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.: PACTR202303734043508 Date of Approval: 14/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of integrating screening and management of depressive symptoms on quality of life and symptom burden among patients living with cancer at Kamuzu Central Hospital in Malawi.
Official scientific title Integrating screening and management of depressive symptoms among patients living with cancer.
Brief summary describing the background and objectives of the trial Depression is a common debilitating mental health disorder among patients with cancer worldwide. In Malawi, a recently published report from January to March in 2021 at Kamuzu and Queen Elizabeth Central hospitals, has indicated that at least 9% of cancer patients suffered from depression. Despite a high burden of depression among this group of patients, there is no routine screening and management of depression among cancer patients in Malawi. Patients living with cancer when diagnosed with depression are referred to psychiatric unit for review which is away from the cancer unit and none of those cases were diagnosed by the attending clinician. This is a missed opportunity considering that depression disorder is a treatable condition if diagnosed and could go a long way in improving quality of life and survival among cancer patients. Aim: We aimed at evaluating the effect of integrating management of depression on cancer clinical outcomes. Objectives: The objectives were as below; 1. To compare quality of life among cancer patients with depression between two arms attending cancer care at oncology clinic at Kamuzu Central Hospital using Euroqol tool. 2. To compare treatment adherence among cancer patients with depression between two arms attending oncology services at Kamuzu central hospital. 3. To estimate 9 months survival among cancer patients with depression between two arms attending oncology clinic at Kamuzu Central Hospital. 4. To evaluate remission of depressive symptoms among cancer patients between two arms. 5. To assess the acceptability of integrating screening and management of depression among cancer patients in the interventional arm and healthcare workers at Kamuzu Central Hospital. 6. To assess the appropriateness of integrating screening and management of depression among cancer patients in the intervention arm at Kamuzu Central Hospital. 7. To assess the feasibility of integrating screening and management of depression among health workers at Kamuzu Central hospital
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 19/07/2021
Actual trial start date 02/08/2021
Anticipated date of last follow up 29/08/2022
Actual Last follow-up date 29/08/2022
Anticipated target sample size (number of participants) 198
Actual target sample size (number of participants) 214
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group screen and treat for depressive symptoms using an integrated approach mild depressive symptoms were managed with friendship bench (psychosocial counseling). Moderate to severe depressive symptoms were treated with combined psychosocial counseling and pharmacotherapy (Fluoxetine 20 mg ) 6 months The study had two arms. The intervention group involved screening and treatment for depression at NCC (integrated approach). The comparison group followed standard practice whereby cancer patients suspected (after screening) of depression were referred to a mental health clinic at the KCH (outside the NCC). 112
Control Group Screen and refer all patients with diagnosed depressive symptoms to mental health clinic mild depressive symptoms were treated with psychosocial counseling. Moderate and severe depressive symptoms were treated with a combination of psychosocial counseling and pharmacotherapy (fluoxetine 20 mg daily) 6 months screening and treatment of depressive symptoms 102 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients aged above 18 years and had cancer were included in the study. Those who did not consent for the study and were not able to respond to the questions were excluded. Adult: 19 Year-44 Year 18 Year(s) 70 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 16/10/2020 COMREC
Ethics Committee Address
Street address City Postal code Country
Off Mahatma Gandhi Campus Blantyre 00265 Malawi
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 16/06/2021 COMRED
Ethics Committee Address
Street address City Postal code Country
Off Mahatma Gandhi campus Blantyre 00265 Malawi
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 05/08/2022 COMREC
Ethics Committee Address
Street address City Postal code Country
Off Mahatma Gandhi campus Blantyre 00265 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Remission of depressive symptoms 1, 2, 3,4, 5, 6 months of follow-up
Primary Outcome Quality of life 1, 2, 3,4, 5, 6 months of follow-up
Secondary Outcome Feasibility, acceptability and appropriateness of integrating screening and treatment for depressive symptoms 1, 2, 3,4, 5, 6 months of follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National cancer center at Kamuzu Central Hospital Chipatala avenue Lilongwe 0065 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
CEBHA Marchioninistr. 15 Munich 049 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor German Federal Ministry of Education and Research Marchioninistr. 15 Munich 049 Germany Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Leo Masamba Off Mahatma Gandhi campus Blantyre 00265 Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jonathan Chiwanda Banda jonchiwanda@gmail.com +265999768769 A2 street, Area 49
City Postal code Country Position/Affiliation
Lilongwe 00265 Malawi PhD student at Kamuzu University of Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Adamson Muula amuula@medcol.mw 002658842386 Off Mahatma Gandhi campus
City Postal code Country Position/Affiliation
Blantyre 00265 Malawi Supervisor
Role Name Email Phone Street address
Public Enquiries Michael Udedi mphatsoudedi@yahoo.co.uk 00265994253002 Capital Hill avenue
City Postal code Country Position/Affiliation
Lilongwe 00265 Malawi Mentor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification will be considered for sharing subject to formal request submission to the principal investigator. Clinical Study Report,Informed Consent Form,Study Protocol All the IPD additional documents will be considered for sharing from 1st September,2023 to 30th August, 2025. Controlled access of secondary data will be available for sharing subject to formal written request submitted to the investigator by anyone holding a minimum of first university degree and a determination will be made in liaison with the primary supervisor.
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