, role-play, brainstorming, illustrations, vignettes, and audio-visual materials. The program will focus on understanding and accepting AML, mindfulness and acceptance, cognitive defusion, self-compassion and self-as-context, identifying personal values, and developing committed, value-based actions to promote psychological flexibility, reduce psychological distress, and improve quality of life., 47,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/09/2026 The outcomes will be assessed at three time points: week 0 (baseline), week 5 (immediately after completion of the intervention), and week 17 (three months after completion of the intervention). Specifically, week 0 represents the pre-intervention baseline assessment, week 5 represents the post-intervention assessment at the end of the intervention, and week 17 represents the follow-up assessment conducted three months after the intervention Primary Outcome, depressive, anxiety, and stress symptoms., 0 weeks 5 weeks 17 weeks Primary Outcome, depressive, anxiety, and stress symptoms., 3 times- preintervention- immediately at the end of the intervention and 3 months later
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/09/2026 The outcomes will be assessed at three time points: week 0 (baseline), week 5 (immediately after completion of the intervention), and week 17 (three months after completion of the intervention). Specifically, week 0 represents the pre-intervention baseline assessment, week 5 represents the post-intervention assessment at the end of the intervention, and week 17 represents the follow-up assessment conducted three months after the intervention Secondary Outcome, quality of life, 0 weeks 5 weeks 17 weeks Secondary Outcome, quality of life, 3 times- preintervention-immediately at the end of the intervention and 3 months later
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/09/2026 The outcomes will be assessed at three time points: week 0 (baseline), week 5 (immediately after completion of the intervention), and week 17 (three months after completion of the intervention). Specifically, week 0 represents the pre-intervention baseline assessment, week 5 represents the post-intervention assessment at the end of the intervention, and week 17 represents the follow-up assessment conducted three months after the intervention Secondary Outcome, psychological flexibility, 0 weeks 5 weeks 17 weeks Secondary Outcome, psychological flexibility, 3 times- preintervention-immediately at the end of the intervention and 3 months later
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/09/2026 As the study has no external funding source and is entirely self-funded, we have provided the name of the researcher as requested. The researcher, Alexandria Gleem Ali fahmy street, Alexandria, 21619, Egypt, Self Funded, Dina Sleem Ali Mohammed , Alexandria Gleem Ali fahmy street, Alexandria, 21619, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/09/2026 As the study has no external funding source and is entirely self-funded, we have provided the name of the researcher as requested. Alexandria Gleem Ali fahmy street Dr. Zeinab Nazeeh Aly Shata , Alexandria Gleem Ali fahmy street, Alexandria, 21619, Egypt, Self Funded,