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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011629348967 Date of Approval: 20/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect Of Interpersonal Psychotherapy On Quality Of Life Among Breast Cancer Patients With Common Mental Disorder: A Randomized Control Trial at Tikur Anbessa Specialized Hospital.
Official scientific title The Effect Of Interpersonal Psychotherapy On Quality Of Life Among Breast Cancer Patients With Common Mental Disorder: A Randomized Control Trial at Tikur Anbessa Specialized Hospital.
Brief summary describing the background and objectives of the trial Background: Depression and anxiety are forms of mental health problems that are common among cancer patients. However, the impact of Interpersonal Psychotherapy on anxiety, depression, and quality of life on cancer patients is not well studied in Ethiopia. Therefore, this study was aimed to determine the effect of Interpersonal Psychotherapy on anxiety, depression, and quality of life among Breast Cancer patients at Tikur Anbessa Specialized Teaching Hospital (TASH), Addis Ababa, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IPT
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 16/02/2019
Actual trial start date 01/03/2019
Anticipated date of last follow up 13/08/2019
Actual Last follow-up date 26/08/2019
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 114
Recruitment status Completed
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interpersonal Psychotherapy for Ethiopian Use Once a week for a maximum of six weeks. For six weeks. Inter-Personal Psychotherapy Adapted for Ethiopian Use (IPT-E) IPT is a brief manualized Psychotherapy that has been adapted for low-income countries including Ethiopia through a series of trials that demonstrated its relevance and efficacy across cultures (30-36). It is recommended in international consensus treatment guidelines for depression. It also helps patients who struggle with psychological distress and psychiatric symptoms of common mental health disorders (CMDs) which consists of depression, anxiety, and somatoform disorders or medically unexplained symptoms. IPT is believed to be helpful for these disorders or disturbances in the context of stressful relationships where there is loss and bereavement, role transitions, and life changes or disagreements and disputes. As per the IPT-E guideline, the therapeutic process consists of the beginning phase, middle phase, and that of the final phase. IPT-E session consists of a total of 4-8 sessions. However, in this study, the intervention involved 4-6 therapy sessions. BEGINNING TASKS: At the beginning (1st session) the therapist asked the patients questions that help to understand their problems, symptoms, explanatory model, and psychosocial supports. Here therapeutic relationship, provision of feedback, and identification of IPT problem areas (loss, change, or disagreements) were established for the focus of the middle phase sessions. MIDDLE PHASE TASKS: In this phase (2nd and 3rd sessions) the therapist was working through aspects of underlying interpersonal problems and helping patients to connect with supports. Even though it is recommended to focus on one problem area, the therapist sometimes can extend the therapeutic focus to other areas when it is believed to be saliently linked to current distress. FINAL PHASE TASKS: During the final session (4th session), the patient’s efforts and progress were reviewed. Contingency plans were made in case of symptoms worsen. Further, old losses were processed and `symptoms` that might 57
Control Group Standard treatment Control groups were taking their routine treatment as per the standard As per prescribed or needed For the Control groups took their standard treatment such as Chemotherapy, radiotherapy and hormonal therapyprescribed period of time 57 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were included when Breast Cancer patients were 1) aged 18 years and above 2)those who are diagnosed with anxiety and depression using HADS (HADS>=8) at Tikur Anbessa Specialized Teaching Hospital oncology center, Addis Ababa, Ethiopia. Participants were excluded from the study when they were on 1) severe physical illness 2) severe mental illness (psychosis & mania), 3) functionally impairing substance abuse, 3) and Patients who are acutely suicidal were excluded from the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 28/01/2019 Institutional Ethical Review Board of Addis Ababa University.
Ethics Committee Address
Street address City Postal code Country
Near to Seweden Embassy at Tikur Anbessa Hospital Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome The primary outcomes were level of depression and anxiety. It was measured using Ethiopian validated Hospital Anxiety and Depression measurement scale (HADS) which showed good consistency between the items and high test-retest reliability. HADS is a widely used health-related quality of life instrument for measuring psychological distress in non-psychiatric patients. The items are rated on a four-point Likert scale ranging from 0 to 3 giving maximum and minimum scores of 0 and 21 respectively for each subscale. Sub-scores on the anxiety or depression sub-scales ranging from 0 to 7 are considered normal; while 8 to 10 and 11 to 21 are considered to cause for concern’ and ‘probable cases of anxiety or depression’ respectively. The interpretation of HADS measurement scale is as follows:- • 0 to 7--- normal • 8 to 10----- mild • 11 to 14 ----- moderate and • 15 to 21----- severe. One month after the final therapy session.
Secondary Outcome The secondary outcome of this study was the quality of life. It was assessed using the Amharic version of EORTC QLQ-C30 that is found to be reliable and had an acceptable validity to assess the QOL among cancer patients. The questionnaires have 30 items with three scales and 15 different domains. The three scales used were functional, symptom scale, and general health status as a separate scale. Domains such as physical, role, cognitive, emotional, and social functioning under functional scale whereas dyspnea, pain, fatigue, insomnia, appetite loss, nausea/vomiting, constipation, diarrhea as well as financial difficulties under symptom scale and general health status as a separate scale. The scoring was done according to the Quality of life questionnaire-C30 manual. According to the manual, the quality of life questionnaire version-3 has 30 item questions to assess the quality of life of cancer patients in general. So after the patients' response was taken carefully using questions ranging from Item 1(I1to Item 30 (Iзȯ), the raw score was calculated and further be used for each scales (Functional, symptom and general health status), then linear transformation were undertaken for each domain under the subsequent scales. This raw score was further be used for each scale (Functional, symptom, and general health status), then linear transformation was undertaken for each domain under the subsequent scales. The linear transformation from 0-100 was applied to obtain the score S, the individual score for each domain. The linear transformation was done to use individual scores for the subsequent analysis. The formula written below was used for functional, symptom scale, and general status. Functional scales: S= 1- (RS-1) *100 Range Symptom scales/items: S=RS −1range100 Global health status / QoL: S RS −1range100 Accordingly, range (R) is the difference between the maximum possible value an One month after the final therapy session.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tikur Anbessa Specialized Teaching Hospital Zambia St near to Seweden Embassy, Addis Ababa Addis Ababa 9086 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University. Near to Seweden Embassy Addis Ababa 9086 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Catholic Organization for Relief and Development AID school of public health female cancer initiative. Tikur Anbessa Hospital near to Seweden Embassy Addis Ababa 9086 Ethiopia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Werisaw Haileselassie Near to Seweden Embassy Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Winini Belay wininiquidnac@gmail.com 251921388192 Near to seweden Embassy
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Department of Reproductive health and Health System Management School of Public Health Addis Ababa University.
Role Name Email Phone Street address
Scientific Enquiries Winini Belay wininiquidnac@gmail.com 251921388192 Near to seweden Embassy
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Department of Reproductive health and Health System Management School of Public Health Addis Ababa University.
Role Name Email Phone Street address
Public Enquiries Winini Belay wininiquidnac@gmail.com 251921388192 Near to seweden Embassy
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Department of Reproductive health and Health System Management School of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants' data in Stata format. Informed Consent Form Within one month. As per the request of the registry committee, I will personally share the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information