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.: PACTR202501810755828 Date of Registration: 16/01/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF SPIRITUAL OR RELIGIOUS LEADERS MESSAGE ON PATIENTS WITH BREAST AND CERVICAL CANCER
Official scientific title The effect of spiritual or religious leaders' messages on the quality of life of breast and cervical cancer patients receiving treatment at the Hawassa University Comprehensive Specialized Hospital Cancer Treatment Center
Brief summary describing the background and objectives of the trial Background: Breast and cervical cancers are the leading causes of cancer-related mortality among women in low-income countries. There is a scarcity of research on the psychosocial and spiritual needs of cancer patients in African nations, highlighting the need to address the religious concerns of patients and their impact on quality of life. Objectives: The aim of this trial is to investigate the effect of messages from religious or spiritual leaders on the quality of life of patients with breast and cervical cancer. Method and Materials: A randomized controlled trial will be conducted to determine the impact of religious leaders' messages on the quality of life at three months and six months after initiating chemotherapy in patients with breast and cervical cancer. The trial will take place at the university hospital's cancer treatment center. A total of 112 patients will be recruited, with 56 in the intervention group and 56 in the control group. Valid and reliable instruments will measure the primary outcome of quality of life and the secondary outcome of spiritual well-being. Data will be collected at baseline and follow-up using a mobile application, following training for data collectors. Statistical analysis will be performed using SPSS version 27. Ethical approval will be secured from the Institutional Review Boards of Martin Luther University-Halle-Wittenberg and Hawassa University College of Medicine and Health Sciences.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RLMQOL
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 10/02/2025
Actual trial start date 01/04/2025
Anticipated date of last follow up 11/08/2025
Actual Last follow-up date 01/09/2025
Anticipated target sample size (number of participants) 112
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group video based massage from religious leader Three times during the chemotherapy cycle the intervention will not exceed 30 minutes The content of the video message will be developed after identifying the gaps in supportive care needs and spiritual well-being among patients with breast and cervical cancer. Following the findings, the video message will be created and provided to patients beginning their chemotherapy at the cancer treatment center. During the initial delivery, a nurse from the center will assist the patient and gather any questions. Inquiries from the initial video session will be addressed by the same religious leader during the next chemotherapy cycle. The patient will be seated in a private room throughout all the sessions of message delivery. The video message will be shown during the one-hour interval typically present between chemotherapy preparation and administration in our facility. The same message will be presented to the patient during the fifth cycle, at which point end-line data will also be collected. Participants in the control group will receive standard care and a video explaining the cancer treatment process. A standard operating procedure will be established for this intervention 56
Control Group video on the general information on cancer treatment twice, at the beginning and at the fifth cycle of the chemotherapy for 5 minutes video related to cancer treatment will be prepared and delivered to the patients 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All female adult patients Newly diagnosed with cancer and cervical cancer and attending their treatment at the Hawassa University Comprehensive Specialized Hospital cancer treatment center Patients who commence their treatment with chemotherapy Patients under 18- years -old will be excluded. Breast or cervical cancer patients who have a family member who is a priest/pastor/or imam/nurse/health officer/physician will be excluded from the study. Patients unable to respond or talk related to oral problems Metastasis of breast or cervical cancer to the head and or neck will not be included. over 80 years of age 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) 80 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 05/12/2024 Hawassa university college of medicine and health sciences Institutional review board
Ethics Committee Address
Street address City Postal code Country
Hawassa, Sidama Ethiopia Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of life sixth months
Secondary Outcome Spiritual wellbeing and chemotherapy cycle completion rate sixth month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hawassa university comprehensive specialized hospital cancer treatment center Hawassa, Sidama Ethiopia Hawassa 1560 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
City of hope National medical center Duarte, California, USA Los Angeles United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor City of hope national medical center Duarte, California Los Angeles United States of America Hospital
COLLABORATORS
Name Street address City Postal code Country
Marthin Luther University Magdeburger street 08 Halle Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bedilu Deribe Derese bediluderibe2002@gmail.com +251933220151 Hawassa Mery joy
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Hawassa university college of medicine and health science school of nursing
Role Name Email Phone Street address
Public Enquiries Lesley Taylor ltaylor@coh.org +16463352507 Duarte, Los Angeles County, CA, USA
City Postal code Country Position/Affiliation
Los Angeles United States of America City of Hope Comprehensive Cancer Center Division of Breast Surgery
Role Name Email Phone Street address
Scientific Enquiries Susanne Unverzagt usanne.unverzagt@uk-halle.de +491624962696 Magdeburger Street 8
City Postal code Country Position/Affiliation
Halle Germany Martin Luther University Halle institute of family medicine and general practice
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data to be shared will encompass demographic details such as age, gender, residence, education level, and socioeconomic status, along with both primary and secondary outcomes. Survey responses will also be gathered to capture participant opinions, experiences, and satisfaction levels. To protect participant confidentiality, all data will be anonymized, removing any personally identifiable information from the dataset. Informed Consent Form,Statistical Analysis Plan,Study Protocol one year There will be controlled data access with no limit on the analysis plan
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
Trial Information Actual trial start date 14/11/2024 Expect logistical issues in the cancer treatment center. 01 Apr 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/11/2024 One month is added to ensure that all patients are included and the intervention is completed. 01 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/11/2024 Unless they die, we will follow them until the end of the intervention. 112
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/01/2025 this is not change, it is an approval letter extension. TRUE, Hawassa university college of medicine and health sciences Institutional review board , Hawassa, Sidama Ethiopia, Hawassa, 1560, Ethiopia, , 04 Dec 2024, +251468209290, embialle@hu.edu.et, 31817_30001_4737.pdf TRUE, Hawassa university college of medicine and health sciences Institutional review board , Hawassa, Sidama Ethiopia, Hawassa, 1560, Ethiopia, , 04 Dec 2024, +251468209290, embialle@hu.edu.et, 31817_30001_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/01/2025 Here is the approval extension. The date discrepancy is a typing error; the correct date is indicated in the attached letter. TRUE, Hawassa university college of medicine and health sciences Institutional review board , Hawassa, Sidama Ethiopia, Hawassa, 1560, Ethiopia, , 04 Dec 2024, +251468209290, embialle@hu.edu.et, 31817_30001_4737.pdf TRUE, Hawassa university college of medicine and health sciences Institutional review board , Hawassa, Sidama Ethiopia, Hawassa, 1560, Ethiopia, , 05 Dec 2024, +251468209290, embialle@hu.edu.et, 31817_30001_4737.pdf